- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04291547
Computerised Behavioural Activation for Young People With Depression
Computerised Behavioural Activation Programme for the Treatment of Depression in Young People: Feasibility Study
Study Overview
Detailed Description
Approximately 20% of adolescents will have had at least one depressive episode by the age of 18 making depression one of the leading causes of illness and disability in young people. Although receiving effective treatment is important, as few as 35% of young people seek help, with treatment-related issues (e.g. stigma, negative attitudes about help-seeking, accessibility, reluctance to engage one-to-one with a therapist, etc) outlined as reasons for this. Computerised therapies, which have increased availability and accessibility, reduced stigma and can be delivered in a format attractive to many young people may avoid some of these barriers and provide a more effective treatment option for young people.
Behavioural Activation (BA) - a type of talking therapy focused on increasing liked activities has demonstrated effectiveness in treating depression in adults and, owing to this, is an evidence-based treatment for depression within NICE (2009) guidelines. Despite this, less research has examined its use with young people.
We have developed BALM (Behavioural Activation for Low Mood), an online BA programme designed for use with young people experiencing mild to moderate low mood or depression. The development of BALM was based upon the findings of a systematic review and a series of qualitative interviews and focus groups with young people and healthcare professionals.
Eligible young people will be referred to the programme via healthcare professionals working in local Child and Adolescent Mental Health Services and mental health practitioners based in local secondary schools.
The findings of this research will allow us to refine the intervention and the research methods we employ in preparation for a pilot randomised controlled trial (RCT) of the new treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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York, United Kingdom
- Tees Esk and Wear Valleys NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 11 to 16 years at the date of consent
- Experiencing low mood or depression symptoms as defined by a score of ≥20 on the Mood and Feelings Questionnaire
- In agreement that their primary care provider and a parent/guardian can be informed of any concerns the lead researcher has about their wellbeing during participation
Exclusion Criteria:
- Within the normal range on the measure of depressive symptoms (i.e. attaining a score of ≤19 on the Mood and Feelings Questionnaire)
- Experiencing severe low mood or depression symptoms
- Having a comorbid mental health diagnosis of Bipolar Disorder or Psychosis.
- Non-English speaking (due to the small scope of this study, the option of providing translated versions of BALM and the outcome measures was not feasible)
- Deemed to be actively at risk of self harm or suicide
- Have no access to the internet and therefore no programme access
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computerised Behavioural Activation Programme
All recruited young people will be given the BALM (Behavioural Activation for Low Mood) programme to work through
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An online Behavioural Activation programme for young people with mild to moderate low mood/depression.
The programme comprises 10 treatment sessions lasting 30 to 45 minutes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates
Time Frame: 4 months
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Assessed by examining questionnaire response rates
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4 months
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Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented
Time Frame: 4 months
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Assessed by examining the percentage of those eligible who consented to the study
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4 months
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Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal
Time Frame: 4 months
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Assessed by examining number and reasons for withdrawal
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4 months
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Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance
Time Frame: 4 months
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Assessed by examining session attendance
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4 months
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To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence
Time Frame: 4 months
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Assessed by examining session adherence
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4 months
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To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining responses on an evaluation questionnaire
Time Frame: 4 months
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Assessed by examining responses on an evaluation questionnaire comprising 15 short questions
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4 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Barry Wright, University of York
- Study Chair: Dean McMillan, University of York
- Study Chair: Antonina Mikocka-Walus, Deakin University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 270172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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