NCT03711123

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2.4 years

First QC Date

April 16, 2018

Last Update Submit

October 16, 2018

Conditions

Major Depressive Disorder

Keywords

metacognitive therapy, psychotherapy

Outcome Measures

Primary Outcomes (3)

  • Change in depression

    Beck Depression Inventory

    baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up

  • Change in diagnosis

    SCID-I

    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)

    baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up

Secondary Outcomes (11)

  • Change in rumination

    baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up

  • Change in positive beliefs

    baseline to 10 weeks, 6 months, 12 months and 24 months follow up

  • Change in Negative beliefs

    baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up

  • Change in metacognitions

    baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up

  • Change in personality

    baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up

  • +6 more secondary outcomes

Study Arms (2)

Group metacognitive therapy (GMCT)

EXPERIMENTAL

10 weekly sessions of GMCT With 90 minutes duration

Behavioral: Group metacognitive therapy

Clinical Management

ACTIVE COMPARATOR

10 weekly individual sessions with up to 60 minutes duration

Behavioral: Clinical management

Interventions

Group metacognitive therapyBEHAVIORAL

10 weekly Group session of 90 minutes duration

Group metacognitive therapy (GMCT)
Clinical managementBEHAVIORAL

10 weekly individual sessions With clinical management including guided self-help

Clinical Management

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MDD is primary problem
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specialist practice Dr Toril Dammen

Drammen, Buskerud, 3014, Norway

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Toril Dammen, PhD

CONTACT

4790163433toril.dammen@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2018

First Posted

October 18, 2018

Study Start

November 1, 2018

Primary Completion

April 1, 2021

Study Completion

June 1, 2025

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

NO(1)