Journal of Psychosomatic Research 61 (2006) 187 – 196 Cognitive–behavior group intervention for relatives of cancer patients: a controlled study Miri Cohena,T, Abraham Kutenb a Faculty of Social Welfare and Health Studies, School of Social Work, Haifa University and Social Work Department, Rambam Medical Center, Haifa, Israel b Oncology Department, Rambam Medical Center, Haifa, Israel Received 3 December 2004 Abstract Objective: The objective of this study was to assess the effect of cognitive–behavior (CB) group intervention on the psychological distress and adjustment of relatives of cancer patients with a primary disease. Methods: A total of 52 relatives of cancer patients participated in a CB group intervention, whereas another 52 served as control subjects. All participants completed preintervention and postintervention measures and a 4-month follow-up questionnaire consisting of the Brief Symptom Inventory (BSI), the Psychological Adjustment to Illness Scale (PAIS), the Mini Sleep Questionnaire, and the Multidimensional Scale of Perceived Social Support; participants in the group intervention also reported compliance with home practice. Results: Participants in the intervention group scored significantly lower than the control subjects on the BSI and the PAIS, recorded fewer sleep difficulties in the postintervention and follow-up measures, and reported higher perceived support in the follow-up measure. By contrast, no significant change was observed in the control group during the study period. On the reliable change index, 30.8% of the intervention participants but only 3.9% of the control subjects had statistically significant improvements in their psychological distress. Improvement in the intervention group was associated with higher compliance with home practice. Conclusion: This study provides evidence for the positive effect of a CB group intervention for family members, which lasted for 4 months after the intervention ended. D 2006 Elsevier Inc. All rights reserved. Keywords: Relatives; Cancer patients; Cognitive–behavior group intervention; Compliance; Home practice Introduction The impact of cancer on patients’ relatives, especially their spouses, has been widely studied [1– 6], with general confirmation of the notion that they experience high levels of psychological distress [3,5,6] resembling those of the cancer patients themselves [4,7]. Even higher distress levels in relatives than in patients have been reported [8,9]. Other studies found impaired psychosocial adjustment of relatives to cancer illness [2,10,11]. Despite these information, surprisingly few studies report psychosocial interventions with cancer patients’ relatives. Some early reports described group interventions [12 –14] with small numbers of participants and without control groups. The still fewer controlled studies that could be T Corresponding author. E-mail address: [email protected] (M. Cohen). 0022-3999/06/$ – see front matter D 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.jpsychores.2005.08.014 located were conducted in the United States. Goldberg and Wool [15] provided an unstructured supportive intervention for the spouses and adult children of lung cancer patients. They found no difference in the levels of psychosocial adjustment or in psychological distress between the 23 participants and the control subjects. A more recent randomized controlled study involved 66 spouses and included a followup [16]. A problem-solving intervention based on a standardized protocol was offered to the intervention group. No difference in psychological distress, perceived health, or perceived social support was found between the intervention and the control groups. Manne et al. [17] evaluated the effects of a six-session psychoeducational group intervention on distress levels in 60 spouses of prostate cancer patients in a randomized clinical trial. This was a structured group, and a different topic was presented each session. Information was provided on medical issues, nutrition, stress management and coping skills, communication, intimacy, and posttreatment 188 M. Cohen, A. Kuten / Journal of Psychosomatic Research 61 (2006) 187 – 196 concerns. Again, no difference between the intervention and control groups with regard to general distress or cancerspecific distress was noted. A cognitive – behavior (CB) model of intervention with cancer patients was developed by Moorey and Greer [18] based on the cognitive theory of Beck [19]. The model proposes that the negative appraisals, interpretations, and meanings that individuals attribute to cancer and its treatments determine their emotional and behavioral reactions and the way they adjust to the situation. CB therapy aims to create a realistic interpretation of the stresses involved in adjusting to cancer, eliciting ways to cope effectively with them and to acquire and mobilize efficient coping behaviors [18,20]. Additional cognitive techniques are mental distraction, reframing, problem solving, and decision-making strategies [18]. The behavioral component consists of learning and exercising relaxation and guided imagery and is aimed at reducing levels of stress and anxiety. In addition, techniques such as distraction and establishing a daily schedule and activities are used [18,19]. The growing trend to provide cancer patients with CB intervention with favorable outcomes [18,21,22] is lacking from reports on interventions with relatives [18,23]. Moorey and Greer [18] reported using the CB model with couples; however, to the best of our knowledge, no report on group CB therapy for relatives has been published. Yet a CB therapy may be helpful in relieving psychological distress in relatives too. It may help them reduce psychological distress through restructuring negative appraisals of cancer and its impact on their lives and of the demands and strains of caring. Another possible target of CB therapy for relatives should be to teach them how to have their support needs met and improve appraisals of the support they receive from their family and their social network. Several studies reported that relatives who perceived receiving greater support coped better with the strain of caring for a cancer patient [10,24,25], whereas other studies suggested that positive support has no effect on psychological distress (reviewed in Ref. [1]). Psychological distress is often associated with the onset or worsening of sleep difficulties, which has a negative impact on quality of life (e.g., impairments in concentration and memory, coping capacity, mood, and physical health [26]). Studies have suggested that CB techniques can produce a meaningful improvement in the quality of sleep [26,27]. The improvement may be caused by the lowering of levels of anxiety and depression [28,29]. Moreover, research has demonstrated that relaxation improves quality of sleep [30] by reducing autonomic arousal [29–31] or raising melatonin levels [32]. Relaxation techniques can be used as a direct means for falling asleep as well [23]. Accordingly, this study was designed to assess the effect of a CB group intervention for relatives on their psychological distress, sleep difficulties, perceived support, and psychosocial adjustment to cancer in the ill family member, as compared with a nonintervention group. Our first hypothesis was that participants in the CB group would score lower than the control subjects on psychological distress, sleep difficulties, and adjustment and higher on perceived social support by the end of the sessions. Most studies on the effect of group interventions have measured statistically significant changes, from pretreatment to posttreatment, by means of the studied variables and their effect size. Recently, researchers have noted that a statistically significant change, even with a considerable effect size, may not be a clinically significant change; they have devised other ways to identify the significance of change. The statistical approach to evaluate the clinical significance of change by Jacobson and Truax [33], known as the reliable change index (RCI), was used in this study. Based on this approach, the change from pretreatment to posttreatment undergone by each individual was examined and determined significant if the observed change was beyond the limits of chance variation. A major advantage of the RCI is that it accounts for error variance owing to measurement [33]. This allows a more precise evaluation of change in individual patients. Thus, our second hypothesis was that more participants in the CB group would exhibit a clinically significant change in the studied variables posttreatment, which would persist in a follow-up. Methods Participants and procedure From 2001 to 2004, relatives of cancer patients with a primary and localized disease receiving either chemotherapy or radiotherapy treatment, regardless of time elapsed since diagnosis, were invited to participate in the study. They were recruited by social workers and nurses in the outpatient unit of the oncology department of the Rambam Medical Center in Haifa, Israel, after the patients’ permission was obtained. Stipulations for eligibility were that participants be aged between 24 and 75 years, spoke fluent Hebrew, were not receiving psychiatric medication, and were themselves not present or past cancer patients. Only one relative from each patient’s family participated in the study. Relatives received information about the study and its aims and gave their informed consent to participate. The control group consisted of relatives who had initially agreed to participate in the group intervention but before it started found that they could not attend because of practical reasons (e.g., time of the sessions and small children at home). This way was chosen because the number of relatives wishing to participate was too low for a random selection. The high rates of refusal and dropout from groups for cancer patients’ relatives have been previously noted [23]. Although not chosen at random, all participants in the control group had initially wished to join the therapy group, so, presumably, they constituted a satisfactory control group. M. Cohen, A. Kuten / Journal of Psychosomatic Research 61 (2006) 187 – 196 Of the 552 eligible relatives approached, 409 refused to participate in this study. Of the final sample, 80 relatives were assigned to the intervention group and 63 relatives were assigned to the control group. Of the intervention participants, 18 declined to continue participating after the group started (7 participants opted out because of their ill relative’s medical complications, 6 could not adjust themselves to the group schedule, and 5 resigned after the group started because they felt that the group intervention did not suit their needs). Another 10 patients from the intervention group missed more than two meetings and were not included in the study, and 4 participants failed to complete the questionnaires at one or more of the time points and were excluded from the study. Finally, the intervention group consisted of 52 participants. Of the control subjects, 11 failed to complete all questionnaires, which resulted in 52 participants too. Eight CB groups, meeting for nine sessions of 90 min each, were conducted consecutively. Each group had five to seven participants. Relatives in the control group received the standard psychosocial care from a multiprofessional team. 189 This care consisted of support from a social worker and nurses in the oncology unit and mediation in receiving tangible aid from sources in the community. They were invited to attend a new group intervention when the study ended. All participants completed questionnaires at three time points: Time 1, preintervention; Time 2, after 9 weeks after the intervention ended (postintervention); and Time 3, 4 months after the intervention ended (i.e., the 25th week of the study). The study was approved by the hospital’s ethics committee. CB group intervention The intervention was conducted according to a manual for CB group intervention prepared in our psycho-oncology unit. The manual was based on the cognitive theory of Beck [19], the CB model of Moorey and Greer [18], and the model of relaxation and guided imagery of Baider et al. [34]. The model was implemented at the Rambam Medical Center’s Oncology Department, and clinical experience with the intervention was acquired prior to the study. Groups Table 1 Structure and content of CB sessions and home practice Session Content Home practice for the following week 1 Acquaintance, expectations, group contract Introduction to the program and to CB (start of making distinctions between emotions and thoughts) Primary experience with relaxation and guided imagery Introduction to the concept of automatic thoughts and their relation to emotions through working on examples from participants’ lives; emotional expression Relaxation and guided imagery with focus on learning to relax the head and face muscles Introduction to the concept of challenging thoughts and thought distortions; relaxation and guided imagery with focus on the nape, shoulders, and hand muscles Identifying and challenging beliefs Learning problem-solving and coping skills Relaxation and guided imagery with focus on the back, bottom, and legs Continue work on thoughts, beliefs, and problem solving Learning cognitive and behavioral distracting techniques Practicing relaxation and guided imagery with focus on chest and abdominal muscles and learning deep breathing Using the CB model with focus on issues of anxiety and arousal Introduction to techniques for sleep problems Practicing complete relaxation and guided imagery Identifying and rating the intensity of emotions during the week 2 3 4 5 6 7 8 9 Using the CB model with focus on issues of communication and managing anger Practicing complete relaxation and guided imagery; learning immediate relaxation techniques for daily situations of arousal in anxiety, stress, or anger Using the CB model with focus on issues of depressed mood Practicing complete relaxation and guided imagery and immediate relaxation techniques Setting goals and reinforcement of strategies Overview of the group, feedback, and ending Monitoring and recording emotions and thoughts; practicing relaxation and guided imagery Monitoring and recording emotions, thoughts, alternative thoughts, change in emotions; practicing relaxation and guided imagery Continued recording of the complete model (described above); practicing problem solving; practicing relaxation and guided imagery Continued recording of the complete model Practicing problem solving and distracting Practicing relaxation and guided imagery Continued monitoring of the complete model Practicing problem solving and distracting Practicing relaxation and guided imagery (handing out relaxation and guided imagery audio disc/cassette) Continued monitoring of the complete model Practicing problem solving and distracting Practicing relaxation and guided imagery Continued monitoring of the complete model Practicing problem solving and distracting Practicing relaxation and guided imagery 190 M. Cohen, A. Kuten / Journal of Psychosomatic Research 61 (2006) 187 – 196 were conducted by a senior social worker who had extensive experience and training in psycho-oncology, group therapy, and CB therapy. The sessions were structured, and each consisted of cognitive and behavioral components (Table 1). The cognitive techniques focused on learning to elicit negative thinking patterns, learning to identify and monitor automatic thoughts and beliefs and to challenge and restructure them in more adaptive patterns, and finding alternative responses for recurrent stressful situations. In addition, reframing and problem solving were taught. Behavioral techniques consisted of systematic learning of relaxation, guided imagery, and deep breathing. Cognitive and behavioral distraction strategies were likewise introduced. Expression of emotions and building mutual support were encouraged too, although these were not the focus of the intervention. The participants gradually learned the CB skills (Table 1). They began by identifying emotions and grading their intensity and then moved on to identifying and monitoring negative thought and beliefs, challenging them, and grasping the cognitive distortions caused. Next, they elicited alternative thoughts and tracked the successive intensities of their emotions. From the second session, each meeting started with a review of the home practice. Next, a new topic was introduced, discussed, and experienced. In this part of the session, participants shared and explored their emotions with the group and used the opportunity to apply the strategies to their personal situation. In subsequent sessions, common issues such as managing stress, anxiety, anger, and sleep difficulties were addressed. Also, distancing and problemsolving techniques were introduced and exercised. This activity covered the first hour of each session. The last half hour was devoted to progressive learning of deep relaxation and guided imagery [34]. In each session, a different guided imagery was suggested (e.g., a seashore, a spring, an open field). The participants had the opportunity to experience and discuss various sensations and reactions to different elements of the relaxation and guided imagery. Feedback was given in the last part of the session and home practice was assigned. Participants gradually acquired the experience needed to conduct relaxation and guided imagery successfully on their own and to implement it for specific situations (e.g., anxiety arousal and sleep difficulties). Participants were provided with written materials and home practice at every session. The handouts included an explanation of CB techniques, sheets for successive recording of identified emotions (type and intensity), thoughts and beliefs underlying the emotions, alternative thoughts, and changes in emotion intensity. Participants were asked to practice the cumulatively learned CB techniques. Participants received written instructions for relaxation and guided imagery for the week following each session according to the techniques practiced during the session; at the sixth session, by which the whole model of relaxation/guided imagery had been learned, they were given the relaxation/guided imagery audiocassettes or compact discs for further practicing. Instruments Brief Symptom Inventory The Brief Symptom Inventory is a shortened (53 items) version of the SCL-90-R [35]. It is a well-tried instrument designed to assess psychological distress and has been shown to possess good psychometric properties [36]. It was found appropriate for the Israeli population [37]. It is composed of nine symptom dimensions: somatization, obsessive– compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). In our study, a Global Severity Index (GSI) was calculated as the mean of all item scores. The GSI is a sensitive indicator of psychological distress because it reflects information on both the number and severity of symptoms [36]. The internal consistency (a) values of the GSI at the three time points were .91, .87, and .90, respectively. Psychological Adjustment to Illness Scale–Self-Rating The Psychological Adjustment to Illness Scale–SelfRating (PAIS-SR) [38] contains 46 items that cover seven domains of psychosocial adjustment: health care orientation, vocational environment, domestic environment, sexual relations, extended family relationships, social environment, and psychological distress. The PAIS has been proven to have good psychometric properties. Its validity and reliability have been established in relatives of cancer patients [39]. Items are rated on a 4-point scale from 0 (no problems) to 3 (a multiplicity of problems). The total score of psychosocial adjustment was used in this study; a higher total score reflected worse overall adjustment. The internal consistency (a) values of the PAIS-SR at the three time points were .87, .84, and .85, respectively. Mini Sleep Questionnaire The Mini Sleep Questionnaire [40] is a 10-item self-report that measures problems with falling asleep, restless sleep, and early awakening in the morning. Answers are given on a 7-point scale from 1 (never) to 7 (always). Higher scores reflect more sleeping difficulties. A total sleep difficulties score is calculated. There are four categories of sleep difficulties: 10 –24 points, good sleep quality; 25 –27 points, mild sleep difficulties; 28 –30 points, moderate sleep difficulties; and z31 points, severe sleep difficulties. In our study, the internal consistency (a) at the three time points ranged from .87 to .89. Multidimensional Scale of Perceived Social Support The Multidimensional Scale of Perceived Social Support [41] is a 12-item instrument designed to measure perceived M. Cohen, A. Kuten / Journal of Psychosomatic Research 61 (2006) 187 – 196 social support from three sources: a significant person, the family, and friends. The items are rated on a seven-point Likert scale. Higher scores reflect higher perceived support. Internal consistency (a) ranged from .92 to .95 for the three subscales. Compliance with Home Practice Compliance with home practice was assessed by two questions: (1) how many times a week (average of the 2 previous weeks) participants performed the relaxation and guided imagery exercise (at least 10 min) and (2) how many times a week participants performed the written automatic thought monitoring. Answers ranged from 0 (none) to 7 (everyday or more often). Data analysis Data were analyzed by means of the SPSS 12 program for Windows. Repeated-measures analysis of variance (ANOVA) was used to determine the changes over the three time points for each outcome variable (GSI, PAIS, sleep difficulties, and perceived support). This was a 2 (group: intervention, control) 3 (time point: Time 1=preintervention, Time 2=postintervention, Time 3= 4 months after) model. Contrast analyses were used to test for changes in the outcome measures from pretreatment through posttreatment to follow-up. Within-subject effects for each group were assessed for each pair of time points. Requirements of homogeneity of variance and compound symmetry (assessed by the Mauchly Test of Sphericity) were met for the perceived support and sleep difficulties scales. For GSI and PAIS, the requirements were not met, and the Greenhouse– Geisser epsilon correction was used [42]. A P value V.05 was used for statistical significance; all probability values were two tailed. Regression analysis was conducted for the intervention group only, in which the total change at Time 3 in each of the outcome variables was the dependent variable. The initial score was entered first, then sex, time since diagnosis, and compliance (at Time 3) with home practice. Effect size estimates (partial D2) were reported to indicate the proportion of variance that was accounted for by an effect [43]. In general, effect size values for partial D2 are regarded as small at .01, medium at .06, and large at .14 [43]. In addition, we assessed whether the psychological distress in participants had eased to a clinically significant degree by calculating the RCI for each participant using the method suggested by Jacobson and Truax [33]. The RCI indicates whether a change in scores between the measurement times reflects more than incidental fluctuations of measurement. The RCI was calculated using the equation RCI=X 2X 1/S diff. The preintervention and postintervention score difference was divided by the standard error of difference between the two test scores, which was calculated from the standard errorffi qffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi 2 of measurement (S.E.) by the formula Sdiff ¼ 2ðS:E:Þ . When the RCI is N1.96, the change is considered statistically significant [33]. 191 Results Sociodemographic characteristics The demographic characteristics of the intervention participants, the control subjects, and those who declined to participate are shown in Table 2 (for those who declined, only age, sex, education, and kinship variables are presented because they did not give informed consent to have the medical files of their family member looked into or to fill any other questionnaire). m2 test, t test, or ANOVA was conducted to compare demographic and patients’ illnessrelated differences between the intervention, control, and refusal groups (Table 2). The characteristics of the three groups were not statistically different. Psychosocial measures Table 3 presents the mean values and standard deviations of the scores of the study and control groups for the psychosocial measures across the three time points (pretreatment, posttreatment, and follow-up), the repeated-measures analyses, and the effect sizes of results. Table 2 Demographic and clinical characteristics Age Mean S.D. Range Education Mean S.D. Range Sex [n (%)] Female Male Kinship [n (%)] Spouse Son/daughter Parent Other Patient’s disease [n (%)] Breast Colon Prostate Gynecological Other Marital status [n (%)] Married Single Divorced Widower Employed Religiosity [n (%)] Secular Mildly religious Very religious Intervention (n=52) Control (n=52) Refused to participate (n= 409) 53.3 14.7 25 –72 52.6 12.1 24 – 69 53.9 16.5 27–73 12.3 3.5 8 –17 12.9 2.3 8 –18 13.2 3.1 8 – 20 36 (69.2) 16 (30.8) 33 (63.5) 19 (36.5) 265 (64.8) 144 (35.2) 24 12 9 7 (46.2) (23.1) (17.5) (13.5) 27 9 8 8 (51.9) (17.3) (15.4) (15.4) 208 78 56 67 21 14 4 6 7 (40.4) (26.9) (7.7) (11.5) (13.5) 22 12 5 8 5 (42.3) (23.1) (9.6) (15.4) (9.6) – – – – – 40 3 7 2 40 (76.9) (5.8) (13.5) (3.8) (76.9) 41 2 6 3 38 (78.8) (3.8) (11.6) (5.8) (73.1) – – – – – 33 (63.4) 16 (30.8) 3 (5.8) – – – 28 (53.8) 21 (40.4) 3 (5.8) (50.9) (19.0) (13.7) (16.4) 192 M. Cohen, A. Kuten / Journal of Psychosomatic Research 61 (2006) 187 – 196 Table 3 Mean values (S.D.) of outcome variables (by time and group) Variable GSI Time 1 Time 2 Time 3 Sleep difficulties Time 1 Time 2 Time 3 PAIS Time 1 Time 2 Time 3 Perceived support Time 1 Time 2 Time 3 Intervention Control 0.66 0.41 0.52 0.34 0.46 0.49 0.64 0.72 0.73 0.33 0.48 0.50 30.33 22.58 22.31 11.47 10.05 11.26 29.31 28.52 29.77 12.28 12.26 11.52 1.79 1.29 1.32 0.98 0.86 1.07 1.65 1.82 1.84 0.81 0.85 0.83 5.80 6.02 6.58 3.41 4.26 3.92 6.03 5.82 5.18 4.25 4.19 4.22 Group (1, 101) Time (1, 101) Group Time (1, 101) Effect size 9.09T 0.09 21.74TT 0.18 4.86T 3.92T 11.64TT 0.11 4.49T 6.24T 11.54TT 0.11 2.93 2.27 11.82TT 0.13 T Pb.01. TT Pb.001. At pretreatment, the psychosocial measures (GSI, PAIS, sleep difficulties, PAIS and perceived support) were similar in both groups, with no significant difference between them. The participants’ mean GSI scores were similar to those of the spouses of breast cancer patients in a previous study in Israel [2]. Participants in both our groups reported having sleep difficulties at the upper end of the moderate score [40]. PAIS scores were worse than those previously reported for relatives (parents of adult cancer patients) [44]. However, participants in both groups perceived fairly high support from their social network (a score of 5.9 of a maximum of 7). Repeated-measures ANOVA indicated that significant Group Time interactions existed for all the psychosocial variables, pointing to a significant reduction in GSI, PAIS, and sleep difficulties and an increase in perceived support in the intervention group, but not in the control group, over time. Group main effects were significant for GSI, PAIS, and sleep difficulties but not for perceived support. Time main effects were significant for sleep difficulties and PAIS. The overall effect size of between-group differences ranged from .11 to .18 (Table 3), which indicates a medium-to-high effect [43]. Contrast analyses revealed that for GSI, the Group Time interactions were significant for Time 2 scores as against Time 1 scores [ F(2, 101)=34.61; Pb.0001] and for Time 3 scores as against Time 2 scores [ F(2, 101)=5.09; Pb.05]. This indicates that the differences in mean scores between Time 1 and Time 2 and between Time 2 and Time 3 were significant for the intervention group but not for the control group. The Time 2 score was found to differ significantly from the Time 1 score for PAIS [ F(2, 101)=11.36; Pb.01] and for sleep [ F(2, 101)=15.14; Pb.001]. For perceived support, only the Time 1 and the Time 3 scores differed significantly [ F(2, 101)=14.30; Pb.0001]. Compliance with practicing thought monitoring and relaxation At Time 2, the mean home practice of relaxation with guided imagery was 3.4 (S.D.= 3.8) times per week; at Time 3, it was 2.3 (S.D.=2.9) times per week. Written thought monitoring was performed, on average, 2.7 (S.D.=2.5) times per week at Time 2 and 1.9 (S.D.=1.7) times per week at Time 3. At Time 3, women performed relaxation and guided imagery significantly more times per week (mean=3.8 times, S.D.=2.6) than men (mean=1.8 times, S.D.=2.0) (t=3.1, Pb.01). Thought monitoring was performed, on average, 2.3 (S.D.=1.7) times per week by men and 1.6 (S.D.=1.2) times per week by women, but the difference was not statistically significant. Regression analysis for the outcome variables Regression analysis was conducted on the total change in psychosocial variables at Time 3 for the intervention group (Table 4). Independent variables entered were sex, initial scores, time since diagnosis of the ill relative, and compliance at Time 3 with practice of thought monitoring and of relaxation/guided imagery. Higher GSI preintervention scores and higher compliance with thought monitoring and with relaxation/guided imagery were significant predictors of the total change in GSI. The independent variables accounted for 37% of the variance of GSI. The independent variables accounted for 45% of variance of sleep difficulties. Being male, scoring higher in preintervention, longer time since diagnosis, and complying more with both modalities were significant predictors. Thirty-five percent of the PAIS variance was accounted for by the dependent variables; of these, higher preintervention scores, longer time since diagnosis, and M. Cohen, A. Kuten / Journal of Psychosomatic Research 61 (2006) 187 – 196 Table 4 Multiple regression and analysis for mean total change in outcomes variables for the intervention group (n=52) Variable Total change – GSI Sex Preintervention score Time since relative’s diagnosis Compliance to thoughts monitoring Compliance to relaxation/imagery Total change–sleep difficulties Sex Preintervention score Time since relative’s diagnosis Compliance to thoughts monitoring Compliance to relaxation/imagery Total change –PAIS Sex Preintervention score Time since relative’s diagnosis Compliance to thoughts monitoring Compliance to relaxation/imagery Total change –perceived support Sex Preintervention score Time since relative’s diagnosis Compliance to thoughts monitoring Compliance to relaxation/imagery h R2 Adjusted R 2 .43 .37 .48 .45 .41 .35 .28 .26 .12 .38*** .16 .29** .24* .09 .36*** .28** .24* .28** .13 .35** .24* .27* .18 .23* .27* .09 .06 .10 * Pb.05. ** Pb.01. *** Pb.001. greater compliance were significant predictors of the change in PAIS scores. Twenty-six percent of the variance of perceived support was accounted for by the dependent variables, of which significant predictors of the change were only being male and having lower preintervention scores. Significance of change The RCI calculation (RCI= 6.5) showed a clinically significant improvement in psychological distress from preintervention to follow-up in 30.8% (n=16) of the participants in the intervention group, in contrast to that in only 3.9% (n=2) of the subjects in the control group. All participants who experienced significant change had initial GSI scores higher than the norm. The change in the other measured variables was also clinically significant for the intervention group (for PAIS, RCI=2.2; for sleep difficulties, RCI=14.8; for perceived support, RCI=3.2). Discussion This study evaluated the effectiveness of short-term CB group intervention with relatives of cancer patients receiving treatment for primary cancer. The results indicated the presence of an intervention effect for psychological distress, sleep difficulties, and psychological adjustment to illness. The effect was maintained over the 4-month follow-up. A 193 significant effect for perceived support was observed only on follow-up. Thirty percent of the participants in the intervention groups with high initial GSI scores achieved a clinically significant improvement. These results are of importance in light of the small overall number of controlled studies on interventions with relatives of cancer patients; these generally reported no change in psychological distress [16,17] or adjustment problems [15] as a result of the intervention. Our study is likewise especially significant considering the dearth of research evaluating CB interventions for relatives of cancer patients. High refusal and dropout rates in groups for cancer patients’ relatives were previously described [23]. However, the results are in line with previous reports on the positive effect of CB therapy for cancer patients (reviewed in Refs. [21,45,46]) and for other groups of distressed individuals [47– 49], although other studies reported no difference in outcomes of CB groups and various control groups [50]. The positive effect of the present CB group intervention suggests that this mode may be effective for relatives too. Most of the decreases in psychological distress and sleep difficulties were observed during the intervention period. The positive effect of CB interventions on psychological distress was previously widely studied and confirmed with different populations [21,45– 47]. The positive effect of CB interventions on sleep difficulties was only recently empirically confirmed [26,27], supporting the present findings. Reducing sleep difficulties may significantly improve positive coping with and adjustment to life stress, so it should be an important goal of interventions with relatives [26]. Although increasing the level of perceived support was among the main aims of the intervention, by its end, the change in perceived support was not significant. However, perception of support continued to improve in the intervention group and appeared significantly better in the follow-up as compared with the preintervention reports. Ogrodniczuk et al. [51] likewise found that changes in perceived support were evident only at the follow-up period of the group intervention, not immediately at the end of sessions. A possible explanation may lie in the nature of perceived support, which, in addition to being reactive to the situation of coping with cancer in a relative, carries elements of a core belief. Moorey and Greer [18] already suggested that core beliefs can be changed even in short-term CB interventions, but in a somewhat longer process and after a patient feels less distressed. In addition, a process of learning and assimilating the cognitive techniques may have to occur before the techniques can be implemented into actual coping and before they have a significant effect on perceptions such as social support. In addition, it could be that during the group sessions, support received from group members overshadowed support received from others, and only at follow-up was the change in the perception of support from family and significant others evident. In contrast to the intervention group, the control group showed no change and even a nonsignificant trend of 194 M. Cohen, A. Kuten / Journal of Psychosomatic Research 61 (2006) 187 – 196 deterioration in perceived support between the time points; this accords with the findings of previous studies indicating the growing sense of isolation among cancer patients and their relatives over time [52]. In line with previous studies [34,53], higher initial distress predicted higher total change in all outcome variables. In addition, being male predicted higher change in perceived support. The role of sex may be explained by the lower initial perceived support among the males and the positive relationship between lower initial scores and greater increase during the intervention and follow-up. Compliance with home practice of the cognitive and behavioral techniques learned in CB sessions was also a significant predictor of the total change in outcome variables. The role of such compliance was only seldom measured in past studies, which did not include this variable in the evaluation of outcomes [21,54,55]. The present results indicate that compliance was not very high and was even lower at follow-up. However, it was associated with the degree of improvement in the psychosocial variables; compliance with relaxation and guided imagery was associated with improvement in GSI scores and sleep difficulties, whereas compliance with automatic thought monitoring was associated with the degree of change in GSI and PAIS scores and sleep difficulties. On the other hand, increase in social support was not associated with frequency of practice. This finding also relates to the slower pattern of change in social support as compared with the other variables, which appeared after relief in psychological distress and assimilation of the new approach [18]. The measuring of compliance, which was based on selfreports of frequency of performance, had some drawbacks. This measure may have been liable to recall inaccuracy or to social desirability bias [56]. In addition, patients may have needed to use written monitoring less when they became more acquainted with the cognitive techniques. It is important to expand research on the effects of compliance with home practice on results of CB interventions using more accurate ways of measuring compliance. Writing a diary of compliance is a possibility, although it too has disadvantages such as being time consuming, requiring high commitment from participants, and involving problems ensuring validity. The effect of the intervention lasted for 4 months after it ended, which is in accordance with previous reports on CB interventions [45– 48], although other studies reported that the difference between intervention and control groups had diminished by the time of the follow-up [21]. The significance of the changes in outcome variables was examined using effect size and RCI. Effect size indicated a medium-to-high effectiveness of the CB intervention; RCI indicated a significant clinical change in 30.8% of the patients. The results are similar to those of other studies that measured the effect of CB group interventions [57]. Participants in the control group also showed a decrease in GSI scores over time, but only 3.9% showed a clinically significant improvement. Studies found RCI to be a more reliable indicator of treatment outcomes than other statistical measures [33,58]. RCI has not yet been used to measure the clinical significance of change in interventions with cancer patients and their relatives. Its significance and necessity in the realm of psycho-oncology should be further studied. Several limitations of our study need to be underscored. In the first place, we did not randomly assign participants to intervention and control groups. This was because all the relatives who were wished for CB intervention experienced some level of psychological stress and felt in need of immediate professional help. Ethically and professionally, we could not assign them to the control group and delay giving them professional help at precisely the time they needed it most. Note, however, that the intervention and control participants were equally anxious to take part in the intervention and that no demographic difference was found between them. Nevertheless, the possibility that those who moved to the control group were different in several respects cannot be ruled out. For example, the control subjects who wanted to participate in the intervention but were unable to do so for various reasons might have been less motivated to experience the intervention or had to cope with additional stresses and commitments in their lives. They perhaps had had less previous exposure to group interventions. However, the effect sizes and the RCI results indicate that the differences measured between the groups at Time 2 and Time 3 were apparently not caused by chance. Furthermore, a meta-analysis that compared psychotherapies for patients with schizophrenia found similar effect sizes for studies that used randomization and those that did not [59]. Another limitation of the study was the relatively small sample size, although it was similar to [53] or even higher than [21] the size used by other studies evaluating group interventions. Taking these limitations together, generalization from the present results to other groups of relatives should be done with caution. In conclusion, this study demonstrated the effectiveness of a CB group intervention in reducing psychological distress and increasing the psychosocial adjustment of relatives of cancer patients. 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