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

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ClinicalTrials.gov Identifier: NCT02648165
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
University of Oslo
University of Oxford
Karolinska Institutet
Wichita State University
The Hospital of Vestfold
Information provided by (Responsible Party):
Vegard Haaland, 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.

Condition or disease Intervention/treatment Phase
Major Depression Behavioral: Attention Bias Modification Behavioral: Sham Attention Bias Modification Behavioral: Acceptance and Commitment Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure
Study Start Date : April 2015
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABM +
Attention Bias Modification
Behavioral: Attention Bias Modification
Computer based Attention Bias Modification
Other Name: ABM+

Sham Comparator: ABM -
Sham Attention Bias Modification
Behavioral: Sham Attention Bias Modification
Computer based Sham Attention Bias Modification
Other Name: ABM-

Experimental: ABM + and ACT
Attention Bias Modification followed by Group Acceptance and Commitment Therapy
Behavioral: Attention Bias Modification
Computer based Attention Bias Modification
Other Name: ABM+

Behavioral: Acceptance and Commitment Therapy
Acceptance and Commitment Therapy delivered in a group therapy setting
Other Name: ACT

Sham Comparator: ABM - and ACT
Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy
Behavioral: Sham Attention Bias Modification
Computer based Sham Attention Bias Modification
Other Name: ABM-

Behavioral: Acceptance and Commitment Therapy
Acceptance and Commitment Therapy delivered in a group therapy setting
Other Name: ACT




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648165


Locations
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Norway
Sørlandet Hospital, Department of Psychiatry
Arendal, Aust-Agder, Norway, 4801
University of Oslo, Department of Psychology
Oslo, Norway, 0317
Sponsors and Collaborators
Sorlandet Hospital HF
University of Oslo
University of Oxford
Karolinska Institutet
Wichita State University
The Hospital of Vestfold
Investigators
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Principal Investigator: Vegard Ø Haaland, PhD Sørlandet Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vegard Haaland, Head of Department, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT02648165     History of Changes
Other Study ID Numbers: HSØ-2015056
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders