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

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Behavioral: Attention Bias Modification; Behavioral: Sham Attention Bias Modification; Behavioral: Acceptance and Commitment Therapy

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0317
    • University of Oslo, Department of Psychology
  • Aust-Agder
    • Arendal, Aust-Agder, Norway, 4801
      • Sørlandet Hospital, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ABM +; Attention Bias Modification	Behavioral: Attention Bias Modification; Computer based Attention Bias Modification; Other Names: ABM+
SHAM_COMPARATOR: ABM -; Sham Attention Bias Modification	Behavioral: Sham Attention Bias Modification; Computer based Sham Attention Bias Modification; Other Names: 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 Names: ABM+; Behavioral: Acceptance and Commitment Therapy; Acceptance and Commitment Therapy delivered in a group therapy setting; Other Names: 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 Names: ABM-; Behavioral: Acceptance and Commitment Therapy; Acceptance and Commitment Therapy delivered in a group therapy setting; Other Names: ACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in residual symptoms of depression - self report	Change in residual symptoms of depression as measured by Beck Depression Inventory	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 - clinician rating	Change in residual symptoms of depression as rated by Hamilton Rating Scale for Depression	Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of major depressive episodes	Measured by MINI structured interview	Will be measured 12 months after baseline
Changes in Cortisol response	Cortisol measured in salvia. Samples taken in the morning on three days in succession.	Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Changes in symptoms of anxiety - self report	Change in symptoms of anxiety as measured by Beck Anxiety Inventory	Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Changes in Quality of Life - self report	WHOQOL-BREF	Will be measured at Baseline, then after 2 months, 6 months, and 12 months
Changes in Acceptance - self report	The 7-item Acceptance and Action Questionnaire - II (AAQ-II)	Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Values - self report	Bulls Eye	Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Values and committed action - self report	Engaged living scale	Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Emotional, Psychological and Social Well-Being - self report	Mental Health continuum - short form	Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Present-moment awareness and acceptance - self report	Philadelphia mindfulness scale	Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Changes in Cognitive fusion - self report	Cognitive fusion questionnaire	1 month, 2 months, 6 months, 12 months (only in ACT-arms)

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Collaborators: University of Oslo; Karolinska Institutet; University of Oxford; The Hospital of Vestfold; Wichita State University
• Investigators: Principal Investigator: Vegard Ø Haaland, PhD, Sørlandet Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (ESTIMATE): January 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: HSØ-2015056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO