Acceptance and Commitment Therapy in Tuberous Sclerosis Complex (NCT05867576) | Clinical Trial Compass
UnknownNot Applicable
Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
United Kingdom15 participantsStarted 2021-08-12
Plain-language summary
The study will assess the acceptability and feasibility of a randomised controlled trial of 6-12 sessions of remotely-delivered Acceptance and Commitment Therapy (ACT) versus waitlist control. Waitlist control will involve a delay in the offer of ACT sessions for 12 weeks. Participants may access all services as usual in this time. Follow-up assessments will be conducted at 12-, 24 and 48 weeks post-randomisation to measure effectiveness.
Who can participate
Age range
11 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 11 to 24 years.
* Diagnosis of Tuberous Sclerosis Complex.
* Sufficient understanding of English to engage with the intervention (spoken and written), as judged by the assessing clinician.
* Sufficient cognitive, sensory and speech capabilities to take part in the intervention.
* Participants (or their parents if under 16) give verbal or written informed consent to participate in the study.
* Participants give verbal or written assent if under 16.
* Receiving treatment over video-conferencing will be the default modality for delivery, so access to the internet is a requirement.
Exclusion Criteria:
* Previous structured behavioural intervention within last 6 months.
* Previous or current alcohol/substance dependence, psychosis, suicidality, or anorexia nervosa.
* Moderate or severe intellectual disability.
* Immediate risk to self or others.
* Parent or child not able to speak, read or write English.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment completion rate
Timeframe: Assessed at 3-month follow-up.
2
Treatment completion rate
Timeframe: Assessed at 6-month follow-up
3
Session attendance rate
Timeframe: Assessed at 3-month follow-up
4
Session attendance rate
Timeframe: Assessed at 6-month follow-up
5
The credibility/expectancy questionnaire
Timeframe: Assessed at baseline
6
The credibility/expectancy questionnaire
Timeframe: Assessed at session 2
7
The experience of service questionnaire
Timeframe: Assessed at 3-month follow-up
8
The experience of service questionnaire
Trial details
NCT IDNCT05867576
SponsorUniversity Hospitals Bristol and Weston NHS Foundation Trust