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Effects of Behavioural Activation on Emotional Cognition and Mood

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ClinicalTrials.gov Identifier: NCT03995186
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
CatherineHarmer, University of Oxford

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.

Condition or disease Intervention/treatment Phase
Depression Depressive Disorder Mood Disorders Cognition Behavioral: Behavioural activation Behavioral: Activity monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Behavioural Activation on Emotional Cognition and Mood
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioural activation group 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.

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

No Intervention: Waiting list control group



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Motor activity [ Time Frame: 5 weeks ]
    Motor activity (in Hz) as measured by the GeneActive actigraphy watch

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995186


Contacts
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Contact: Catherine Harmer, DPhil +44 (0)1865 618326 catherine.harmer@psych.ox.ac.uk
Contact: Susannah Murphy, DPhil susannah.murphy@psych.ox.ac.uk

Locations
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United Kingdom
University of Oxford Recruiting
Oxford, United Kingdom, OX3 7JX
Contact: Catherine Harmer, Professor         
Sponsors and Collaborators
University of Oxford
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Responsible Party: CatherineHarmer, Professor, University of Oxford
ClinicalTrials.gov Identifier: NCT03995186    
Other Study ID Numbers: Beh_Act_ETB
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CatherineHarmer, University of Oxford:
behavioural activation
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Mood Disorders
Pathologic Processes
Mental Disorders