Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure
- Conditions
- Major Depression
- Interventions
- Behavioral: Attention Bias ModificationBehavioral: Sham Attention Bias ModificationBehavioral: Acceptance and Commitment Therapy
- Registration Number
- NCT02648165
- Lead Sponsor
- Sorlandet Hospital HF
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
- Subjects with a history of major depression, currently in remission
- Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABM + Attention Bias Modification Attention Bias Modification ABM - and ACT Acceptance and Commitment Therapy Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy ABM + and ACT Attention Bias Modification Attention Bias Modification followed by Group Acceptance and Commitment Therapy ABM - and ACT Sham Attention Bias Modification Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy ABM - Sham Attention Bias Modification Sham Attention Bias Modification ABM + and ACT Acceptance and Commitment Therapy Attention Bias Modification followed by Group Acceptance and Commitment Therapy
- Primary Outcome Measures
Name Time Method Change in residual symptoms of depression - self report 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 as measured by Beck Depression Inventory
Change in residual symptoms of depression - clinician rating 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 as rated by Hamilton Rating Scale for Depression
- Secondary Outcome Measures
Name Time Method Changes in Values - self report Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months Bulls Eye
Changes in Acceptance - self report Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months The 7-item Acceptance and Action Questionnaire - II (AAQ-II)
Changes in Emotional, Psychological and Social Well-Being - self report Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months Mental Health continuum - short form
Changes in Cortisol response Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months Cortisol measured in salvia. Samples taken in the morning on three days in succession.
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 Change in symptoms of anxiety as measured by Beck Anxiety Inventory
Changes in Quality of Life - self report Will be measured at Baseline, then after 2 months, 6 months, and 12 months WHOQOL-BREF
Changes in Values and committed action - self report Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months Engaged living scale
Recurrence of major depressive episodes Will be measured 12 months after baseline Measured by MINI structured interview
Changes in Present-moment awareness and acceptance - self report Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms) Philadelphia mindfulness scale
Changes in Cognitive fusion - self report 1 month, 2 months, 6 months, 12 months (only in ACT-arms) Cognitive fusion questionnaire
Trial Locations
- Locations (2)
Sørlandet Hospital, Department of Psychiatry
🇳🇴Arendal, Aust-Agder, Norway
University of Oslo, Department of Psychology
🇳🇴Oslo, Norway
Sørlandet Hospital, Department of Psychiatry🇳🇴Arendal, Aust-Agder, Norway