Computerised Behavioural Activation for Young People With Depression

Not Applicable

Completed

• Conditions: Low Mood; Depression
• Interventions: Device: BALM

• Registration Number: NCT04291547
• Lead Sponsor: University of York

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.

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Study Start: 2020-06-10
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computerised Behavioural Activation Programme	BALM	All recruited young people will be given the BALM (Behavioural Activation for Low Mood) programme to work through

Primary Outcome Measures

Name	Time	Method
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented	4 months	Assessed by examining the percentage of those eligible who consented to the study
To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining responses on an evaluation questionnaire	4 months	Assessed by examining responses on an evaluation questionnaire comprising 15 short questions
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates	4 months	Assessed by examining questionnaire response rates
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance	4 months	Assessed by examining session attendance
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal	4 months	Assessed by examining number and reasons for withdrawal
To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence	4 months	Assessed by examining session adherence

Trial Locations

Locations (1)

Tees Esk and Wear Valleys NHS Foundation Trust; 🇬🇧 York, United Kingdom