Clinical trial · Interventional
Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
Randomised Controlled Trial of Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Allocated to treatment
- description
- Patients randomly allocated to this arm will receive treatment immediately. They will receive 6-12 sessions of ACT while patients allocated to the waitlist control arm do no receive any treatment.
- interventionNames
- Behavioral: Acceptance and Commitment Therapy (ACT)
- type
- NO_INTERVENTION
- label
- Allocated to waitlist control
- description
- Patients randomly allocated to this arm will receive a delay in the treatment they receive. After a 12-week wait they will receive 6-12 sessions of ACT, while patients allocated to the immediate treatment arm receive no treatment for an equal duration.
Primary outcomes (8)
- measure
- Treatment completion rate
- timeFrame
- Assessed at 3-month follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 11 Years
- Maximum age
- 24 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available