NCT01608399

Brief Summary

The main aim of this study is to (1) evaluate the effectiveness of metacognitive therapy for major depressive disorder. Additional aims are to (2) investigate patterns of change and the mechanisms of action involved during treatment, and to (3) examine the impact of meta-cognitions in the treatment and relapse prevention of depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

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

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

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

February 9, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

February 9, 2012

Last Update Submit

August 24, 2019

Conditions

Major Depressive Disorder

Keywords

major depressive disorderpsychotherapymetacognitive therapy

Outcome Measures

Primary Outcomes (2)

  • Change in depression

    Hamilton Depression Rating Scale (HDRS-17; Hamilton, 1967)

    baseline (before treatment), week 1-11, 12 months follow-up

  • Change in diagnosis

    SCID I and II (First et al., 1995, 1997)

    baseline (before treatment), week 11, 12 months follow-up

Secondary Outcomes (11)

  • Change in depression

    baseline (before treatment), week 1-11, 6 and 12 months follow-up

  • Change in anxiety

    baseline (before treatment), week 1-11, 6 and 12 months follow-up

  • Change in automatic thought

    baseline (before treatment), week 11, 6 and 12 months follow-up

  • Change in rumination

    baseline (before treatment), week 11, 6 and 12 months follow-up

  • Change in positive beliefs

    baseline (before treatment), week 11, 6 and 12 months follow-up

  • +6 more secondary outcomes

Study Arms (2)

Metacognitive therapy

EXPERIMENTAL
Behavioral: Metacognitive therapy

Waiting list control

NO INTERVENTION

Interventions

Metacognitive therapyBEHAVIORAL

Metacognitive therapy, 10 weekly sessions of 45-60 minutes duration each

Metacognitive therapy

Eligibility Criteria

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

You may qualify if:

  • Major depressive disorder
  • years or older
  • Signed written informed consent prior to entry in the study

You may not qualify if:

  • Known somatic disease
  • Psychosis
  • Current suicide intent
  • PTSD
  • Cluster A or cluster B personality disorder
  • Substance dependence
  • Not willing to accept random allocation
  • Not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of psychology, Norwegian University of Science and Technology

Trondheim, 7491, Norway

Location

Related Publications (2)

  • Hjemdal O, Solem S, Hagen R, Kennair LEO, Nordahl HM, Wells A. A Randomized Controlled Trial of Metacognitive Therapy for Depression: Analysis of 1-Year Follow-Up. Front Psychol. 2019 Aug 8;10:1842. doi: 10.3389/fpsyg.2019.01842. eCollection 2019.

    PMID: 31440193BACKGROUND

  • Hagen R, Hjemdal O, Solem S, Kennair LE, Nordahl HM, Fisher P, Wells A. Metacognitive Therapy for Depression in Adults: A Waiting List Randomized Controlled Trial with Six Months Follow-Up. Front Psychol. 2017 Jan 24;8:31. doi: 10.3389/fpsyg.2017.00031. eCollection 2017.

    PMID: 28174547RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Roger Hagen, PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2012

First Posted

May 31, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

NO(1)