- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995186
Effects of Behavioural Activation on Emotional Cognition and Mood
May 9, 2023 updated by: Catherine Harmer, University of Oxford
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Catherine Harmer, DPhil
- Phone Number: +44 (0)1865 618326
- Email: catherine.harmer@psych.ox.ac.uk
Study Contact Backup
- Name: Susannah Murphy, DPhil
- Email: susannah.murphy@psych.ox.ac.uk
Study Locations
-
-
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Oxford, United Kingdom, OX3 7JX
- University of Oxford
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioural activation group
|
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.
|
Active Comparator: Activity monitoring group
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4-week programme where participants simply monitor their general daily activities in a diary.
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No Intervention: Waiting list control group
|
What is the study measuring?
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
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)
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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
Time Frame: 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.
|
5 weeks
|
Motor activity
Time Frame: 5 weeks
|
Motor activity (in Hz) as measured by the GeneActive actigraphy watch
|
5 weeks
|
Change in speed during recognition of positive and negative facial expressions
Time Frame: 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)
|
Will be assessed at week 0, week 3 and week 5 of the intervention
|
Change in emotional categorisation (ECAT)
Time Frame: 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
|
Will be assessed at week 0, week 3 and week 5 of the intervention
|
Change in recall in the Emotional memory task (EREC)
Time Frame: 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
|
Will be assessed at week 0, week 3 and week 5 of the intervention
|
Change in reward sensitivity
Time Frame: 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
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Will be assessed at week 0, week 3 and week 5 of the intervention
|
Change in performance on Auditory Verbal Learning Task (AVLT)
Time Frame: Will be assessed at week 0, week 3 and week 5 of the intervention
|
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
Time Frame: 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.
|
Will be assessed at week 0, week 3 and week 5 of the intervention
|
Change in mood
Time Frame: 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.
|
Will be assessed at week 0, week 3 and week 5 of the intervention
|
FERT as a possible predictor of mood change
Time Frame: Will be assessed at week 3 and week 5 of the intervention
|
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
Time Frame: 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.
|
Will be assessed at week 0, week 3 and week 5 of the intervention
|
Change in subjective experience of social support
Time Frame: 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.
|
Will be assessed at week 0, week 3 and week 5 of the intervention
|
Change in anxiety
Time Frame: 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.
|
Will be assessed at week 0, week 3 and week 5 of the intervention
|
EREC as a possible predictor of mood change
Time Frame: 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
|
Will be assessed at week 3 and week 5 of the intervention
|
ECAT as a possible predictor of mood change
Time Frame: 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
|
Will be assessed at week 3 and week 5 of the intervention
|
FERT as a possible predictor of mood change
Time Frame: 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
|
Will be assessed at week 3 and week 5 of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2019
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
April 23, 2019
First Submitted That Met QC Criteria
June 20, 2019
First Posted (Actual)
June 21, 2019
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Beh_Act_ETB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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