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

NCT02648165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2023-02-08

No results posted yet for this study

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

BEHAVIORAL

Attention Bias Modification

Computer based Attention Bias Modification

BEHAVIORAL

Sham Attention Bias Modification

Computer based Sham Attention Bias Modification

BEHAVIORAL

Acceptance and Commitment Therapy

Acceptance and Commitment Therapy delivered in a group therapy setting

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER
  • University of Oxford

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • Wichita State University

    collaborator OTHER
  • The Hospital of Vestfold

    collaborator OTHER
  • Sorlandet Hospital HF

    lead OTHER_GOV

Principal Investigators

  • Vegard Ø Haaland, PhD · Sørlandet Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Norway

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648165 on ClinicalTrials.gov