Effects of Behavioural Activation on Emotional Cognition and Mood

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Behavioural Activation on Emotional Cognition and Mood

Conditions
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Depression, Depressive Disorder, Mood Disorders, Cognition

Intervention / Treatment
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* Behavioral: Behavioural activation
* Behavioral: Activity monitoring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioural activation group<br> | Behavioral: Behavioural activation<br>* 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.<br>|
| Active Comparator: Activity monitoring group<br> | Behavioral: Activity monitoring<br>* 4-week programme where participants simply monitor their general daily activities in a diary.<br>|
| No Intervention: Waiting list control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Motor activity | Motor activity (in Hz) as measured by the GeneActive actigraphy watch | 5 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioural activation