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

Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02648165
Enrollment
224
Registered
2016-01-06
Start date
2015-04-30
Completion date
2018-11-30
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

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.

Interventions

BEHAVIORALAttention Bias Modification

Computer based Attention Bias Modification

Computer based Sham Attention Bias Modification

BEHAVIORALAcceptance and Commitment Therapy

Acceptance and Commitment Therapy delivered in a group therapy setting

Sponsors

University of Oslo
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
Wichita State University
CollaboratorOTHER
The Hospital of Vestfold
CollaboratorOTHER
Sorlandet Hospital HF
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in residual symptoms of depression - self reportWill be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 monthsChange in residual symptoms of depression as measured by Beck Depression Inventory
Change in residual symptoms of depression - clinician ratingWill be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 monthsChange in residual symptoms of depression as rated by Hamilton Rating Scale for Depression

Secondary

MeasureTime frameDescription
Changes in symptoms of anxiety - self reportWill be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 monthsChange in symptoms of anxiety as measured by Beck Anxiety Inventory
Changes in Quality of Life - self reportWill be measured at Baseline, then after 2 months, 6 months, and 12 monthsWHOQOL-BREF
Changes in Acceptance - self reportWill be measured at Baseline, then after 1 month, 2 months, 6 months, 12 monthsThe 7-item Acceptance and Action Questionnaire - II (AAQ-II)
Changes in Values - self reportWill be measured at Baseline, then after 1 month, 2 months, 6 months, 12 monthsBulls Eye
Recurrence of major depressive episodesWill be measured 12 months after baselineMeasured by MINI structured interview
Changes in Emotional, Psychological and Social Well-Being - self reportWill be measured at Baseline, then after 1 month, 2 months, 6 months, 12 monthsMental Health continuum - short form
Changes in Present-moment awareness and acceptance - self reportWill 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 report1 month, 2 months, 6 months, 12 months (only in ACT-arms)Cognitive fusion questionnaire
Changes in Values and committed action - self reportWill be measured at Baseline, then after 1 month, 2 months, 6 months, 12 monthsEngaged living scale
Changes in Cortisol responseWill be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 monthsCortisol measured in salvia. Samples taken in the morning on three days in succession.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026