Effects of Behavioural Activation on Emotional Cognition and Mood

NCT ID: NCT03995186

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2021-09-30

Brief Summary

Behavioural activation (BA) is widely accepted as an efficacious treatment for depression. It has been suggested that several depression treatments work via early changes in emotional processing (e.g. affective bias in the processing of facial expressions) and that these could help predict treatment success, but it has not yet been examined whether the same applies in behavioural interventions. The investigators will examine how BA affects early emotional information processing in participants who are currently experiencing low mood, to see whether this can predict eventual changes in mood and to gain a better understanding of the treatment mechanisms of BA. Participants will be in three groups undergoing either behavioural activation, or activity monitoring alone (active control) for 4 weeks, or they will be on a waiting list (passive control). The investigators will also examine whether other factors, such as anxiety, social support and environmental reward, can predict the success of BA. This could help us understand how BA works and who may be most suitable for this intervention.

Conditions

Cognition; Depression; Depressive Disorder; Mood Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Behavioural activation group

Group Type: EXPERIMENTAL

Behavioural activation

Intervention Type: BEHAVIORAL

4-week programme based on the behavioural activation treatment provided in the NHS IAPT services. The programme includes psychoeducation on the relationship between activity and depression, examining the depressed person's level of activity, helping them identify activities they would like to increase and supporting them in the planning and conduct of those activities.

Activity monitoring group

Group Type: ACTIVE_COMPARATOR

Activity monitoring

Intervention Type: BEHAVIORAL

4-week programme where participants simply monitor their general daily activities in a diary.

Waiting list control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioural activation

4-week programme based on the behavioural activation treatment provided in the NHS IAPT services. The programme includes psychoeducation on the relationship between activity and depression, examining the depressed person's level of activity, helping them identify activities they would like to increase and supporting them in the planning and conduct of those activities.

Intervention Type: BEHAVIORAL

Activity monitoring

4-week programme where participants simply monitor their general daily activities in a diary.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female or male
• Age: 18 to 65 years
• Competency to give informed consent
• Scores above 14 on BDI-2 (bottom criterion for mild depression)

Exclusion Criteria

• Previous participation in a study that used the emotional test battery (ETB)
• Currently undergoing any form of psychotherapy or counselling
• Taking antidepressant medication for less than 3 months, or changing existing psychiatric medication within the past month
• Current or past a diagnosis of psychosis or a bipolar disorder
• Current diagnosis of an eating disorder, a borderline personality disorder, or a substance abuse disorder
• Any other factor that would indicate the participant isn't able to comply with the requirements of the study according to the opinion of the chief investigator (severe insomnia, chronic fatigue syndrome, neurological conditions impairing cognitive function etc.)
• Symptoms of depression are too severe (score 20 and above on the PHQ-9 questionnaire or according to the evaluation of study psychiatrist)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Catherine Harmer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Oxford

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

Beh_Act_ETB

Identifier Type: -

Identifier Source: org_study_id