Depression Clinical Trial
Official title:
Computerised Behavioural Activation Programme for the Treatment of Depression in Young People: Feasibility Study
NCT number | NCT04291547 |
Other study ID # | 270172 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 10, 2020 |
Est. completion date | March 31, 2021 |
Verified date | April 2021 |
Source | University of York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Tees Esk and Wear Valleys NHS Foundation Trust | York |
Lead Sponsor | Collaborator |
---|---|
University of York |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates | Assessed by examining questionnaire response rates | 4 months | |
Primary | 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 | 4 months | |
Primary | 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 | 4 months | |
Primary | Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance | Assessed by examining session attendance | 4 months | |
Primary | To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence | Assessed by examining session adherence | 4 months | |
Primary | 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 | 4 months |
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