Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
11 Years - 24 Years
Gender
All
More Inclusion & Exclusion 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
N/A
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
University Hospitals Bristol and Weston NHS Foundation Trust
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Sam Amin, MBCHB MSc PhD
Principal Investigator Affiliation
University Hospitals Bristol & Weston NHS Trust
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Other
Overall Status
Active, not recruiting
Countries
United Kingdom
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Tuberous Sclerosis Complex
Additional Details
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 12-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.
Clinical outcomes will be assessed unblinded at baseline, 12, 24 and 48 weeks from
randomisation. As a feasibility and acceptability study a range of physical and mental
health outcomes are assessed. All clinical outcomes focus on health, wellbeing and
quality of life from baseline to 12 week (3-month) follow-up amongst those offered ACT
immediately versus waitlist controls.
Arms & Interventions
Arms
Active Comparator: Allocated to treatment
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.
No Intervention: Allocated to waitlist control
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.
Interventions
Behavioral: - Acceptance and Commitment Therapy (ACT)
Acceptance and commitment therapy (ACT) is an evidence-based psychological therapy that
has been successfully used to improve physical and mental health among children and
adults with chronic conditions. It is a "third wave" cognitive behavioural therapy that
encourages openness to and awareness of the present moment in order to help participants
maintain behaviours consistent with their life goals. ACT fosters engagement with, rather
than avoidance of, painful experiences to move towards acceptance of unchangeable
difficulties alongside building a rich and meaningful life despite the presence of
ongoing difficulties. This gives ACT strong face validity for application to TCS patients
where there can be permanent cognitive impairment and unavoidable ongoing physical
symptoms and functional limitations.
Contact a Trial Team
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