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Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
Acceptance and Commitment Therapy in Tuberous Sclerosis Complex

NCT05867576

UnknownNA

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.

Eligibility overview

Sex: ALL

Age: 11 Years to 24 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Bristol, United Kingdom