Mechanisms of Change in Psychotherapy (MOP)

What Works for Whom and How? Mechanisms of Change in Psychotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Other: Cognitive behavior therapy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan I Røssberg, PhD; Phone Number: +47 47876866; Email: j.i.rossberg@medisin.uio.no
• Study Contact Backup: Name: Randi Ulberg, PhD; Phone Number: +47 95883479; Email: randi.ulberg@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Recruiting
    • Oslo University Hospital
    • Contact: Jan I Røssberg, PhD; Phone Number: +47 47876866; Email: j.i.rossberg@medisin.uio.no
    • Contact: Randi Ulberg, PhD; Phone Number: +47 95883479; Email: randi.ulberg@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavior therapy; The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 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.; Other Names: Psychodynamic psychotherapy
Active Comparator: Psychodynamic psychotherapy; 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.; Other Names: Psychodynamic psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Jan I Røssberg, phD, Oslo University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cognitive behavior therapy; Psychodynamic therapy; Mediators; Moderators
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: What works for whom and how?

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No