Clinical trial NCT04291547: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Mood
Depression
Keywords: Young people
Lead sponsor: University of York
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 12
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates
timeFrame: 4 months
measure: Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented
timeFrame: 4 months
measure: Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal
timeFrame: 4 months
measure: Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance
timeFrame: 4 months
measure: To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence
timeFrame: 4 months
measure: To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining responses on an evaluation questionnaire
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United Kingdom
facility: Tees Esk and Wear Valleys NHS Foundation Trust
Study officials:
affiliation: University of York
name: Barry Wright
role: STUDY_CHAIR
affiliation: University of York
name: Dean McMillan
role: STUDY_CHAIR
affiliation: Deakin University
name: Antonina Mikocka-Walus
role: STUDY_CHAIR
References: