Computerised Behavioural Activation for Young People With Depression

NCT ID: NCT04291547

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-10
• Study Completion Date: 2021-03-31

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.

Conditions

Low Mood; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Computerised Behavioural Activation Programme

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

Group Type: EXPERIMENTAL

BALM

Intervention Type: DEVICE

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

Interventions

BALM

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of York

OTHER

Sponsor Role: lead

Responsible Party

Lucy Tindall

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry Wright

Role: STUDY_CHAIR

University of York

Dean McMillan

Role: STUDY_CHAIR

University of York

Antonina Mikocka-Walus

Role: STUDY_CHAIR

Deakin University

Locations

Tees Esk and Wear Valleys NHS Foundation Trust

York, , United Kingdom

Countries

United Kingdom

Other Identifiers

270172

Identifier Type: -

Identifier Source: org_study_id