- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02752945
Feasibility Trial of a One-day CBT Workshop ("DISCOVER") for 15-18 Year Olds With Anxiety and/or Depression in Clinics
January 20, 2020 updated by: King's College London
Feasibility Randomised Controlled Trial of a One-day CBT Workshop ("DISCOVER") for 15-18 Year Olds With Anxiety and/or Depression in Clinic Settings
This is a feasibility trial designed to test the feasibility and acceptability of a one-day Cognitive Behavioural Therapy (CBT) workshop intervention ("DISCOVER") for young people aged between 15-18 years, who are on local child and adolescent mental health services (CAMHS) waiting lists, awaiting treatment for difficulties with anxiety and/or depression.
Participants will be randomised to receive either the DISCOVER workshop (in addition usual care) or to continue usual care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sclare and colleagues (2015) have developed an open-access intervention ("DISCOVER") for 16-18 year olds experiencing emotional problems, in the form of one-day CBT-based workshops, delivered in schools.
DISCOVER has been tested in schools and preliminary outcomes have shown to be positive.
Given the lengthy waiting lists of some CAMHS services, the present study seeks to explore whether the DISCOVER programme can be implemented in clinic settings, with a broader age range of 15-18 year olds, with the aim of providing young people with some form of help, whilst they are awaiting more individualised treatment.
Fifteen to eighteen year olds awaiting treatment for anxiety and/or depression will be recruited from local CAMHS waiting lists, and randomised to receive either the DISCOVER workshop, delivered in clinic (in addition to usual care), or to continue usual care.
The study will assess the feasibility, acceptability and range of outcomes of DISCOVER in clinic settings.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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London, United Kingdom, BR3 3BX
- South London and Maudsley NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 15-18 years;
- fluent in English;
- currently on a local CAMHS waiting list for treatment based on a referral for emotional difficulties (anxiety and/or depression);
- willing and able to attend a one-day workshop within clinic; and
- their position on the waiting list must indicate that they are unlikely to receive a CAMHS treatment appointment in the 8 weeks following the workshop.
Exclusion Criteria:
- presenting with acute risk of harm to self or others;
- have severe learning difficulties; and
- are unable to provide informed written consent to participate and are unable to complete assessments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: One-day CBT workshop (+Usual Care)
One-day CBT-based workshop ("DISCOVER"), followed by up to three brief telephone contacts to review goals set in workshop.
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One-day long CBT workshop, with between 4-15 participants, facilitated by clinical psychologists.
Following introductions, ice breakers and an explanation of the CBT model, CBT techniques are then introduced and practised using a variety of methods.
One week after the workshop, any personal goals set during the workshop are reviewed with one of the workshop facilitators in a 'telephone goal review.'
Other Names:
Usual care afforded by local CAMHS services
|
|
ACTIVE_COMPARATOR: Usual care
Usual care afforded by local CAMHS services
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Usual care afforded by local CAMHS services
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood and Feelings Questionnaire (MFQ)
Time Frame: 8 weeks
|
Assesses symptoms of depression
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Child Anxiety and Depression Scale (RCADS)
Time Frame: 8 weeks
|
Assesses symptoms of anxiety
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8 weeks
|
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Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time Frame: 8 weeks
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Assesses psychological well-being
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christina E Loucas, BSc, Institute of Psychiatry, Psychology & Neuroscience, King's College London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2016
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
April 14, 2016
First Submitted That Met QC Criteria
April 25, 2016
First Posted (ESTIMATE)
April 27, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 23, 2020
Last Update Submitted That Met QC Criteria
January 20, 2020
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 192806
- 16/LO/0231 (OTHER: NHS Ethics Reference)
- R&D2016/021 (OTHER: NHS Trust approval)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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