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Effects of Behavioural Activation on Emotional Cognition and Mood

Primary Purpose

Depression, Depressive Disorder, Mood Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behavioural activation
Activity monitoring
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring behavioural activation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Oxford

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Behavioural activation group

Activity monitoring group

Waiting list control group

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Motor activity
Motor activity (in Hz) as measured by the GeneActive actigraphy watch
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)
Change in emotional categorisation (ECAT)
Reaction times for correctly classifying positive versus negative personality characteristic words
Change in recall in the Emotional memory task (EREC)
Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Change in reward sensitivity
Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task
Change in performance on Auditory Verbal Learning Task (AVLT)
Accuracy on AVLT (number of items recalled across blocks)
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.
Change in mood
Score on the Beck Depression Inventory (total score range 0-63). Higher scores indicate higher levels of depression.
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
Change in environmental reward
Score on the Environmental reward observation scale (total score range 10-40). Higher scores indicate higher levels of environmental reward.
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.
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.
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
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
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

Full Information

First Posted
April 23, 2019
Last Updated
May 9, 2023
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT03995186
Brief Title
Effects of Behavioural Activation on Emotional Cognition and Mood
Official Title
Effects of Behavioural Activation on Emotional Cognition and Mood
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Mood Disorders, Cognition
Keywords
behavioural activation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioural activation group
Arm Type
Experimental
Arm Title
Activity monitoring group
Arm Type
Active Comparator
Arm Title
Waiting list control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Behavioural activation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Activity monitoring
Intervention Description
4-week programme where participants simply monitor their general daily activities in a diary.
Primary Outcome Measure Information:
Title
Change in recognition of positive and negative facial expressions from baseline at week 2 and 4
Description
Hit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary Outcome Measure Information:
Title
Median scores on the daily Mood Zoom questionnaire
Description
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.
Time Frame
5 weeks
Title
Motor activity
Description
Motor activity (in Hz) as measured by the GeneActive actigraphy watch
Time Frame
5 weeks
Title
Change in speed during recognition of positive and negative facial expressions
Description
Reaction times for correctly recognised positive versus negative faces in facial expression recognition task (FERT)
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
Change in emotional categorisation (ECAT)
Description
Reaction times for correctly classifying positive versus negative personality characteristic words
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
Change in recall in the Emotional memory task (EREC)
Description
Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
Change in reward sensitivity
Description
Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
Change in performance on Auditory Verbal Learning Task (AVLT)
Description
Accuracy on AVLT (number of items recalled across blocks)
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
Change in levels of behavioural activation
Description
Score on the Behavioural Activation for Depression Scale (total score range 0-150). Higher scores indicate higher levels of activation.
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
Change in mood
Description
Score on the Beck Depression Inventory (total score range 0-63). Higher scores indicate higher levels of depression.
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
FERT as a possible predictor of mood change
Description
Correlation between Hit rate on the FERT at week 3 and the change in BDI at week 5
Time Frame
Will be assessed at week 3 and week 5 of the intervention
Title
Change in environmental reward
Description
Score on the Environmental reward observation scale (total score range 10-40). Higher scores indicate higher levels of environmental reward.
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
Change in subjective experience of social support
Description
Score on the Multidimensional Scale of Perceived Social Support (total score range 12-84). Higher scores indicate higher levels of support.
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
Change in anxiety
Description
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.
Time Frame
Will be assessed at week 0, week 3 and week 5 of the intervention
Title
EREC as a possible predictor of mood change
Description
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
Time Frame
Will be assessed at week 3 and week 5 of the intervention
Title
ECAT as a possible predictor of mood change
Description
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
Time Frame
Will be assessed at week 3 and week 5 of the intervention
Title
FERT as a possible predictor of mood change
Description
Correlation between Reaction times on the FERT at week 3 and the change in BDI at week 5
Time Frame
Will be assessed at week 3 and week 5 of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Behavioural Activation on Emotional Cognition and Mood

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