Computerised Behavioural Activation for Young People With Depression
Primary Purpose
Low Mood, Depression
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
BALM
Sponsored by
About this trial
This is an interventional device feasibility trial for Low Mood focused on measuring Young people
Eligibility Criteria
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
Sites / Locations
- Tees Esk and Wear Valleys NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computerised Behavioural Activation Programme
Arm Description
All recruited young people will be given the BALM (Behavioural Activation for Low Mood) programme to work through
Outcomes
Primary Outcome Measures
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates
Assessed by examining questionnaire response rates
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented
Assessed by examining the percentage of those eligible who consented to the study
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal
Assessed by examining number and reasons for withdrawal
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance
Assessed by examining session attendance
To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence
Assessed by examining session adherence
To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining responses on an evaluation questionnaire
Assessed by examining responses on an evaluation questionnaire comprising 15 short questions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04291547
Brief Title
Computerised Behavioural Activation for Young People With Depression
Official Title
Computerised Behavioural Activation Programme for the Treatment of Depression in Young People: Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this non-randomised feasibility study is to 1) examine the acceptability of a newly developed computerised Behavioural Activation programme (BALM) in treating young people experiencing low mood/depression and 2) assess the feasibility of undertaking a pilot Randomised Controlled Trial (RCT) of the intervention.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Mood, Depression
Keywords
Young people
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerised Behavioural Activation Programme
Arm Type
Experimental
Arm Description
All recruited young people will be given the BALM (Behavioural Activation for Low Mood) programme to work through
Intervention Type
Device
Intervention Name(s)
BALM
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates
Description
Assessed by examining questionnaire response rates
Time Frame
4 months
Title
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented
Description
Assessed by examining the percentage of those eligible who consented to the study
Time Frame
4 months
Title
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal
Description
Assessed by examining number and reasons for withdrawal
Time Frame
4 months
Title
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance
Description
Assessed by examining session attendance
Time Frame
4 months
Title
To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence
Description
Assessed by examining session adherence
Time Frame
4 months
Title
To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining responses on an evaluation questionnaire
Description
Assessed by examining responses on an evaluation questionnaire comprising 15 short questions
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Wright
Organizational Affiliation
University of York
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dean McMillan
Organizational Affiliation
University of York
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antonina Mikocka-Walus
Organizational Affiliation
Deakin University
Official's Role
Study Chair
Facility Information:
Facility Name
Tees Esk and Wear Valleys NHS Foundation Trust
City
York
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Computerised Behavioural Activation for Young People With Depression
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