Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
Research type
Research Study
Full title
Randomised Controlled Trial of Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
IRAS ID
288638
Contact name
Sam Amin
Contact email
Sponsor organisation
University Hospitals Bristol & Weston NHS Trust
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Tuberous Sclerosis Complex (TSC) is a genetic disease caused by mutations in the tumour suppressor genes TSC1 and TSC2. The clinical hallmarks of the disease are the growth of benign tumours in various organs such as the brain, kidneys and skin. Seizures are present in around 60% of the population and neurodevelopmental problems such as attention deficit disorder and autism are common. Anxiety and depressive disorders are similarly linked and at the psychosocial level, there is increasing evidence of the effect of TSC on self-esteem, family functioning and peer relationships resulting in poorer quality of life. Despite these difficulties, no unique treatments, and almost no effective evidenced psychological treatments for TSC are available.
This trial aims to assess the feasibility and acceptability of Acceptance and Commitment Therapy (ACT) as a psychological treatment to improve quality of life among adolescents and young adults with TSC.
ACT is a cognitive behavioural therapy that helps participants accept difficulties that they are unable to change. There is strong evidence for ACT’s clinical effectiveness amongst patients with chronic diseases. The intervention will be delivered to participants aged 11-24 with TSC and sufficient cognitive and speech capabilities to take part. This will be delivered remotely via secure video-conferencing software. Our primary hypothesis is that ACT will be acceptable and feasible delivered remotely and may yield clinical improvements in health and quality of life.
The study will be a 24-week, waitlist controlled randomised clinical trial. Participants will be randomised to receive 12-weeks treatment either immediately or following a 12-week wait. The treatment will be ACT adapted for 11-24-year-olds who have TSC. Treatment will involve 6 to 12 weekly sessions of ACT of up to one hour each in length. Follow-up assessments will be conducted at 12-, 24 and 48 weeks post-randomisation to measure effectiveness.
REC name
East of England - Essex Research Ethics Committee
REC reference
21/EE/0091
Date of REC Opinion
19 May 2021
REC opinion
Further Information Favourable Opinion