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Clinical Trials/NCT04291547
NCT04291547
Completed
Not Applicable

Computerised Behavioural Activation Programme for the Treatment of Depression in Young People: Feasibility Study

University of York1 site in 1 country12 target enrollmentJune 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Mood
Sponsor
University of York
Enrollment
12
Locations
1
Primary Endpoint
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2020
End Date
March 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of York
Responsible Party
Principal Investigator
Principal Investigator

Lucy Tindall

Principal Investigator

University of York

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

Outcomes

Primary Outcomes

Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented

Time Frame: 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

Time Frame: 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

Time Frame: 4 months

Assessed by examining questionnaire response rates

Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance

Time Frame: 4 months

Assessed by examining session attendance

Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal

Time Frame: 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

Time Frame: 4 months

Assessed by examining session adherence

Study Sites (1)

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