NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Conditions: Tuberous Sclerosis Complex
Interventions: Acceptance and Commitment Therapy (ACT)
Countries: United Kingdom
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.
Sex: ALL
Age: 11 Years to 24 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Bristol, United Kingdom