Kent and Medway Mental Health NHS Trust
Maidstone, ME16 9PH, United Kingdom
NCT Number: NCT07630376
The goal of this clinical trial is to examine the feasibility and acceptability of a brief guided self-help wellbeing intervention for autistic adults accessing UK secondary mental health services. The study also aims to begin to evaluate whether use of the workbook is associated with any changes in wellbeing. The main questions it aims to answer are:
1. Is it feasible to recruit and retain autistic adults to participate in the study? 2. Do participants find the workbook acceptable and relevant? 3. Are there measurable improvements in wellbeing following workbook use? 4. What changes, if any, do participants recommend for future versions of the intervention?
Participants will:
* Take part in 4-6 sessions of 30-60 minutes using the guided self-help workbook with the support of a trained National Health Service support worker, assistant psychologist, or mental health professional * Complete wellbeing questionnaires before, during, and after using the workbook * Complete brief daily wellbeing ratings throughout the study * Take part in a 1:1 semi-structured interview of up to an hour to discuss their experience of the workbook
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Maidstone, ME16 9PH, United Kingdom
Autism is a lifelong neurodevelopmental difference that affects how people communicate, experience the world, and relate to others. In the UK, more than 1% of people are estimated to be autistic, with rates of diagnosis rapidly increasing. Many autistic adults experience mental health challenges such as anxiety, depression, and suicidal thoughts. Some may experience 'autistic burnout', a state of deep exhaustion and loss of coping ability. These difficulties can result from long-term stress, 'masking' (hiding autistic traits to fit in), and lack of understanding or support.
In the UK National Health Service, post-diagnostic support for autistic adults is limited, often consisting only of information or signposting. While existing psychological therapies can help with anxiety and depression, they are not always designed with the needs of autistic people in mind. This highlights a clear need for preventative, accessible, and autism-specific wellbeing support, especially within the National Health Service, where demand is high and resources are limited.
This study aims to explore whether a new guided self-help wellbeing workbook designed specifically for autistic adults is feasible and acceptable, and to get an initial impression of its helpfulness in improving wellbeing. It focuses on helping people to understand autism and manage their energy levels using 'energy accounting' (Toudal & Attwood, 2024), and to plan for wellbeing using personalised strategies. The aim is to help autistic adults improve self-understanding, communicate their needs, and enhance wellbeing in everyday life.
The study will have three phases (baseline: a 1-2 week period prior to completing the workbook; intervention: a 4-6 week period during completion of the workbook; follow-up: a 3-4 week period following workbook completion). Participants will be asked to complete standardised questionnaires at the beginning and end of each phase. Brief daily wellbeing ratings will be collected throughout all three phases. Finally, an interview of up to an hour will be conducted with participants at the end of the follow-up phase.
There are six primary indicators which will be compared against pre-specified progression criteria. The primary outcomes are 1) ease of recruitment to the study; 2) participant retention in the intervention; 3) participant retention in the study; 4) intervention acceptability; 5) outcome measure completion; 6) whether there is a preliminary indicator of efficacy on the primary outcome measure (wellbeing). Progression criteria will be used to help decide whether the research should progress to more powered intervention studies in future.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The workbook's components are: psycho-education and energy accounting (Toudal & Attwood, 2024) - including sensory awareness - and planning for wellbeing. It will be delivered over four to six sessions of between 30-60 minutes each with a trained National Health Service support worker, assistant psychologist, or mental health professional. Sessions would be conducted in-person, via telephone, or via video.
Time frame: 6 months following start of recruitment
The number of participants recruited over 6 months will be compared against the following progression criterion to assess the feasibility of recruitment: Green: 8-10; Amber: 6-7; Red: <5
Time frame: Weeks 2-8
The proportion of participants who complete the guided self-help intervention will be compared against the following progression criterion to assess retention in the intervention: Green: ≥75%; Amber: ≥50%; Red: <50%
Time frame: Weeks 0-12
The proportion of study participants who remain in the study will be compared against the following progression criterion to assess retention in the study: Green: ≥75%; Amber: ≥50%; Red: <50%
Time frame: Weeks 11-12
Response to Likert type questions and thematic analysis of qualitative data will be compared against the following progression criterion to assess retention in the study: Green: the majority of participants report the intervention is acceptable as it is or with minor adjustments; Amber: there are inconsistent reports of acceptability or the intervention requires bigger adjustments; Red: the majority of participants report the intervention is unacceptable or requires adjustments which cannot be completed
Time frame: Weeks 0-12
The rate of the outcome measures completion will be compared against the following progression criterion to assess the feasibility of outcome measurement: Green: ≥75%; Amber ≥50%; Red: <50%
Time frame: Baseline (weeks 0-1) and post-intervention (weeks 7-8)
The ReQoL-20 contains 20 items measuring quality of life, with higher scores indicating greater quality of life.
The proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to post-intervention (weeks 7-8) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: ≥75%; Amber: ≥50%; Red: <50%
Time frame: Baseline (weeks 0-1) and follow-up (weeks 11-12)
The ReQoL-20 contains 20 items measuring quality of life, with higher scores indicating greater quality of life.
The proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to follow-up (weeks 11-12) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: ≥75%; Amber: ≥50%; Red: <50%
Time frame: Baseline (weeks 0-1) and post-intervention (weeks 7-8)
The DIALOG scale contains 11 items measuring quality of life and treatment satisfaction, with higher scores indicating greater satisfaction.
The proportion of participants showing reliable improvement on the DIALOG from baseline (weeks 0-1) to post-intervention (weeks 7-8) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: ≥75%; Amber: ≥50%; Red: <50%
Time frame: Baseline (weeks 0-1) and follow-up (weeks 11 to 12)
The DIALOG scale contains 11 items measuring quality of life and treatment satisfaction, with higher scores indicating greater satisfaction.
The proportion of participants showing reliable improvement on the DIALOG from baseline (weeks 0-1) to follow-up (weeks 11-12) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: ≥75%; Amber: ≥50%; Red: <50%
Time frame: Baseline (weeks 0-1) to post-intervention (weeks 7-8)
Brief daily wellbeing ratings (e.g. 'rate your wellbeing on a scale of 0-10') will be collected throughout all phases (baseline, intervention, follow-up) to provide additional time-linked data to evaluate intervention efficacy
Time frame: Baseline (weeks 0-1) to follow-up (weeks 11-12)
Brief daily wellbeing ratings (e.g. 'rate your wellbeing on a scale of 0-10') will be collected throughout all phases (baseline, intervention, follow-up) to provide additional time-linked data to evaluate intervention efficacy
Time frame: Weeks 11-12
An interview of up to an hour will be conducted with participants at the end of the follow-up phase to explore their experiences of using the workbook
Contact information is provided by the study sponsor or research team.
Fergal Jones
CONTACT
Kirsten Mann
CONTACT
Canterbury Christ Church University
Other
Evaluating the Use of a Guided Self-help Workbook to Promote Wellbeing for Autistic Adults: A Mixed-methods Multiple Single-case Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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