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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
224
Computer based Attention Bias Modification
Computer based Sham Attention Bias Modification
Acceptance and Commitment Therapy delivered in a group therapy setting
Sørlandet Hospital, Department of Psychiatry
Arendal, Aust-Agder, Norway
University of Oslo, Department of Psychology
Oslo, Norway
Change in residual symptoms of depression - self report
Change in residual symptoms of depression as measured by Beck Depression Inventory
Time frame: 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
Time frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Recurrence of major depressive episodes
Measured by MINI structured interview
Time frame: Will be measured 12 months after baseline
Changes in Cortisol response
Cortisol measured in salvia. Samples taken in the morning on three days in succession.
Time frame: 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
Change in symptoms of anxiety as measured by Beck Anxiety Inventory
Time frame: 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
WHOQOL-BREF
Time frame: Will be measured at Baseline, then after 2 months, 6 months, and 12 months
Changes in Acceptance - self report
The 7-item Acceptance and Action Questionnaire - II (AAQ-II)
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Values - self report
Bulls Eye
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Values and committed action - self report
Engaged living scale
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Emotional, Psychological and Social Well-Being - self report
Mental Health continuum - short form
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Present-moment awareness and acceptance - self report
Philadelphia mindfulness scale
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Changes in Cognitive fusion - self report
Cognitive fusion questionnaire
Time frame: 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
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