Effects of Behavioural Activation on Emotional Cognition and Mood

NCT03995186 | Completed

• 1 other identifier: Beh_Act_ETB
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Depression; Depressive Disorder; Mood Disorders; Cognition

Keywords

behavioural activation

Outcome Measures

Primary Outcomes (1)

• Change in recognition of positive and negative facial expressions from baseline at week 2 and 4

  Hit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)

  Will be assessed at week 0, week 3 and week 5 of the intervention

Secondary Outcomes (16)

• Median scores on the daily Mood Zoom questionnaire

  5 weeks

• Motor activity

  5 weeks

• Change in speed during recognition of positive and negative facial expressions

  Will be assessed at week 0, week 3 and week 5 of the intervention

• Change in emotional categorisation (ECAT)

  Will be assessed at week 0, week 3 and week 5 of the intervention

• Change in recall in the Emotional memory task (EREC)

  Will be assessed at week 0, week 3 and week 5 of the intervention

Study Arms (3)

Behavioural activation group

EXPERIMENTAL

Behavioral: Behavioural activation

Activity monitoring group

ACTIVE COMPARATOR

Behavioral: Activity monitoring

Waiting list control group

NO INTERVENTION

Interventions

Behavioural activation 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.

Behavioural activation group

Activity monitoring BEHAVIORAL

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

Activity monitoring group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Depression; Depressive Disorder; Mood Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to either the behavioural activation intervention (40 participants), activity monitoring (40 participants) or passive waiting-list control group (40 participants). This study is not intended to be administering treatment, it is investigating the possible mechanisms of this intervention.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: June 21, 2019
• Study Start: February 20, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

GB (1)