DepressionMOPNCT03022071
Mechanisms of Change in Psychotherapy
A study testing Cognitive behavior therapy in people with Depression, run by Oslo University Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive behavior therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2017to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current or past neurological illness, traumatic brain injury, current alcohol and/or substance dependency disorders, psychotic disorders, developmental disorders, and mental retardation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Cognitive behavior therapy
- Keywords
- Cognitive behavior therapy, Psychodynamic therapy, Mediators, Moderators
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyOther
Also called Psychodynamic psychotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavior therapy | Experimental | The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks. Receives: Other: Cognitive behavior therapy |
| Psychodynamic psychotherapy | Active comparator | The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks. Receives: Other: Cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Assessment of depression
Measured: 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
Measured: 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
Assesment of dynamic functioning
Measured: Change in scores during therapy and the follow-up periode (one and three years)
Beck Cognitive Insight Score
Assessment of cognitive insight
Measured: 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
Measured: Change in scores during therapy and the follow-up periode (one and three years)
Inventory of Interpersonal Problems
Measure of interpersonal problems
Measured: Change in scores during therapy and the follow-up periode (one and three years)
Reflective functioning - depression
Assessment of reflective functioning
Measured: Change in scores during therapy and the follow-up periode (one and three years)
Dysfunctional Attitude Scale
Measure of dysfunctional attitude
Measured: 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
Measured: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Ivar Røssberg, MD, Oslo University Hospital
- Investigators
- Jan I Røssberg, phD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022071
- Sponsor's protocol ID
- What works for whom and how?
- Acronym
- MOP
- Status last verified
- Sep 2021
- First submitted
- 14 Nov 2016
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Torgersen K, Dammen T, Klungsoyr O, Wilberg T, Bringager CB, Horgen Evensen J, Lovgren A, Malkomsen A, Osnes K, Ulberg R, Rossberg JI. Improvement and deterioration trajectories in psychotherapy for depression: results from an RCT with cognitive behavioural and psychodynamic therapy. Nord J Psychiatry. 2026 May;80(4):209-218. doi: 10.1080/08039488.2026.2648291. Epub 2026 Mar 30.
PubMed 41910229Malkomsen 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.
PubMed 39934737Malkomsen 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.
PubMed 35761306Malkomsen 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.
PubMed 34706691Rossberg 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.
PubMed 33482927
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Works for Whom and How? Mechanisms of Change in Psychotherapy
- ClinicalTrials.gov ID
- NCT03022071
- Acronym / sponsor ID
- MOP / What works for whom and how?
- Conditions
- Depression
- Keywords
- Cognitive behavior therapy, Psychodynamic therapy, Mediators, Moderators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior therapy | Experimental | Other: Cognitive behavior therapyThe included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks. |
| Psychodynamic psychotherapy | Active comparator | Other: Cognitive behavior therapyThe included patients will receive time-limited psychodynamic psychotherapy for 28 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Current or past neurological illness, traumatic brain injury, current alcohol and/or substance dependency disorders, psychotic disorders, developmental disorders, and mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapyAlso: Psychodynamic psychotherapyIn 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 | Cognitive behavior therapy, Psychodynamic psychotherapy |
Primary outcome
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
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
7 secondary outcomes
Psychodynamic Functioning Scale
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
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)
Global Assesment of Functioning
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Inventory of Interpersonal Problems
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
Reflective functioning - depression
Time frame: Change in scores during therapy and the follow-up periode (one and three years)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 41910229Torgersen K, Dammen T, Klungsoyr O, Wilberg T, Bringager CB, Horgen Evensen J, Lovgren A, Malkomsen A, Osnes K, Ulberg R, Rossberg JI. Improvement and deterioration trajectories in psychotherapy for depression: results from an RCT with cognitive behavioural and psychodynamic therapy. Nord J Psychiatry. 2026 May;80(4):209-218. doi: 10.1080/08039488.2026.2648291. Epub 2026 Mar 30.
- Derived from this study: PubMed 39934737Malkomsen 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.
- Derived from this study: PubMed 35761306Malkomsen 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.
- Derived from this study: PubMed 34706691Malkomsen 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.
- Derived from this study: PubMed 33482927Rossberg 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.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan I Røssberg, phD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy in people with Depression, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022071, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.