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Completed

NCT Number: NCT03995186

Effects of Behavioural Activation on Emotional Cognition and Mood

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Cognition Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oxford

Oxford, OX3 7JX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Behavioural Activation

Behavioral

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.

Activity Monitoring

Behavioral

4-week programme where participants simply monitor their general daily activities in a diary.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2019
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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