Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure
Primary Purpose
Major Depression
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Attention Bias Modification
Sham Attention Bias Modification
Acceptance and Commitment Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Major Depression
Eligibility 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.
Sites / Locations
- Sørlandet Hospital, Department of Psychiatry
- University of Oslo, Department of Psychology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Experimental
Sham Comparator
Arm Label
ABM +
ABM -
ABM + and ACT
ABM - and ACT
Arm Description
Attention Bias Modification
Sham Attention Bias Modification
Attention Bias Modification followed by Group Acceptance and Commitment Therapy
Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy
Outcomes
Primary Outcome Measures
Change in residual symptoms of depression - self report
Change in residual symptoms of depression as measured by Beck Depression Inventory
Change in residual symptoms of depression - clinician rating
Change in residual symptoms of depression as rated by Hamilton Rating Scale for Depression
Secondary Outcome Measures
Recurrence of major depressive episodes
Measured by MINI structured interview
Changes in Cortisol response
Cortisol measured in salvia. Samples taken in the morning on three days in succession.
Changes in symptoms of anxiety - self report
Change in symptoms of anxiety as measured by Beck Anxiety Inventory
Changes in Quality of Life - self report
WHOQOL-BREF
Changes in Acceptance - self report
The 7-item Acceptance and Action Questionnaire - II (AAQ-II)
Changes in Values - self report
Bulls Eye
Changes in Values and committed action - self report
Engaged living scale
Changes in Emotional, Psychological and Social Well-Being - self report
Mental Health continuum - short form
Changes in Present-moment awareness and acceptance - self report
Philadelphia mindfulness scale
Changes in Cognitive fusion - self report
Cognitive fusion questionnaire
Full Information
NCT ID
NCT02648165
First Posted
January 5, 2016
Last Updated
February 3, 2023
Sponsor
Sorlandet Hospital HF
Collaborators
University of Oslo, University of Oxford, Karolinska Institutet, Wichita State University, The Hospital of Vestfold
1. Study Identification
Unique Protocol Identification Number
NCT02648165
Brief Title
Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure
Official Title
Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
Collaborators
University of Oslo, University of Oxford, Karolinska Institutet, Wichita State University, The Hospital of Vestfold
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABM +
Arm Type
Experimental
Arm Description
Attention Bias Modification
Arm Title
ABM -
Arm Type
Sham Comparator
Arm Description
Sham Attention Bias Modification
Arm Title
ABM + and ACT
Arm Type
Experimental
Arm Description
Attention Bias Modification followed by Group Acceptance and Commitment Therapy
Arm Title
ABM - and ACT
Arm Type
Sham Comparator
Arm Description
Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification
Other Intervention Name(s)
ABM+
Intervention Description
Computer based Attention Bias Modification
Intervention Type
Behavioral
Intervention Name(s)
Sham Attention Bias Modification
Other Intervention Name(s)
ABM-
Intervention Description
Computer based Sham Attention Bias Modification
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Other Intervention Name(s)
ACT
Intervention Description
Acceptance and Commitment Therapy delivered in a group therapy setting
Primary Outcome Measure Information:
Title
Change in residual symptoms of depression - self report
Description
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
Title
Change in residual symptoms of depression - clinician rating
Description
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
Secondary Outcome Measure Information:
Title
Recurrence of major depressive episodes
Description
Measured by MINI structured interview
Time Frame
Will be measured 12 months after baseline
Title
Changes in Cortisol response
Description
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
Title
Changes in symptoms of anxiety - self report
Description
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
Title
Changes in Quality of Life - self report
Description
WHOQOL-BREF
Time Frame
Will be measured at Baseline, then after 2 months, 6 months, and 12 months
Title
Changes in Acceptance - self report
Description
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
Title
Changes in Values - self report
Description
Bulls Eye
Time Frame
Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Title
Changes in Values and committed action - self report
Description
Engaged living scale
Time Frame
Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Title
Changes in Emotional, Psychological and Social Well-Being - self report
Description
Mental Health continuum - short form
Time Frame
Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Title
Changes in Present-moment awareness and acceptance - self report
Description
Philadelphia mindfulness scale
Time Frame
Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Title
Changes in Cognitive fusion - self report
Description
Cognitive fusion questionnaire
Time Frame
1 month, 2 months, 6 months, 12 months (only in ACT-arms)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Ø Haaland, PhD
Organizational Affiliation
Sørlandet Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sørlandet Hospital, Department of Psychiatry
City
Arendal
State/Province
Aust-Agder
ZIP/Postal Code
4801
Country
Norway
Facility Name
University of Oslo, Department of Psychology
City
Oslo
ZIP/Postal Code
0317
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29587807
Citation
Ostergaard T, Lundgren T, Zettle R, Jonassen R, Harmer CJ, Stiles TC, Landro NI, Haaland VO. Acceptance and Commitment Therapy preceded by an experimental Attention Bias Modification procedure in recurrent depression: study protocol for a randomized controlled trial. Trials. 2018 Mar 27;19(1):203. doi: 10.1186/s13063-018-2515-9.
Results Reference
derived
Learn more about this trial
Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure
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