MOP: Mechanisms of Change in Psychotherapy
Study Details
Study Description
Brief Summary
Background: Major depressive disorder (MDD) is a prevalent psychiatric condition associated with significant disability, mortality and economic burden. MDD is ranked fourth in terms of disease burden as defined by the World Health Organization (2001). Cognitive Behavioral Therapy (CBT) and Psychodynamic Psychotherapy (PDT) are found to be equally effective for patients with depression. However, many patients do not respond sufficiently to treatment and relapse rates are high. To be able to offer individualized treatment, a clinically important question is therefore whether some patients profit more from one of the two therapies. At present little is known on which patient characteristics (moderators) may be associated with differential outcomes of CBT and PDT and through what kind of therapeutic processes and mechanisms (mediators) improvements occur in each therapy mode. There are actually only theoretical assumptions sparsely supported by research findings on what moderates and mediates the treatment effects of CBT and PDT.
Aims: The overall aim of this project is to examine putative moderators and mediators in CBT and PDT and develop more basic knowledge about their impact on outcomes of psychotherapy for patients with MDD.
Methods and study design: The study is a randomized clinical trial. One hundred patients will be randomized to one of two treatment conditions. The patients will be treated over 28 weeks with either CBT (one weekly session over 16 weeks and 3 booster sessions (monthly) during the rest of the 28 week study period) or PDT (one weekly session in 28 weeks). The patients will be evaluated at baseline, during therapy, at the end of therapy, and at follow-up investigations 1 and 3 years after treatment termination. The outcome measures comprise a large range of clinical and process variables, including assessment tools measuring specific preselected putative moderators and mediators.
Discussion: The clinical outcome of this trial may guide clinicians to decide what kind of treatment should be offered the individual patient. Moreover, it will shed light on what kind of mechanisms in psychotherapy that is followed by symptom improvement and increased psychosocial functioning.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cognitive behavior therapy The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks. |
Other: Cognitive behavior therapy
In this study we want to compare CBT and PDT and examine whether some patients will benefit from CBT and other from PDT. More specifically we want to examine moderators and mediators for improvement in depressive symptoms in the two interventions arms.
Other Names:
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| Active Comparator: Psychodynamic psychotherapy The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks. |
Other: Cognitive behavior therapy
In this study we want to compare CBT and PDT and examine whether some patients will benefit from CBT and other from PDT. More specifically we want to examine moderators and mediators for improvement in depressive symptoms in the two interventions arms.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Hamilton Depression Rating Scale [Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up]
Assessment of depression
- Beck Depression Index [Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up]
Assessment of depression
Secondary Outcome Measures
- Psychodynamic Functioning Scale [Change in scores during therapy and the follow-up periode (one and three years)]
Assesment of dynamic functioning
- Beck Cognitive Insight Score [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Assessment of cognitive insight
- Global Assesment of Functioning [Change in scores during therapy and the follow-up periode (one and three years)]
Assessment of global symptoms and functioning
- Inventory of Interpersonal Problems [Change in scores during therapy and the follow-up periode (one and three years)]
Measure of interpersonal problems
- Reflective functioning - depression [Change in scores during therapy and the follow-up periode (one and three years)]
Assessment of reflective functioning
- Dysfunctional Attitude Scale [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Measure of dysfunctional attitude
- Metacognitive questionnaire [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Assessments of metacognition
Other Outcome Measures
- Work and Social Adjustment Scale [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Assessment of functioning
- The Short Form Health Survey [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Measure of general Health issues
- Childhood Trauma Questionnaire [Baseline (inclusion). Moderator of treatment]
Measure of childhood trauma
- Severity of Indices of personality Problems [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Assessments of personality dimensions
- Toronto Alexithymia Scale [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Measures of alexithymia
- Rumination respons scale [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Measures of ruminations
- Structural Analysis of Social Behavior [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Measure social behavior
- Experience in Close Relationship Inventory [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Functioning in Close relations
- Patient Health questionnaire [Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)]
Measure anxiety
- Hypomani Checlist [Change in scores during therapy and the follow-up periode (one and three years)]
Measures hypomanic symptoms
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged between 18-65 years, with depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV; American Psychiatric Association, 2000) unipolar MDD diagnosis will be included.MINI plus (Sheehan et al., 1998 will be used as assessment tool. Comorbidity is expected to be frequent. Written consent will be obtained from all patients.
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The participants need to have the ability to speak and understand a Scandinavian language, and willingness and ability to give informed consent.
Exclusion Criteria:
- Current or past neurological illness, traumatic brain injury, current alcohol and/or substance dependency disorders, psychotic disorders, developmental disorders, and mental retardation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oslo University Hospital | Oslo | Norway | 0407 |
Sponsors and Collaborators
- Oslo University Hospital
Investigators
- Principal Investigator: Jan I Røssberg, phD, Oslo University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- What works for whom and how?