DepressionNCT03995186
Effects of Behavioural Activation on Emotional Cognition and Mood
A study testing Behavioural activation and Activity monitoring in people with Depression and Depressive Disorder, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Depressive Disorder, Mood Disorders
- What is being tested?
- Behavioural activation and Activity monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male
- Age: 18 to 65 years
- Competency to give informed consent
- Scores above 14 on BDI-2 (bottom criterion for mild depression)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression, Depressive Disorder, Mood Disorders, Cognition
- Being tested
- Behavioural activation, Activity monitoring
- Keywords
- behavioural activation
- Medical subject headings
- Depression, Depressive Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural activationBehavioural
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 monitoringBehavioural
4-week programme where participants simply monitor their general daily activities in a diary.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural activation group | Experimental | Not described Receives: Behavioral: Behavioural activation |
| Activity monitoring group | Active comparator | Not described Receives: Behavioral: Activity monitoring |
| Waiting list control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
Secondary outcomes (16)
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.
Measured: 5 weeks
Motor activity
Motor activity (in Hz) as measured by the GeneActive actigraphy watch
Measured: 5 weeks
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)
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
Change in emotional categorisation (ECAT)
Reaction times for correctly classifying positive versus negative personality characteristic words
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
Change in recall in the Emotional memory task (EREC)
Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
Change in reward sensitivity
Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
Change in performance on Auditory Verbal Learning Task (AVLT)
Accuracy on AVLT (number of items recalled across blocks)
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
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.
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
Change in mood
Score on the Beck Depression Inventory (total score range 0-63). Higher scores indicate higher levels of depression.
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
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
Measured: Will be assessed at week 3 and week 5 of the intervention
Change in environmental reward
Score on the Environmental reward observation scale (total score range 10-40). Higher scores indicate higher levels of environmental reward.
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
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.
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
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.
Measured: Will be assessed at week 0, week 3 and week 5 of the intervention
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
Measured: Will be assessed at week 3 and week 5 of the intervention
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
Measured: Will be assessed at week 3 and week 5 of the intervention
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
Measured: Will be assessed at week 3 and week 5 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start20 Feb 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Harmer, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995186
- Sponsor's protocol ID
- Beh_Act_ETB
- Status last verified
- May 2023
- First submitted
- 23 Apr 2019
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Behavioural Activation on Emotional Cognition and Mood
- ClinicalTrials.gov ID
- NCT03995186
- Acronym / sponsor ID
- Beh_Act_ETB
- Conditions
- Depression, Depressive Disorder, Mood Disorders, Cognition
- Keywords
- behavioural activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behavioural activation group | Experimental | Behavioral: Behavioural activation |
| Activity monitoring group | Active comparator | Behavioral: Activity monitoring |
| Waiting list control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male
- Age: 18 to 65 years
- Competency to give informed consent
- Scores above 14 on BDI-2 (bottom criterion for mild depression)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural activation4-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. | Behavioural | Behavioural activation group |
| Activity monitoring4-week programme where participants simply monitor their general daily activities in a diary. | Behavioural | Activity monitoring group |
Primary outcome
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)
16 secondary outcomes
Median scores on the daily Mood Zoom questionnaire
Time frame: 5 weeks
Motor activity
Time frame: 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
Change in emotional categorisation (ECAT)
Time frame: 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
Change in reward sensitivity
Time frame: 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
Change in levels of behavioural activation
Time frame: 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
FERT as a possible predictor of mood change
Time frame: 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
Change in subjective experience of social support
Time frame: 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
EREC as a possible predictor of mood change
Time frame: 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
FERT as a possible predictor of mood change
Time frame: Will be assessed at week 3 and week 5 of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural activation and Activity monitoring in people with Depression and Depressive Disorder, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.