Comparing Group Metacognitive Therapy to Clinical Management for Depression
A Randomized Controlled Trial of the Effectiveness of Group Metacognitive Therapy vs Clinical Management for Patients With Major Depressive Disorder
This study is testing if Group Metacognitive Therapy can help people with depression feel better compared to regular treatment options like guided self-help.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Oslo Academic / other |
| Locations | 1 site (Drammen, Buskerud) |
| Trial ID | NCT03711123 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Group Metacognitive Therapy (GMCT) in treating Major Depressive Disorder (MDD) compared to standard clinical management, which includes guided self-help. The research will explore patterns of change in depressive symptoms and identify factors that influence treatment outcomes, such as psychological variables and biomarkers like heart rate variability. Participants will be randomly assigned to either GMCT or clinical management, with the goal of determining which approach yields better recovery rates. The study is conducted in Norwegian and requires participants to provide informed consent before joining.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with Major Depressive Disorder who are stable on medication or medication-free.
Not a fit: Patients with underlying medical conditions, psychosis, or those currently undergoing other psychological treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from Major Depressive Disorder.
How similar studies have performed: Previous pilot studies have shown promising results for Metacognitive Therapy, suggesting potential effectiveness, but this study aims to provide more definitive evidence through a randomized controlled trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * alcohol/substance dependence/abuse * concurrent psychological treatment or evidence based psychotherapy for depression past year * bipolar disorder
Where this trial is running
Drammen, Buskerud
- Specialist practice Dr Toril Dammen — Drammen, Buskerud, Norway (Recruiting)
Study contacts
- Study coordinator: Toril Dammen, PhD
- Email: toril.dammen@medisin.uio.no
- Phone: 4790163433
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.