Clinical Trials Directory

Trials / Completed

CompletedNCT02648165

Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure

Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
224 (actual)
Sponsor
Sorlandet Hospital HF · Other Government
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Depression (major depressive disorder; MDD) is a very common mental disorder. Research suggests that individuals with prior depressive episodes have a risk of the relapse or recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term management of the disease. The current project aims to investigate whether group based Acceptance and Commitment Therapy (ACT) can reduce surrogate and clinical markers of relapse in a group highly vulnerable to depressive episodes. The group intervention will consist of eight sessions, and each group will consist of maximum 12 persons. The project also studies whether Attention Bias Modification (ABM) preceding the ACT intervention will enhance the effect. ABM will be administered over a fourteen days period prior to the ACT-intervention. Effect will be measured over a period of 12 months. The primary outcome is changes in depressive symptoms. ACT-specific secondary outcome measures are also included. Subjects with a history of major depression (n=200), currently in remission, will be recruited from Sørlandet Hospital (100 participants). Matched participants (100 participants) will be recruited at the University of Oslo. In the first phase, participants from Sørlandet hospital will be randomized to ABM treatment or control condition. In the second phase all participants from Sørlandet hospital will receive group based ACT treatment. Group based ACT and ABM represent interventions that are time and cost effective, and that could be made available to large number of individuals struggling with MDD.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAttention Bias ModificationComputer based Attention Bias Modification
BEHAVIORALSham Attention Bias ModificationComputer based Sham Attention Bias Modification
BEHAVIORALAcceptance and Commitment TherapyAcceptance and Commitment Therapy delivered in a group therapy setting

Timeline

Start date
2015-04-01
Primary completion
2018-11-30
Completion
2018-11-30
First posted
2016-01-06
Last updated
2023-02-08

Locations

2 sites across 1 country: Norway

Source: ClinicalTrials.gov record NCT02648165. Inclusion in this directory is not an endorsement.