Mechanisms of Change in Psychotherapy

Not Applicable

Completed

• Conditions: Depression
• Interventions: Other: Cognitive behavior therapy

• Registration Number: NCT03022071
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Study Start: 2017-02-01
• Status Verified: 2021-09
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychodynamic psychotherapy	Cognitive behavior therapy	The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks.
Cognitive behavior therapy	Cognitive behavior therapy	The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Inventory of Interpersonal Problems	Change in scores during therapy and the follow-up periode (one and three years)	Measure of interpersonal problems
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
Psychodynamic Functioning Scale	Change in scores during therapy and the follow-up periode (one and three years)	Assesment of dynamic functioning
Global Assesment of Functioning	Change in scores during therapy and the follow-up periode (one and three years)	Assessment of global symptoms and functioning
Reflective functioning - depression	Change in scores during therapy and the follow-up periode (one and three years)	Assessment of reflective 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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway