An interventional study of Cognitive behavior therapy in Depression, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 100 is above the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks.
Other: Cognitive behavior therapy
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.
Also known as: Psychodynamic psychotherapy
Hamilton Depression Rating Scale
Assessment of depression
Time frame: 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
Time frame: Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up
Psychodynamic Functioning Scale
Assesment of dynamic functioning
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Beck Cognitive Insight Score
Assessment of cognitive insight
Time frame: 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
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Inventory of Interpersonal Problems
Measure of interpersonal problems
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Reflective functioning - depression
Assessment of reflective functioning
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Dysfunctional Attitude Scale
Measure of dysfunctional attitude
Time frame: 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
Time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Work and Social Adjustment Scale
Assessment of functioning
Time frame: 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
Measure of general Health issues
Time frame: 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
Time frame: Baseline (inclusion). Moderator of treatment
Severity of Indices of personality Problems
Assessments of personality dimensions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Plan to share: Undecided — The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital