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

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648165
• Other study ID #: HSØ-2015056
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2019
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Major Depression

Intervention

Behavioral:
• Attention Bias Modification
Computer based Attention Bias Modification
• Sham Attention Bias Modification
Computer based Sham Attention Bias Modification
• Acceptance and Commitment Therapy
Acceptance and Commitment Therapy delivered in a group therapy setting

Locations

Country	Name	City	State
Norway	Sørlandet Hospital, Department of Psychiatry	Arendal	Aust-Agder
Norway	University of Oslo, Department of Psychology	Oslo

Sponsors (6)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Karolinska Institutet, The Hospital of Vestfold, University of Oslo, University of Oxford, Wichita State University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Recurrence of major depressive episodes	Measured by MINI structured interview	Will be measured 12 months after baseline
Secondary	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
Secondary	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
Secondary	Changes in Quality of Life - self report	WHOQOL-BREF	Will be measured at Baseline, then after 2 months, 6 months, and 12 months
Secondary	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
Secondary	Changes in Values - self report	Bulls Eye	Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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)
Secondary	Changes in Cognitive fusion - self report	Cognitive fusion questionnaire	1 month, 2 months, 6 months, 12 months (only in ACT-arms)