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Completed

NCT Number: NCT03022071

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0407, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Psychodynamic psychotherapy

Primary outcomes

  1. Hamilton Depression Rating Scale

    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

  2. Beck Depression Index

    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

Secondary outcomes

  1. Psychodynamic Functioning Scale

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

    Assesment of dynamic functioning

  2. Beck Cognitive Insight Score

    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

  3. Global Assesment of Functioning

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

    Assessment of global symptoms and functioning

  4. Inventory of Interpersonal Problems

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

    Measure of interpersonal problems

  5. Reflective functioning - depression

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

    Assessment of reflective functioning

  6. Dysfunctional Attitude Scale

    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

  7. Metacognitive questionnaire

    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

Other outcomes

  1. Work and Social Adjustment Scale

    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

  2. The Short Form Health Survey

    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

  3. Childhood Trauma Questionnaire

    Time frame: Baseline (inclusion). Moderator of treatment

    Measure of childhood trauma

  4. Severity of Indices of personality Problems

    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

  5. Toronto Alexithymia Scale

    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

  6. Rumination respons scale

    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

  7. Structural Analysis of 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)

    Measure social behavior

  8. Experience in Close Relationship Inventory

    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

  9. Patient Health questionnaire

    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

  10. Hypomani Checlist

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

    Measures hypomanic symptoms

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: MOP

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jan 16, 2017
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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