Attention Bias Modification
BehavioralComputer based Attention Bias Modification
Other names: ABM+
NCT Number: NCT02648165
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Sørlandet Hospital, Department of Psychiatry, Arendal, Aust-Agder, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Computer based Attention Bias Modification
Other names: ABM+
Computer based Sham Attention Bias Modification
Other names: ABM-
Acceptance and Commitment Therapy delivered in a group therapy setting
Other names: ACT
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 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 as rated by Hamilton Rating Scale for Depression
Time frame: Will be measured 12 months after baseline
Measured by MINI structured interview
Time frame: 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.
Time frame: 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
Time frame: Will be measured at Baseline, then after 2 months, 6 months, and 12 months
WHOQOL-BREF
Time frame: 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)
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Bulls Eye
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Engaged living scale
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Mental Health continuum - short form
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Philadelphia mindfulness scale
Time frame: 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Cognitive fusion questionnaire
Sorlandet Hospital HF
Other Gov
Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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