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

• ClinicalTrials.gov Identifier: NCT02648165
• Recruitment Status: Completed
• First Posted: January 6, 2016
• Last Update Posted: February 8, 2023
• Sponsor: Sorlandet Hospital HF
• Collaborators: University of Oslo; University of Oxford; Karolinska Institutet; Wichita State University; The Hospital of Vestfold
• Information provided by (Responsible Party): Sorlandet Hospital HF

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Vegard Ø Haaland, PhD; Sørlandet Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sorlandet Hospital HF
• ClinicalTrials.gov Identifier: NCT02648165
• Other Study ID Numbers: HSØ-2015056
• First Posted: January 6, 2016
• Last Update Posted: February 8, 2023
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders