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

NCT02648165 | Completed

• 1 other identifier: HSØ-2015056
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Change in residual symptoms of depression - self report

  Change in residual symptoms of depression as measured by Beck Depression Inventory

  Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months

• Change in residual symptoms of depression - clinician rating

  Change in residual symptoms of depression as rated by Hamilton Rating Scale for Depression

  Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months

Secondary Outcomes (10)

• Recurrence of major depressive episodes

  Will be measured 12 months after baseline

• Changes in Cortisol response

  Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months

• Changes in symptoms of anxiety - self report

  Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months

• Changes in Quality of Life - self report

  Will be measured at Baseline, then after 2 months, 6 months, and 12 months

• Changes in Acceptance - self report

  Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months

Study Arms (4)

ABM +

EXPERIMENTAL

Attention Bias Modification

Behavioral: Attention Bias Modification

ABM -

SHAM COMPARATOR

Sham Attention Bias Modification

Behavioral: Sham Attention Bias Modification

ABM + and ACT

EXPERIMENTAL

Attention Bias Modification followed by Group Acceptance and Commitment Therapy

Behavioral: Attention Bias Modification; Behavioral: Acceptance and Commitment Therapy

ABM - and ACT

SHAM COMPARATOR

Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy

Behavioral: Sham Attention Bias Modification; Behavioral: Acceptance and Commitment Therapy

Interventions

Attention Bias Modification BEHAVIORAL

Computer based Attention Bias Modification

Also known as: ABM+

ABM +; ABM + and ACT

Sham Attention Bias Modification BEHAVIORAL

Computer based Sham Attention Bias Modification

Also known as: ABM-

ABM -; ABM - and ACT

Acceptance and Commitment Therapy BEHAVIORAL

Acceptance and Commitment Therapy delivered in a group therapy setting

Also known as: ACT

ABM + and ACT; ABM - and ACT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• University of Oslo: collaborator
• University of Oxford: collaborator
• Karolinska Institutet: collaborator
• Wichita State University: collaborator
• The Hospital of Vestfold: collaborator

Study Sites (2)

Sørlandet Hospital, Department of Psychiatry

Arendal, Aust-Agder, 4801, Norway

Location

University of Oslo, Department of Psychology

Oslo, 0317, Norway

Location

Related Publications (1)

• 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.

  PMID: 29587807 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Vegard Ø Haaland, PhD

  Sørlandet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 6, 2016
• Study Start: April 1, 2015
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: February 8, 2023

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)