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Clinical Trials/NCT03995186
NCT03995186
Completed
Not Applicable

Effects of Behavioural Activation on Emotional Cognition and Mood

University of Oxford1 site in 1 country97 target enrollmentFebruary 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Oxford
Enrollment
97
Locations
1
Primary Endpoint
Change in recognition of positive and negative facial expressions from baseline at week 2 and 4
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2019
End Date
September 30, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine Harmer

Professor

University of Oxford

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)

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Change in mood(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in environmental reward(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Motor activity(5 weeks)
  • Change in reward sensitivity(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in levels of behavioural activation(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in subjective experience of social support(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in anxiety(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • 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)
  • EREC as a possible predictor of mood change(Will be assessed at week 3 and week 5 of the intervention)
  • Median scores on the daily Mood Zoom questionnaire(5 weeks)
  • Change in performance on Auditory Verbal Learning Task (AVLT)(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • FERT as a possible predictor of mood change(Will be assessed at week 3 and week 5 of the intervention)
  • ECAT as a possible predictor of mood change(Will be assessed at week 3 and week 5 of the intervention)

Study Sites (1)

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