| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression Depressive Disorder Mood Disorders Cognition | Behavioral: Behavioural activation Behavioral: Activity monitoring | Not Applicable |
| 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 |
| 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.
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| Active Comparator: Activity monitoring group |
Behavioral: Activity monitoring
4-week programme where participants simply monitor their general daily activities in a diary.
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| No Intervention: Waiting list control group |
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Catherine Harmer, DPhil | +44 (0)1865 618326 | catherine.harmer@psych.ox.ac.uk | |
| Contact: Susannah Murphy, DPhil | susannah.murphy@psych.ox.ac.uk |
| United Kingdom | |
| University of Oxford | Recruiting |
| Oxford, United Kingdom, OX3 7JX | |
| Contact: Catherine Harmer, Professor | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 23, 2019 | ||||
| First Posted Date ICMJE | June 21, 2019 | ||||
| Last Update Posted Date | June 21, 2019 | ||||
| Actual Study Start Date ICMJE | February 20, 2019 | ||||
| Estimated Primary Completion Date | March 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Behavioural Activation on Emotional Cognition and Mood | ||||
| Official Title ICMJE | Effects of Behavioural Activation on Emotional Cognition and Mood | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | 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 |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
120 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | March 30, 2021 | ||||
| Estimated Primary Completion Date | March 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03995186 | ||||
| Other Study ID Numbers ICMJE | Beh_Act_ETB | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | CatherineHarmer, University of Oxford | ||||
| Study Sponsor ICMJE | University of Oxford | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | University of Oxford | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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