Mechanisms of Change in Psychotherapy (MOP)
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavior therapy
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Cognitive behavior therapy, Psychodynamic therapy, Mediators, Moderators
Eligibility Criteria
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.
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive behavior therapy
Psychodynamic psychotherapy
Arm Description
The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks.
The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks.
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale
Assessment of depression
Beck Depression Index
Assessment of depression
Secondary Outcome Measures
Psychodynamic Functioning Scale
Assesment of dynamic functioning
Beck Cognitive Insight Score
Assessment of cognitive insight
Global Assesment of Functioning
Assessment of global symptoms and functioning
Inventory of Interpersonal Problems
Measure of interpersonal problems
Reflective functioning - depression
Assessment of reflective functioning
Dysfunctional Attitude Scale
Measure of dysfunctional attitude
Metacognitive questionnaire
Assessments of metacognition
Full Information
NCT ID
NCT03022071
First Posted
November 14, 2016
Last Updated
September 8, 2021
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03022071
Brief Title
Mechanisms of Change in Psychotherapy
Acronym
MOP
Official Title
What Works for Whom and How? Mechanisms of Change in Psychotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Cognitive behavior therapy, Psychodynamic therapy, Mediators, Moderators
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study we want to examine moderators and mediators in two equally effective, well known psychotherapeutic treatments (Psychodynamic and cognitive behavior therapy)
Masking
Outcomes Assessor
Masking Description
Outcome assessments will be provided by raters blinded to the randomization
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavior therapy
Arm Type
Experimental
Arm Description
The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks.
Arm Title
Psychodynamic psychotherapy
Arm Type
Active Comparator
Arm Description
The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks.
Intervention Type
Other
Intervention Name(s)
Cognitive behavior therapy
Other Intervention Name(s)
Psychodynamic psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
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
Title
Beck Depression Index
Description
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
Secondary Outcome Measure Information:
Title
Psychodynamic Functioning Scale
Description
Assesment of dynamic functioning
Time Frame
Change in scores during therapy and the follow-up periode (one and three years)
Title
Beck Cognitive Insight Score
Description
Assessment of cognitive insight
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)
Title
Global Assesment of Functioning
Description
Assessment of global symptoms and functioning
Time Frame
Change in scores during therapy and the follow-up periode (one and three years)
Title
Inventory of Interpersonal Problems
Description
Measure of interpersonal problems
Time Frame
Change in scores during therapy and the follow-up periode (one and three years)
Title
Reflective functioning - depression
Description
Assessment of reflective functioning
Time Frame
Change in scores during therapy and the follow-up periode (one and three years)
Title
Dysfunctional Attitude Scale
Description
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)
Title
Metacognitive questionnaire
Description
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)
Other Pre-specified Outcome Measures:
Title
Work and Social Adjustment Scale
Description
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)
Title
The Short Form Health Survey
Description
Measure of general Health issues
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)
Title
Childhood Trauma Questionnaire
Description
Measure of childhood trauma
Time Frame
Baseline (inclusion). Moderator of treatment
Title
Severity of Indices of personality Problems
Description
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)
Title
Toronto Alexithymia Scale
Description
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)
Title
Rumination respons scale
Description
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)
Title
Structural Analysis of Social Behavior
Description
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)
Title
Experience in Close Relationship Inventory
Description
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)
Title
Patient Health questionnaire
Description
Measure anxiety
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)
Title
Hypomani Checlist
Description
Measures hypomanic symptoms
Time Frame
Change in scores during therapy and the follow-up periode (one and three years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan I Røssberg, PhD
Phone
+47 47876866
Email
j.i.rossberg@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Randi Ulberg, PhD
Phone
+47 95883479
Email
randi.ulberg@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan I Røssberg, phD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan I Røssberg, PhD
Phone
+47 47876866
Email
j.i.rossberg@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
Randi Ulberg, PhD
Phone
+47 95883479
Email
randi.ulberg@medisin.uio.no
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
35761306
Citation
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.
Results Reference
derived
PubMed Identifier
34706691
Citation
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.
Results Reference
derived
PubMed Identifier
33482927
Citation
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.
Results Reference
derived
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Mechanisms of Change in Psychotherapy
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