Multi-component anxiety management programme for people with intellectual disability
| ISRCTN | ISRCTN16062949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16062949 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 315557 |
| Protocol serial number | CPMS 55443, IRAS 315557, NIHR 204370 |
| Sponsor | Cheshire and Wirral Partnership NHS Foundation Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 25/07/2023
- Registration date
- 31/07/2023
- Last edited
- 04/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This research project is about trying a novel treatment to help people to manage their anxiety. We have developed an anxiety management treatment with people who have an intellectual disability and we want to investigate if this treatment helps people manage their anxiety.
There are an estimated 1.5 million people in England with an intellectual disability, with nearly half of people experiencing some difficulty with anxiety. The effect anxiety can have on a person’s life can be significant which can result in increased medication being prescribed to help the person cope with their mental health. There are not many effective therapies available that can help and support people with self-management of their
anxiety. People with intellectual disabilities can develop these skills, but need adapted therapies to develop and retain self -management skills. For people who have a more severe intellectual disability and have difficulty with their communication, anxiety can be demonstrated through difficult behaviour, resulting in higher levels of medication being prescribed. There is some evidence which suggests that adapting therapies to help people with their anxiety can be effective, but this is limited to a single psychological therapy approach with no evidence of any long-term effects. We have developed an anxiety management programme using a range of different psychological therapies.
Who can participate?
Adults over 18 years, with intellectual disabilities.
What does the study involve?
This research project will include 60 people with intellectual disabilities. We will test our treatment with 30 people. A separate 30 people will receive a different therapy treatment called cognitive behaviour therapy (treatment as usual). Both of the treatments will be for people with intellectual disability who suffer with anxiety. We will use outcome measures to understand the treatment effects and any differences between groups. We will obtain feedback from participants using interviews to make improvements to the anxiety management programme.
What are the possible benefits and risks of participating?
The study poses minimal risk to participants. In our development group, the participants identified the current CBT based practices as being often difficult to follow but recognised effective components within this therapy. The multi-component anxiety management programme in question has been designed to be more accessible than the treatment currently available.
Where is the study run from?
Cheshire and Wirral Partnership NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2023 to March 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Daniel Acton (Clinical Nurse Specialist), danny.acton@nhs.net
Contact information
Principal investigator
Cheshire and Wirral Partnership NHS Foundation Trust
Liverpool Road
Chester
CH2 1BQ
United Kingdom
 ORCID ID |
0000-0001-9989-8225 |
|---|---|
| Phone | +44 1244 397397 |
| danny.acton@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre feasibility study for a single blind randomized controlled quasi-experimental trial of a novel multi-component anxiety management intervention in comparison to treatment as usual |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 44000_PIS_V1.5_06Mar23.pdf |
| Scientific title | Evaluation of a novel multi-component anxiety management programme: a mixed methods quasi-experimental feasibility study |
| Study acronym | M CAMP-ID |
| Study objectives | Is it feasible to evaluate the effectiveness of a novel multi component anxiety management treatment programme in reducing levels of anxiety in people with intellectual disability within a randomised control trial study design? |
| Ethics approval(s) |
Approved 23/03/2023, East Midlands - Derby Research Ethic Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 207 104 8154; derby.rec@hra.nhs.uk), ref: 23/EM/0044 |
| Health condition(s) or problem(s) studied | Anxiety |
| Intervention | Sixty people with intellectual disability will be invited to participate in the study across four intellectual disability services within one mental health trust in England. The specialist services will be randomly selected to deliver either treatment as usual (TAU) or the novel intervention (M CAMP-ID). M CAMP-ID comprises of ten individual sessions delivered by a member of the clinical team once a week for between 10 – 12 weeks. Patients will be followed up for 20 weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
Levels of anxiety measured using the Glasgow Anxiety scale (GAS-ID) at baseline, 12 and 20 weeks |
| Key secondary outcome measure(s) |
1. Anxiety and mood measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 12 and 20 weeks |
| Completion date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Participants aged over 18 years of age. 2. Registered diagnosis of mild or moderate intellectual disability with or without autism. 3. Scores above seven (range 7-18) on the anxiety component on the MOSS Pas-ID (Moss et al., 1998). 4. Required to provide informed consent and sign a declaration form indicating agreement to participate. |
| Key exclusion criteria | 1. If they choose not to be involved in the study. 2. Have a severe or profound intellectual disability. 3. Lack capacity to consent. 4. Under the age of 18 years old. 5. Participants who score below 7 on the anxiety component of the Moss PAS-ID. |
| Date of first enrolment | 30/03/2023 |
| Date of final enrolment | 31/08/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Countess of Chester Health Park
Liverpool Road
Chester
CH2 1BQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 20/09/2023 | 21/09/2023 | Yes | No | |
| Participant information sheet | version 1.5 | 06/03/2023 | 28/07/2023 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 44000_PIS_V1.5_06Mar23.pdf
- Participant information sheet
Editorial Notes
04/04/2025: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The study website was added.
3. The participant level data sharing statement was added.
03/10/2023: Internal review.
21/09/2023: Publication reference added.
28/07/2023: Study's existence confirmed by the HRA.
