Major Depressive DisorderNCT03711123
Group Metacognitive Therapy vs Clinical Management for Depression
A study testing Group metacognitive therapy and Clinical management in people with Major Depressive Disorder, run by University of Oslo at 1 site in Norway.
Trial summary
The main aims of the study are to (1) compare the effectiveness of Group metacognitive therapy (GMCT) treatment to that of clinical management and (2) explore patterns of change and investigate factors associated with treatment outcome Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Group metacognitive therapy and Clinical management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2018to Jun 2025
- 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
- MDD is primary problem
- 18-65 years
- stable on medication for at least 8 weeks or medication free
- able to understand and write the Norwegian Language
- signed written informed consent prior to participation
Who cannot join
- Medical or physical condition underlying depression
- psychosis or organic mental illness
- current suicide intent
- not willing to Accept no changes in medication during treatment
- not willing to Accept random allocation
- cluster A or cluster B personality disorder
Show all 9Show fewer
- alcohol/substance dependence/abuse
- concurrent psychological treatment or evidence based psychotherapy for depression past year
- bipolar disorder
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Specialist practice Dr Toril Dammen
Drammen, Buskerud, 3014
Toril Dammen, PhD, 4790163433, toril.dammen@medisin.uio.no
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of Group Metacognitive Therapy vs Clinical Management for Patients With Major Depressive Disorder
The main aims of the study are to (1) compare the effectiveness of Group metacognitive therapy (GMCT) treatment to that of clinical management and (2) explore patterns of change and investigate factors associated with treatment outcome
Read the detailed description
Major depressive disorder (MDD) is a disabling condition which adversely affects a person's family, work or school life, sleeping and eating habits, and general health.
Cognitive-behavioral therapy (CBT) is a well established effective recommended treatment for MDD. However, only 40-58 % of patients receiving CBT may be classified as recovered using clinical significant change assessed by the Beck Depression Inventory and only between one-third and one quarter of patients receiving CBT remain recovered 18 months after treatment.
A new treatment approach to MDD is Metacognitive Therapy (MCT). In this treatment approach, MDD is conceptualized as being maintained by rumination and meta-cognitions. Treatment seeks to challenge and change specific meta-cognitions and rumination, through behavioural experiments and verbal reattribution. There is accumulating evidence that MCT is effective in the treatment of depression, both individualized and in Groups. A recent pilot study indicated effectiveness above that of CBT. However, the results need to be tested in a randomized controlled trial with a larger sample of patients and a comparison group of active treatment.
The purpose of this trial is to evaluate the effectiveness of Group MCT treatment compared to clinical management included guided self-help and to explore which factors that are associated with depressive symptom outcome in terms of psychological factors, biomarker in terms of heart rate variabilities and polygenic risk score.
The study will be a randomized controlled, trial comprising 64 patients with a primary diagnosis of major depressive disorder (DSM-IV; American Psychiatric Association (APA), 1994). Experienced diagnosticians will assess all patients by using structural interviews such as Structured Clinical Interview for DSM-IV, axis I(SCID I), and axis II disorders (SCID II) and the Hamilton Rating Scale for Depression (HDRS).
All patients will be randomized in blocks to two groups in order to compare the following conditions: Group MCT of 10 weekly sessions lasting 90 minutes and a clinical management condition With 10 weekly individualized sessions up to 60 minutes duration.
Both between-subjects and within-subjects comparisons will be conducted. The research trial will be conducted at an outpatient specialist practice in Drammen, Norway.
The treatment will be administered according to the originators published treatment protocols for MCT for depression. Independent assessors will assess adherence and quality of treatment.
Independent experts will assess the quality of treatment by inspection of a sampling of video-recorded treatments. Using checklists session-by-session will ensure adherence of the therapy. Responsible investigator and supervisors will be using video of all treatment sessions to assess adherence to the treatment condition.
All patients referred for the study will be consecutively assessed at intake (SCID-I + II, HDRS-17). Based on diagnosis and criteria for inclusion and exclusion, the patients will be asked to volunteer to participate in the study and confirm by signing a form of consent.
Patients will be randomized to one of two conditions. Patients will be asked to self-rate symptoms on a battery of self-report questionnaires.
The patients will be assessed prior to treatment, by 10 weeks in treatment, and at six months and at one and two years of follow-up.
Reassessment of the diagnosis and symptom severity is made by post-treatment.
Criteria for recovery will be: Jacobsen criteria of a minimum change and patients crossing the cut-off point on two measures: The HDRS-17 and Beck Depression Inventory (BDI). Other outcome measures will include:
Reduction of depressive symptoms as measured by self-report questionnaires Number of patients with no MDD diagnosis based on SCID-I after treatment Relapse rate during six months and at one and two years follow-up The proportion of responders as measured by the HDRS-17 and BDI and those who no longer fulfil the conditions for a MDD diagnosis after 10 weeks (post-treatment) and by 6 months and one and two years follow-up.
The secondary efficacy variables will be the proportion of responders at 10 weeks (post-treatment) and six months and by one and two years follow-up as measured by the other symptom measures.
A comparison between the two groups of patients will be conducted at 10 weeks (post-treatment) and there will be 6 month and at one- and two years.
A within group analyses will be conducted in order to estimate effect sizes and significant clinical change estimates.
A computer provided by University of Oslo (UiO) will generate the randomization list.
- Conditions
- Major Depressive Disorder
- Being tested
- Group metacognitive therapy, Clinical management
- Keywords
- metacognitive therapy, psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group metacognitive therapyBehavioural
10 weekly Group session of 90 minutes duration
Clinical managementBehavioural
10 weekly individual sessions With clinical management including guided self-help
| Study group | Role | What they receive |
|---|---|---|
| Group metacognitive therapy (GMCT) | Experimental | 10 weekly sessions of GMCT With 90 minutes duration Receives: Behavioral: Group metacognitive therapy |
| Clinical Management | Active comparator | 10 weekly individual sessions with up to 60 minutes duration Receives: Behavioral: Clinical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
Beck Depression Inventory
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in diagnosis
SCID-I
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in depression
Hamilton Depression Rating Scale 17-item version (HDRS-17) yielding total scores from 0 (least severe) to 52 (most severe)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Secondary outcomes (11)
Change in rumination
Ruminative Responses Scale (RRS)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in positive beliefs
Positive Beliefs about rumination scale (PBRS)
Measured: baseline to 10 weeks, 6 months, 12 months and 24 months follow up
Change in Negative beliefs
Negative beliefs about rumination scale (NBRS)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in metacognitions
Metacognitions questionnaire-30 (MCQ-30)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in personality
Distressed type personality (DS-14)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in dysfunctional attitudes and beliefs
Dysfunctional attitude scales (DAS)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in resilience
Resilience Scale for adults (RSA)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in anxiety
Beck Anxiety Inventory (BAI)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in sleep
Pittsburgh sleep quality inventory (PSQI)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
change in report of executive function
Behaviour Rating of Executive Function (BRIEF-A)
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
change in personality diagnoses
SCID-II
Measured: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toril Dammen, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711123
- Sponsor's protocol ID
- 2015/673-1
- Status last verified
- Oct 2018
- First submitted
- 16 Apr 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of Group Metacognitive Therapy vs Clinical Management for Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03711123
- Acronym / sponsor ID
- 2015/673-1
- Conditions
- Major Depressive Disorder
- Keywords
- metacognitive therapy, psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Oct 2018 (actual)
- 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.
The main aims of the study are to (1) compare the effectiveness of Group metacognitive therapy (GMCT) treatment to that of clinical management and (2) explore patterns of change and investigate factors associated with treatment outcome
Detailed description
Major depressive disorder (MDD) is a disabling condition which adversely affects a person's family, work or school life, sleeping and eating habits, and general health.
Cognitive-behavioral therapy (CBT) is a well established effective recommended treatment for MDD. However, only 40-58 % of patients receiving CBT may be classified as recovered using clinical significant change assessed by the Beck Depression Inventory and only between one-third and one quarter of patients receiving CBT remain recovered 18 months after treatment.
A new treatment approach to MDD is Metacognitive Therapy (MCT). In this treatment approach, MDD is conceptualized as being maintained by rumination and meta-cognitions. Treatment seeks to challenge and change specific meta-cognitions and rumination, through behavioural experiments and verbal reattribution. There is accumulating evidence that MCT is effective in the treatment of depression, both individualized and in Groups. A recent pilot study indicated effectiveness above that of CBT. However, the results need to be tested in a randomized controlled trial with a larger sample of patients and a comparison group of active treatment.
The purpose of this trial is to evaluate the effectiveness of Group MCT treatment compared to clinical management included guided self-help and to explore which factors that are associated with depressive symptom outcome in terms of psychological factors, biomarker in terms of heart rate variabilities and polygenic risk score.
The study will be a randomized controlled, trial comprising 64 patients with a primary diagnosis of major depressive disorder (DSM-IV; American Psychiatric Association (APA), 1994). Experienced diagnosticians will assess all patients by using structural interviews such as Structured Clinical Interview for DSM-IV, axis I(SCID I), and axis II disorders (SCID II) and the Hamilton Rating Scale for Depression (HDRS).
All patients will be randomized in blocks to two groups in order to compare the following conditions: Group MCT of 10 weekly sessions lasting 90 minutes and a clinical management condition With 10 weekly individualized sessions up to 60 minutes duration.
Both between-subjects and within-subjects comparisons will be conducted. The research trial will be conducted at an outpatient specialist practice in Drammen, Norway.
The treatment will be administered according to the originators published treatment protocols for MCT for depression. Independent assessors will assess adherence and quality of treatment.
Independent experts will assess the quality of treatment by inspection of a sampling of video-recorded treatments. Using checklists session-by-session will ensure adherence of the therapy. Responsible investigator and supervisors will be using video of all treatment sessions to assess adherence to the treatment condition.
All patients referred for the study will be consecutively assessed at intake (SCID-I + II, HDRS-17). Based on diagnosis and criteria for inclusion and exclusion, the patients will be asked to volunteer to participate in the study and confirm by signing a form of consent.
Patients will be randomized to one of two conditions. Patients will be asked to self-rate symptoms on a battery of self-report questionnaires.
The patients will be assessed prior to treatment, by 10 weeks in treatment, and at six months and at one and two years of follow-up.
Reassessment of the diagnosis and symptom severity is made by post-treatment.
Criteria for recovery will be: Jacobsen criteria of a minimum change and patients crossing the cut-off point on two measures: The HDRS-17 and Beck Depression Inventory (BDI). Other outcome measures will include:
Reduction of depressive symptoms as measured by self-report questionnaires Number of patients with no MDD diagnosis based on SCID-I after treatment Relapse rate during six months and at one and two years follow-up The proportion of responders as measured by the HDRS-17 and BDI and those who no longer fulfil the conditions for a MDD diagnosis after 10 weeks (post-treatment) and by 6 months and one and two years follow-up.
The secondary efficacy variables will be the proportion of responders at 10 weeks (post-treatment) and six months and by one and two years follow-up as measured by the other symptom measures.
A comparison between the two groups of patients will be conducted at 10 weeks (post-treatment) and there will be 6 month and at one- and two years.
A within group analyses will be conducted in order to estimate effect sizes and significant clinical change estimates.
A computer provided by University of Oslo (UiO) will generate the randomization list.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group metacognitive therapy (GMCT) | Experimental | Behavioral: Group metacognitive therapy10 weekly sessions of GMCT With 90 minutes duration |
| Clinical Management | Active comparator | Behavioral: Clinical management10 weekly individual sessions with up to 60 minutes duration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- MDD is primary problem
- 18-65 years
- stable on medication for at least 8 weeks or medication free
- able to understand and write the Norwegian Language
- signed written informed consent prior to participation
Key exclusion criteria (9 listed)
- Medical or physical condition underlying depression
- psychosis or organic mental illness
- current suicide intent
- not willing to Accept no changes in medication during treatment
- not willing to Accept random allocation
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 |
|---|---|---|
| Group metacognitive therapy10 weekly Group session of 90 minutes duration | Behavioural | Group metacognitive therapy (GMCT) |
| Clinical management10 weekly individual sessions With clinical management including guided self-help | Behavioural | Clinical Management |
Primary outcome
Change in depression
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Beck Depression Inventory
Change in diagnosis
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
SCID-I
Change in depression
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Hamilton Depression Rating Scale 17-item version (HDRS-17) yielding total scores from 0 (least severe) to 52 (most severe)
11 secondary outcomes
Change in rumination
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in positive beliefs
Time frame: baseline to 10 weeks, 6 months, 12 months and 24 months follow up
Change in Negative beliefs
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in metacognitions
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in personality
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in dysfunctional attitudes and beliefs
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in resilience
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in anxiety
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Change in sleep
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
change in report of executive function
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
change in personality diagnoses
Time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group metacognitive therapy and Clinical management in people with Major Depressive Disorder, run by University of Oslo 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Toril Dammen, PhD (4790163433, toril.dammen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2018.