Oslo University Hospital
Oslo, 0407, Norway
NCT Number: NCT03022071
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Oslo, 0407, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Psychodynamic psychotherapy
Time frame: 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
Time frame: 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
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Assesment of dynamic 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)
Assessment of cognitive insight
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Assessment of global symptoms and functioning
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Measure of interpersonal problems
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Assessment of reflective 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)
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)
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)
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)
Measure of general Health issues
Time frame: Baseline (inclusion). Moderator of treatment
Measure of childhood trauma
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)
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)
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)
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)
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)
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)
Measure anxiety
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Measures hypomanic symptoms
Oslo University Hospital
Other
What Works for Whom and How? Mechanisms of Change in Psychotherapy
Acronym: MOP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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