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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavior therapy | Experimental | The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks. |
|
| Psychodynamic psychotherapy | Active Comparator | The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavior therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale | Assessment of depression | Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up |
| Beck Depression Index | Assessment of depression | Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Psychodynamic Functioning Scale | Assesment of dynamic functioning | Change in scores during therapy and the follow-up periode (one and three years) |
| Beck Cognitive Insight Score | Assessment of cognitive insight |
| Measure | Description | Time Frame |
|---|---|---|
| Work and Social Adjustment Scale | Assessment of functioning | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| The Short Form Health Survey |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan I Røssberg, phD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41910229 | Derived | Torgersen K, Dammen T, Klungsoyr O, Wilberg T, Bringager CB, Horgen Evensen J, Lovgren A, Malkomsen A, Osnes K, Ulberg R, Rossberg JI. Improvement and deterioration trajectories in psychotherapy for depression: results from an RCT with cognitive behavioural and psychodynamic therapy. Nord J Psychiatry. 2026 May;80(4):209-218. doi: 10.1080/08039488.2026.2648291. Epub 2026 Mar 30. | |
| 39934737 |
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The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D064889 | Psychotherapy, Psychodynamic |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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In this study we want to examine moderators and mediators in two equally effective, well known psychotherapeutic treatments (Psychodynamic and cognitive behavior therapy)
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Outcome assessments will be provided by raters blinded to the randomization
|
|
| Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| Global Assesment of Functioning | Assessment of global symptoms and functioning | Change in scores during therapy and the follow-up periode (one and three years) |
| Inventory of Interpersonal Problems | Measure of interpersonal problems | Change in scores during therapy and the follow-up periode (one and three years) |
| Reflective functioning - depression | Assessment of reflective functioning | Change in scores during therapy and the follow-up periode (one and three years) |
| Dysfunctional Attitude Scale | Measure of dysfunctional attitude | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| Metacognitive questionnaire | Assessments of metacognition | 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
| Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| Childhood Trauma Questionnaire | Measure of childhood trauma | Baseline (inclusion). Moderator of treatment |
| Severity of Indices of personality Problems | Assessments of personality dimensions | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| Toronto Alexithymia Scale | Measures of alexithymia | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| Rumination respons scale | Measures of ruminations | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| Structural Analysis of Social Behavior | Measure 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) |
| Experience in Close Relationship Inventory | Functioning in Close relations | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| Patient Health questionnaire | Measure anxiety | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) |
| Hypomani Checlist | Measures hypomanic symptoms | Change in scores during therapy and the follow-up periode (one and three years) |
| Derived |
| Malkomsen A, Wilberg T, Bull-Hansen B, Dammen T, Evensen JH, Hummelen B, Lovgren A, Osnes K, Ulberg R, Rossberg JI. Comparative effectiveness of short-term psychodynamic psychotherapy and cognitive behavioral therapy for major depression in psychiatric outpatient clinics: a randomized controlled trial. BMC Psychiatry. 2025 Feb 11;25(1):113. doi: 10.1186/s12888-025-06544-6. |
| 35761306 | Derived | Malkomsen A, Rossberg JI, Dammen T, Wilberg T, Lovgren A, Ulberg R, Evensen J. How therapists in cognitive behavioral and psychodynamic therapy reflect upon the use of metaphors in therapy: a qualitative study. BMC Psychiatry. 2022 Jun 27;22(1):433. doi: 10.1186/s12888-022-04083-y. |
| 34706691 | Derived | Malkomsen A, Rossberg JI, Dammen T, Wilberg T, Lovgren A, Ulberg R, Evensen J. Digging down or scratching the surface: how patients use metaphors to describe their experiences of psychotherapy. BMC Psychiatry. 2021 Oct 27;21(1):533. doi: 10.1186/s12888-021-03551-1. |
| 33482927 | Derived | Rossberg JI, Evensen J, Dammen T, Wilberg T, Klungsoyr O, Jones M, Boen E, Egeland R, Breivik R, Lovgren A, Ulberg R. Mechanisms of change and heterogeneous treatment effects in psychodynamic and cognitive behavioural therapy for patients with depressive disorder: a randomized controlled trial. BMC Psychol. 2021 Jan 22;9(1):11. doi: 10.1186/s40359-021-00517-6. |