Effects of Behavioural Activation on Emotional Cognition and Mood

Depression Clinical Trial

Official title:

Effects of Behavioural Activation on Emotional Cognition and Mood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995186
• Other study ID #: Beh_Act_ETB
• Status: Completed
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognition
• Depression
• Depressive Disorder
• Disease
• Mood Disorders

Intervention

Behavioral:
• 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.
• Activity monitoring
4-week programme where participants simply monitor their general daily activities in a diary.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Median scores on the daily Mood Zoom questionnaire	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.	5 weeks
Secondary	Motor activity	Motor activity (in Hz) as measured by the GeneActive actigraphy watch	5 weeks
Secondary	Change in speed during recognition of positive and negative facial expressions	Reaction times for correctly recognised positive versus negative faces in facial expression recognition task (FERT)	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	Change in emotional categorisation (ECAT)	Reaction times for correctly classifying positive versus negative personality characteristic words	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	Change in recall in the Emotional memory task (EREC)	Number of positive and negative words correctly (and incorrectly) recalled in the EREC task	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	Change in reward sensitivity	Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	Change in performance on Auditory Verbal Learning Task (AVLT)	Accuracy on AVLT (number of items recalled across blocks)	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	Change in levels of behavioural activation	Score on the Behavioural Activation for Depression Scale (total score range 0-150). Higher scores indicate higher levels of activation.	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	Change in mood	Score on the Beck Depression Inventory (total score range 0-63). Higher scores indicate higher levels of depression.	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	FERT as a possible predictor of mood change	Correlation between Hit rate on the FERT at week 3 and the change in BDI at week 5	Will be assessed at week 3 and week 5 of the intervention
Secondary	Change in environmental reward	Score on the Environmental reward observation scale (total score range 10-40). Higher scores indicate higher levels of environmental reward.	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	Change in subjective experience of social support	Score on the Multidimensional Scale of Perceived Social Support (total score range 12-84). Higher scores indicate higher levels of support.	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	Change in anxiety	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.	Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary	EREC as a possible predictor of mood change	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	Will be assessed at week 3 and week 5 of the intervention
Secondary	ECAT as a possible predictor of mood change	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	Will be assessed at week 3 and week 5 of the intervention
Secondary	FERT as a possible predictor of mood change	Correlation between Reaction times on the FERT at week 3 and the change in BDI at week 5	Will be assessed at week 3 and week 5 of the intervention