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Completed

NCT Number: NCT04291547

Computerised Behavioural Activation for Young People With Depression

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.

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Key information

Conditions

Low Mood Behavior Behavioral Symptoms Consciousness Disorders Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tees Esk and Wear Valleys NHS Foundation Trust

York, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BALM

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

Primary outcomes

  1. 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

  2. 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

  3. 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

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

    Time frame: 4 months

    Assessed by examining session attendance

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of York

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2020
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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