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Effects of Behavioural Activation on Emotional Cognition and Mood

Effects of Behavioural Activation on Emotional Cognition and Mood

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03995186
Enrollment
97
Registered
2019-06-21
Start date
2019-02-20
Completion date
2021-09-30
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depressive Disorder, Mood Disorders, Cognition

Keywords

behavioural activation

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.

Interventions

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.

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

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in recognition of positive and negative facial expressions from baseline at week 2 and 4Will be assessed at week 0, week 3 and week 5 of the interventionHit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)

Secondary

MeasureTime frameDescription
Median scores on the daily Mood Zoom questionnaire5 weeksScoring 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 activity5 weeksMotor activity (in Hz) as measured by the GeneActive actigraphy watch
Change in emotional categorisation (ECAT)Will be assessed at week 0, week 3 and week 5 of the interventionReaction times for correctly classifying positive versus negative personality characteristic words
Change in recall in the Emotional memory task (EREC)Will be assessed at week 0, week 3 and week 5 of the interventionNumber of positive and negative words correctly (and incorrectly) recalled in the EREC task
Change in reward sensitivityWill be assessed at week 0, week 3 and week 5 of the interventionSensitivity to reward as measured by the Probabilistic Instrumental Learning Task
Change in performance on Auditory Verbal Learning Task (AVLT)Will be assessed at week 0, week 3 and week 5 of the interventionAccuracy on AVLT (number of items recalled across blocks)
Change in levels of behavioural activationWill be assessed at week 0, week 3 and week 5 of the interventionScore on the Behavioural Activation for Depression Scale (total score range 0-150). Higher scores indicate higher levels of activation.
Change in speed during recognition of positive and negative facial expressionsWill be assessed at week 0, week 3 and week 5 of the interventionReaction times for correctly recognised positive versus negative faces in facial expression recognition task (FERT)
FERT as a possible predictor of mood changeWill be assessed at week 3 and week 5 of the interventionCorrelation between Hit rate on the FERT at week 3 and the change in BDI at week 5
Change in environmental rewardWill be assessed at week 0, week 3 and week 5 of the interventionScore 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 supportWill be assessed at week 0, week 3 and week 5 of the interventionScore on the Multidimensional Scale of Perceived Social Support (total score range 12-84). Higher scores indicate higher levels of support.
Change in anxietyWill be assessed at week 0, week 3 and week 5 of the interventionScore 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 changeWill be assessed at week 3 and week 5 of the interventionCorrelation 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 changeWill be assessed at week 3 and week 5 of the interventionCorrelation between reaction times for correctly classifying positive versus negative personality characteristic words at week 3 and the change in BDI score at week 5
Change in moodWill be assessed at week 0, week 3 and week 5 of the interventionScore on the Beck Depression Inventory (total score range 0-63). Higher scores indicate higher levels of depression.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026