Mechanisms of Change in Psychotherapy

NCT03022071 | Completed

• 1 other identifier: What works for whom and how?
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Cognitive behavior therapy; Psychodynamic therapy; Mediators; Moderators

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Psychodynamic Functioning Scale

  Change in scores during therapy and the follow-up periode (one and three years)

• 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)

• Global Assesment of Functioning

  Change in scores during therapy and the follow-up periode (one and three years)

• Inventory of Interpersonal Problems

  Change in scores during therapy and the follow-up periode (one and three years)

• Reflective functioning - depression

  Change in scores during therapy and the follow-up periode (one and three years)

Other Outcomes (10)

• 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)

• 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)

• Childhood Trauma Questionnaire

  Baseline (inclusion). Moderator of treatment

Study Arms (2)

Cognitive behavior therapy

EXPERIMENTAL

The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks.

Other: Cognitive behavior therapy

Psychodynamic psychotherapy

ACTIVE COMPARATOR

The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks.

Other: Cognitive behavior therapy

Interventions

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.

Also known as: Psychodynamic psychotherapy

Cognitive behavior therapy; Psychodynamic psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current or past neurological illness, traumatic brain injury, current alcohol and/or substance dependency disorders, psychotic disorders, developmental disorders, and mental retardation.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0407, Norway

Location

Related Publications (4)

• 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.

  PMID: 39934737 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.

  PMID: 35761306 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.

  PMID: 34706691 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.

  PMID: 33482927 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy; Psychotherapy, Psychodynamic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jan I Røssberg, phD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be provided by raters blinded to the randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD PhD

Model Details: In this study we want to examine moderators and mediators in two equally effective, well known psychotherapeutic treatments (Psychodynamic and cognitive behavior therapy)

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: January 16, 2017
• Study Start: February 1, 2017
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 20, 2025

Record last verified: 2021-09

Locations

NO (1)