RCT studie Psykiatriska kliniken

Randomized trial of treatment of
depression with Interpersonal
psychotherapy and Cognitive Behavioural
Therapy
Psychiatric clinic, Hospital of Sundsvall
Västernorrland
Linköpings universitet
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Depression
• Depression is a common mental disorder that
presents with depressed mood, loss of interest or
pleasure, feelings of guilt and low self-worth,
disturbed sleep or appetite, low energy and poor
concentration
• At its worst, depression can lead to suicide,
associated with the loss of about 850 000 lives every
year (WHO)
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Depression
• Depression is the leading cause of disability as
measured by YLDs (WHO)
• By the year 2020, depression is projected to reach
2nd place among DALYs calculated for all ages, for
both sexes. Today, depression is the second cause of
DALYs in the age category 15-44 for both sexes
combined (WHO)
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Depression Sweden
• The Lundby study: 27 % men and 45 % women had
at least one episode of depression before the age of
70
• The incidence in Sweden is between 4 och 10 %
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National Board of Health and
Welfare, Sweden
• In the guidelines from National Board of Health and
Welfare in Sweden, CBT and IPT are recommended
as first hand choices for treatment of mild and
moderate depression. This recommendation is based
on studies from other countries. Comparative
randomized studies of CBT and IPT have not been
published in Sweden
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Randomized trial of treatment of depression with
Interpersonal psychotherapy and Cognitive
Behavioural Therapy
•
In all, 96 patients will take part in the study, during 2 years.
Inclusion
• Patients who seek treatment with a diagnosis of Major Depressive Disorder
(MDD), and who indicate mild or moderate depression on Beck’s Depression
Inventory will be asked to participate
Exclusion
• Exclusion criteria are psychosis, ongoing drug abuse, serious neuropsychiatric
disorder, personality disorder cluster B. We will also exclude patients who have
used disability pension and only include patients who have sickness benefit, as
psychotherapy with 16 sessions is unlikely to be enough to benefit patients with
disability pension.
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Background
• Both CBT and IPT are manualized short term
therapies but with different theoretical background
• Neither CBT nor IPT, using face-to-face treatment,
have been studied as treatments for depression in
RCTs in Sweden
• Outcome measured as work performance has not
been studied with these treatments.
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Hypothesis
• The main hypotheses in this study is that CBT and IPT are both
effective treatments for Major Depressive Disorder, and that
they have equal effects with regard to remission from
depression
• A second hypothesis is that CBT is more effective than IPT
when return to employment is the outcome measure
• Three moderator hypotheses will be tested (next slide)
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Three moderator hypotheses will
be tested
• The first moderator hypothesis is that patients with avoidant
attachment style get better results with CBT, whereas
patients with anxious attachment style get better results with
IPT
• The second hypothesis is that patients with higher Reflective
Function get better results with IPT than with CBT
• The third moderator hypothesis is that women respond
better to IPT and men to CBT, particularly if relational
functioning is considered. In the moderator hypotheses, both
remission from depression and return to work will be
outcome criteria
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The following instruments will be
used before and after treatment:
• Structured Clinical Interview for DSM-IV, I and II,
(SCID I (A) and II (after screening); First et al., 1999)
• Self-rating questionnaire from the Social Insurance
Agency for measuring work capacity and presence at
the work place (Undersökning om hälsa.
Enkätundersökning 2008. Försäkringskassan)
• MADRS ( Montgomery SA & Åsberg M. Br J
Psychiatry 1979; 134:382-9)
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Measurements, cont
• Alcohol Use Disorders Identification test (Audit;
Babor, Higgins-Biddle, Saunders & Monteiro, 2001)
• Adult Attachment Interview (AAI; 11 questions for
measuring Reflective function, Main, Caplan &
Cassidy, 1985), combined with
• Sheehan Disability Scale (Sheehan, Harnett-Sheehan
& Raj, 1996)
• Beck Anxiety Inventory (BAI) Beck, Epstein, Brown &
Steer, 1988)
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Before and after treatment, and after
session five, the following instruments will
be used:
• Depressive Experiences Questionnaire (DEQ; Blatt,
D'Afflitti & Quinlan, 1976)
• Experiences in Close Relationships-revised (ECR-R,
Brennan, 1998; Broberg & Zahr, 2003)
• Trail Making Test, TMT A och B Delis-Kaplan
Executive Function System, D-KEFS (Delis, Kaplan &
Kramer, 2001).
• Controlled Oral Word Association Test (COWAT;
Benton, Hamsher & Sivan, 1976)
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Before and after treatment, and after session
five, the following instruments will be used,
cont:
• Perceived Social Support Questionnaire (PSS;
Procidano & Heller, 1983, translated to Swedish by
Ghaderi och Scott, 1997)
• The interview: The Depression Specific Reflective
Function Interview (DSRF, modified after Rudden,
2007), specially adapted for depressive symptoms
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Mesurements, cont
Before each session (patient):
• Becks Depression Inventory (BDI 2) (Beck, Steer &
Brown, 1996)
After each session (patient and therapist):
• Working alliance Inventory, short version (WAI;
Horvath, 2001)
• Feeling Checklist (Holmqvist & Armelius, 1994)
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Adherence
• All sessions are videotaped
• A number of therapy sessions from each therapist
will be rated to ascertain treatment integrity
• The Collaborative Study Psychotherapy Rating Scale6 (CSPRS-6; Markowitz, Spielman, Scarvalone &
Perry, 2000), which is the standard scale for rating
adherence to CBT and IPT, will be used
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Ethical considerations
• Ethical approvement has been given by the ethical
committee at Linköping University. Patients who do
not want to take part in the study will be offered
adequate treatment.
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Some preliminary results
• RF/ mentalizing in depression
• Some characteristics of included patients
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Discussion
• The Allegiance problem – Which therapy is best liked by the
researchers and the therapists?
• The Therapy process – is there a balance to be struck
between adherence to the manual and adaptation to the
patient’s responsiveness?
• It is not easy to get the therapists participating – ideas?
• Outcome measured as work performance has not been
studied with these treatments, (workcapacity not often used
as measurement)
• Medication with SSRI?
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