AnxietyNCT02752945
Feasibility Trial of a One-day CBT Workshop ("DISCOVER") for 15-18 Year Olds With Anxiety and/or Depression in Clinics
A study testing One-day CBT workshop in people with Anxiety and Depression, run by King's College London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- One-day CBT workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Dec 2016
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Foundation Trust
London, BR3 3BX
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- One-day CBT workshop, Usual care
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-day CBT workshopOther
Also called DISCOVER
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.'
Usual careOther
Usual care afforded by local CAMHS services
| Study group | Role | What they receive |
|---|---|---|
| One-day CBT workshop (+Usual Care) | Experimental | One-day CBT-based workshop ("DISCOVER"), followed by up to three brief telephone contacts to review goals set in workshop. Receives: Other: One-day CBT workshop; Other: Usual care |
| Usual care | Active comparator | Usual care afforded by local CAMHS services Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood and Feelings Questionnaire (MFQ)
Assesses symptoms of depression
Measured: 8 weeks
Secondary outcomes (2)
Revised Child Anxiety and Depression Scale (RCADS)
Assesses symptoms of anxiety
Measured: 8 weeks
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Assesses psychological well-being
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Christina E Loucas, BSc, Principal investigator, Institute of Psychiatry, Psychology & Neuroscience, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752945
- Sponsor's protocol ID
- 192806
- Other IDs
- 16/LO/0231, R&D2016/021
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Loucas CE, Sclare I, Stahl D, Michelson D. Feasibility randomized controlled trial of a one-day CBT workshop ('DISCOVER') for 15- to 18-year-olds with anxiety and/or depression in clinic settings. Behav Cogn Psychother. 2020 Mar;48(2):142-159. doi: 10.1017/S1352465819000286. Epub 2019 May 20.
PubMed 31106728
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Randomised Controlled Trial of a One-day CBT Workshop ("DISCOVER") for 15-18 Year Olds With Anxiety and/or Depression in Clinic Settings
- ClinicalTrials.gov ID
- NCT02752945
- Acronym / sponsor ID
- 192806
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Apr 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-day CBT workshop (+Usual Care) | Experimental | Other: One-day CBT workshop, Other: Usual careOne-day CBT-based workshop ("DISCOVER"), followed by up to three brief telephone contacts to review goals set in workshop. |
| Usual care | Active comparator | Other: Usual careUsual care afforded by local CAMHS services |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| One-day CBT workshopAlso: DISCOVEROne-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 | One-day CBT workshop (+Usual Care) |
| Usual careUsual care afforded by local CAMHS services | Other | One-day CBT workshop (+Usual Care), Usual care |
Primary outcome
Mood and Feelings Questionnaire (MFQ)
Time frame: 8 weeks
Assesses symptoms of depression
2 secondary outcomes
Revised Child Anxiety and Depression Scale (RCADS)
Time frame: 8 weeks
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: 8 weeks
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 23 Jan 2020.
- Results publication: PubMed 31106728Loucas CE, Sclare I, Stahl D, Michelson D. Feasibility randomized controlled trial of a one-day CBT workshop ('DISCOVER') for 15- to 18-year-olds with anxiety and/or depression in clinic settings. Behav Cogn Psychother. 2020 Mar;48(2):142-159. doi: 10.1017/S1352465819000286. Epub 2019 May 20.
- Pubmed linkLink provided by the sponsor.
- Study linkLink provided by the sponsor.
- 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.
Christina E Loucas, BSc principal investigator
Institute of Psychiatry, Psychology & Neuroscience, King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-day CBT workshop in people with Anxiety and Depression, run by King's College London 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 5 inclusion and 3 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 23 Jan 2020. 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?
Mood and Feelings Questionnaire (MFQ) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752945, which also lists 1 linked publication.
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 23 Jan 2020.