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Completed

NCT Number: NCT02648165

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sørlandet Hospital, Department of Psychiatry, Arendal, Aust-Agder, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Attention Bias Modification

Behavioral

Computer based Attention Bias Modification

Other names: ABM+

Sham Attention Bias Modification

Behavioral

Computer based Sham Attention Bias Modification

Other names: ABM-

Acceptance and Commitment Therapy

Behavioral

Acceptance and Commitment Therapy delivered in a group therapy setting

Other names: ACT

Primary outcomes

  1. Change in residual symptoms of depression - self report

    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

  2. Change in residual symptoms of depression - clinician rating

    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

Secondary outcomes

  1. Recurrence of major depressive episodes

    Time frame: Will be measured 12 months after baseline

    Measured by MINI structured interview

  2. Changes in Cortisol response

    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.

  3. Changes in symptoms of anxiety - self report

    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

  4. Changes in Quality of Life - self report

    Time frame: Will be measured at Baseline, then after 2 months, 6 months, and 12 months

    WHOQOL-BREF

  5. Changes in Acceptance - self report

    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)

  6. Changes in Values - self report

    Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months

    Bulls Eye

  7. Changes in Values and committed action - self report

    Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months

    Engaged living scale

  8. Changes in Emotional, Psychological and Social Well-Being - self report

    Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months

    Mental Health continuum - short form

  9. Changes in Present-moment awareness and acceptance - self report

    Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)

    Philadelphia mindfulness scale

  10. Changes in Cognitive fusion - self report

    Time frame: 1 month, 2 months, 6 months, 12 months (only in ACT-arms)

    Cognitive fusion questionnaire

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Karolinska Institutet
  • The Hospital of Vestfold
  • University of Oslo
  • University of Oxford
  • Wichita State University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2016
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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