Clinical trial NCT03995186: Effects of Behavioural Activation on Emotional Cognition and Mood
Official title: Effects of Behavioural Activation on Emotional Cognition and Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder
Mood Disorders
Cognition
Keywords: behavioural activation
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Change in recognition of positive and negative facial expressions from baseline at week 2 and 4
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary outcomes:
measure: Median scores on the daily Mood Zoom questionnaire
timeFrame: 5 weeks
measure: Motor activity
timeFrame: 5 weeks
measure: Change in speed during recognition of positive and negative facial expressions
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: Change in emotional categorisation (ECAT)
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: Change in recall in the Emotional memory task (EREC)
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: Change in reward sensitivity
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: Change in performance on Auditory Verbal Learning Task (AVLT)
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: Change in levels of behavioural activation
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: Change in mood
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: FERT as a possible predictor of mood change
timeFrame: Will be assessed at week 3 and week 5 of the intervention
measure: Change in environmental reward
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: Change in subjective experience of social support
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: Change in anxiety
timeFrame: Will be assessed at week 0, week 3 and week 5 of the intervention
measure: EREC as a possible predictor of mood change
timeFrame: Will be assessed at week 3 and week 5 of the intervention
measure: ECAT as a possible predictor of mood change
timeFrame: Will be assessed at week 3 and week 5 of the intervention
measure: FERT as a possible predictor of mood change
timeFrame: Will be assessed at week 3 and week 5 of the intervention
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
References: