Clinical trial NCT02648165: Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure
Official title: Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Oslo
name: University of Oxford
name: Karolinska Institutet
name: Wichita State University
name: The Hospital of Vestfold
First posted: 2016-01-06
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change in residual symptoms of depression - self report
timeFrame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
measure: Change in residual symptoms of depression - clinician rating
timeFrame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Secondary outcomes:
measure: Recurrence of major depressive episodes
timeFrame: Will be measured 12 months after baseline
measure: Changes in Cortisol response
timeFrame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
measure: Changes in symptoms of anxiety - self report
timeFrame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
measure: Changes in Quality of Life - self report
timeFrame: Will be measured at Baseline, then after 2 months, 6 months, and 12 months
measure: Changes in Acceptance - self report
timeFrame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
measure: Changes in Values - self report
timeFrame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
measure: Changes in Values and committed action - self report
timeFrame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
measure: Changes in Emotional, Psychological and Social Well-Being - self report
timeFrame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
measure: Changes in Present-moment awareness and acceptance - self report
timeFrame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
measure: Changes in Cognitive fusion - self report
timeFrame: 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sørlandet Hospital, Department of Psychiatry
state: Aust-Agder
city: Oslo
country: Norway
facility: University of Oslo, Department of Psychology
Study officials:
affiliation: Sørlandet Hospital
name: Vegard Ø Haaland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.