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

Sorlandet Hospital HF

Status: Completed

Conditions: Major Depression

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02648165

HSØ-2015056

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

224 participants in 4 patient groups

ABM +

Experimental group

Description:

Attention Bias Modification

Treatment:

Behavioral: Attention Bias Modification

ABM -

Sham Comparator group

Description:

Sham Attention Bias Modification

Treatment:

Behavioral: Sham Attention Bias Modification

ABM + and ACT

Experimental group

Description:

Attention Bias Modification followed by Group Acceptance and Commitment Therapy

Treatment:

Behavioral: Acceptance and Commitment Therapy

Behavioral: Attention Bias Modification

ABM - and ACT

Sham Comparator group

Description:

Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy

Treatment:

Behavioral: Acceptance and Commitment Therapy

Behavioral: Sham Attention Bias Modification