Low MoodNCT04291547
Computerised Behavioural Activation for Young People With Depression
A study testing BALM in people with Low Mood and Depression, run by University of York at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Low Mood, Depression
- What is being tested?
- BALM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Tees Esk and Wear Valleys NHS Foundation Trust
York
About this study
Official title: Computerised Behavioural Activation Programme for the Treatment of Depression in Young People: Feasibility Study
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.
Read the 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
- Being tested
- BALM
- Keywords
- Young people
- Medical subject headings
- Consciousness Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Computerised Behavioural Activation Programme | Experimental | All recruited young people will be given the BALM (Behavioural Activation for Low Mood) programme to work through Receives: Device: BALM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates
Assessed by examining questionnaire response rates
Measured: 4 months
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented
Assessed by examining the percentage of those eligible who consented to the study
Measured: 4 months
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal
Assessed by examining number and reasons for withdrawal
Measured: 4 months
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance
Assessed by examining session attendance
Measured: 4 months
To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence
Assessed by examining session adherence
Measured: 4 months
To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining responses on an evaluation questionnaire
Assessed by examining responses on an evaluation questionnaire comprising 15 short questions
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start10 Jun 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy Tindall, University of York
- Investigators
- Barry Wright, Study chair, University of YorkDean McMillan, Study chair, University of YorkAntonina Mikocka-Walus, Study chair, Deakin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291547
- Sponsor's protocol ID
- 270172
- Status last verified
- Apr 2021
- First submitted
- 25 Feb 2020
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerised Behavioural Activation Programme for the Treatment of Depression in Young People: Feasibility Study
- ClinicalTrials.gov ID
- NCT04291547
- Acronym / sponsor ID
- 270172
- Conditions
- Low Mood, Depression
- Keywords
- Young people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of YorkUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerised Behavioural Activation Programme | Experimental | Device: BALMAll recruited young people will be given the BALM (Behavioural Activation for Low Mood) programme to work through |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BALMAn 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 | Device | Computerised Behavioural Activation Programme |
Primary outcome
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 the percentage of those eligible who consented
Time frame: 4 months
Assessed by examining the percentage of those eligible who consented to the study
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
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance
Time frame: 4 months
Assessed by examining session attendance
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Wright study chair
University of York
Dean McMillan study chair
University of York
Antonina Mikocka-Walus study chair
Deakin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALM in people with Low Mood and Depression, run by University of York at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.