Clinical trial NCT05867576: Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
Official title: Randomised Controlled Trial of Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tuberous Sclerosis Complex
Keywords: Tuberous Sclerosis Complex
Acceptance and Commitment Therapy
Mental Health
Psychology
Paediatrics
Neurology
Remote therapy
TAND
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The Tuberous Sclerosis Association
name: University College, London
First posted: 2023-05-22
Enrollment: 15
Sex: ALL
Minimum age (years): 11
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised controlled trial of 6-12 sessions of ACT versus waitlist control. Waitlist control will involve a delay in the offer of ACT sessions for 12 weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Treatment completion rate
timeFrame: Assessed at 3-month follow-up.
measure: Treatment completion rate
timeFrame: Assessed at 6-month follow-up
measure: Session attendance rate
timeFrame: Assessed at 3-month follow-up
measure: Session attendance rate
timeFrame: Assessed at 6-month follow-up
measure: The credibility/expectancy questionnaire
timeFrame: Assessed at baseline
measure: The credibility/expectancy questionnaire
timeFrame: Assessed at session 2
measure: The experience of service questionnaire
timeFrame: Assessed at 3-month follow-up
measure: The experience of service questionnaire
timeFrame: Assessed at 6-month follow-up
Secondary outcomes:
measure: Acceptance and Action Questionnaire II
timeFrame: Assessed at 3, 6 and 12-month follow-up.
measure: Avoidance and Fusion Questionnaire for Youth 8-items
timeFrame: Assessed at 3, 6 and 12-month follow-up.
measure: World Health Organisation wellbeing index 5-items
timeFrame: Assessed at 3, 6 and 12-month follow-up.
measure: Generalised Anxiety Disorder assessment 7-items
timeFrame: Assessed at 3, 6 and 12-month follow-up.
measure: Patient Health Questionnaire 9-items
timeFrame: Assessed at 3, 6 and 12-month follow-up.
measure: Client Service Receipt Inventory
timeFrame: Assessed at 3, 6 and 12-month follow-up.
measure: TAND - TSC Associated Neuropsychiatric Disorders
timeFrame: Assessed at 3, 6 and 12-month follow-up.
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Assessed at 3, 6 and 12-month follow-up.
measure: Experiential interviews
timeFrame: Assessed at 3- and 6-month follow-up
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston NHS Trust
Study officials:
affiliation: University Hospitals Bristol & Weston NHS Trust
name: Sam Amin, MBCHB MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: