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

NCT ID: NCT02648165

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-11-30

Brief 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

Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

ABM +

Attention Bias Modification

Group Type: EXPERIMENTAL

Attention Bias Modification

Intervention Type: BEHAVIORAL

Computer based Attention Bias Modification

ABM -

Sham Attention Bias Modification

Group Type: SHAM_COMPARATOR

Sham Attention Bias Modification

Intervention Type: BEHAVIORAL

Computer based Sham Attention Bias Modification

ABM + and ACT

Attention Bias Modification followed by Group Acceptance and Commitment Therapy

Group Type: EXPERIMENTAL

Attention Bias Modification

Intervention Type: BEHAVIORAL

Computer based Attention Bias Modification

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

Acceptance and Commitment Therapy delivered in a group therapy setting

ABM - and ACT

Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy

Group Type: SHAM_COMPARATOR

Sham Attention Bias Modification

Intervention Type: BEHAVIORAL

Computer based Sham Attention Bias Modification

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

Acceptance and Commitment Therapy delivered in a group therapy setting

Interventions

Attention Bias Modification

Computer based Attention Bias Modification

Intervention Type: BEHAVIORAL

Sham Attention Bias Modification

Computer based Sham Attention Bias Modification

Intervention Type: BEHAVIORAL

Acceptance and Commitment Therapy

Acceptance and Commitment Therapy delivered in a group therapy setting

Intervention Type: BEHAVIORAL

Other Intervention Names

ABM+; ABM-; ACT

Eligibility Criteria

Inclusion Criteria

• Subjects with a history of major depression, currently in remission

Exclusion Criteria

• Current or past neurological illness, bipolar disorder, psychosis or drug addiction.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Wichita State University

OTHER

Sponsor Role: collaborator

The Hospital of Vestfold

OTHER

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vegard Ø Haaland, PhD

Role: PRINCIPAL_INVESTIGATOR

Sørlandet Hospital

Locations

Sørlandet Hospital, Department of Psychiatry

Arendal, Aust-Agder, Norway

University of Oslo, Department of Psychology

Oslo, , Norway

Countries

Norway

References

Ostergaard T, Lundgren T, Zettle R, Jonassen R, Harmer CJ, Stiles TC, Landro NI, Haaland VO. Acceptance and Commitment Therapy preceded by an experimental Attention Bias Modification procedure in recurrent depression: study protocol for a randomized controlled trial. Trials. 2018 Mar 27;19(1):203. doi: 10.1186/s13063-018-2515-9.

Reference Type: DERIVED

PMID: 29587807 (View on PubMed)

Other Identifiers

HSØ-2015056

Identifier Type: -

Identifier Source: org_study_id