Effects of Behavioural Activation on Emotional Cognition and Mood

Not Applicable

Completed

• Conditions: Depression; Cognition; Mood Disorders; Depressive Disorder
• Interventions: Behavioral: Activity monitoring; Behavioral: Behavioural activation

• Registration Number: NCT03995186
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity monitoring group	Activity monitoring	-
Behavioural activation group	Behavioural activation	-

Primary Outcome Measures

Name	Time	Method
Change in recognition of positive and negative facial expressions from baseline at week 2 and 4	Will be assessed at week 0, week 3 and week 5 of the intervention	Hit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)

Secondary Outcome Measures

Name	Time	Method
Change in mood	Will be assessed at week 0, week 3 and week 5 of the intervention	Score on the Beck Depression Inventory (total score range 0-63). Higher scores indicate higher levels of depression.
Change in environmental reward	Will be assessed at week 0, week 3 and week 5 of the intervention	Score on the Environmental reward observation scale (total score range 10-40). Higher scores indicate higher levels of environmental reward.
Motor activity	5 weeks	Motor activity (in Hz) as measured by the GeneActive actigraphy watch
Change in reward sensitivity	Will be assessed at week 0, week 3 and week 5 of the intervention	Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task
Change in levels of behavioural activation	Will be assessed at week 0, week 3 and week 5 of the intervention	Score on the Behavioural Activation for Depression Scale (total score range 0-150). Higher scores indicate higher levels of activation.
Change in subjective experience of social support	Will be assessed at week 0, week 3 and week 5 of the intervention	Score on the Multidimensional Scale of Perceived Social Support (total score range 12-84). Higher scores indicate higher levels of support.
Change in anxiety	Will be assessed at week 0, week 3 and week 5 of the intervention	Score on the State-trait anxiety inventory (both State anxiety and Trait anxiety subscales scores range from 20-80). Higher scores indicate higher levels of anxiety.
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	Reaction times for correctly recognised positive versus negative faces in facial expression recognition task (FERT)
Change in emotional categorisation (ECAT)	Will be assessed at week 0, week 3 and week 5 of the intervention	Reaction times for correctly classifying positive versus negative personality characteristic words
Change in recall in the Emotional memory task (EREC)	Will be assessed at week 0, week 3 and week 5 of the intervention	Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
EREC as a possible predictor of mood change	Will be assessed at week 3 and week 5 of the intervention	Correlation between number of correctly recalled positive versus negative personality characteristic words at week 3 and and the change in BDI score at week 5
Median scores on the daily Mood Zoom questionnaire	5 weeks	Scoring six emotions (Anxious, Elated, Sad, Angry, Irritable and Energetic) on a Likert scale (scale range 1-7). Higher values represent higher levels of the emotion. The six subscales will be combined into 'Positive affect' (Elated, Energetic), 'Negative affect' (Sad, Anxious) and 'Irritability' (Angry, Irritable) scores by averaging.
Change in performance on Auditory Verbal Learning Task (AVLT)	Will be assessed at week 0, week 3 and week 5 of the intervention	Accuracy on AVLT (number of items recalled across blocks)
FERT as a possible predictor of mood change	Will be assessed at week 3 and week 5 of the intervention	Correlation between Reaction times on the FERT at week 3 and the change in BDI at week 5
ECAT as a possible predictor of mood change	Will be assessed at week 3 and week 5 of the intervention	Correlation between reaction times for correctly classifying positive versus negative personality characteristic words at week 3 and the change in BDI score at week 5

Trial Locations

Locations (1)

University of Oxford; 🇬🇧 Oxford, United Kingdom