Acceptance and Commitment Therapy in Tuberous Sclerosis Complex

NCT05867576 | Active Not Recruiting

• 1 other identifier: CH/2020/7042
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberous Sclerosis Complex

Keywords

Tuberous Sclerosis Complex; Acceptance and Commitment Therapy; Mental Health; Psychology; Paediatrics; Neurology; Remote therapy; TAND

Outcome Measures

Primary Outcomes (8)

• Treatment completion rate

  The proportion of patients showing interest who then consent to the trial and complete the intervention.

  Assessed at 3-month follow-up.

• Treatment completion rate

  The proportion of patients showing interest who then consent to the trial and complete the intervention.

  Assessed at 6-month follow-up

• Session attendance rate

  The session attendance rate compared to feasibility benchmarks.

  Assessed at 3-month follow-up

• Session attendance rate

  The session attendance rate compared to feasibility benchmarks.

  Assessed at 6-month follow-up

• The credibility/expectancy questionnaire

  Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.

  Assessed at baseline

• The credibility/expectancy questionnaire

  Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.

  Assessed at session 2

• The experience of service questionnaire

  A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.

  Assessed at 3-month follow-up

• The experience of service questionnaire

  A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.

  Assessed at 6-month follow-up

Secondary Outcomes (9)

• Acceptance and Action Questionnaire II

  Assessed at 3, 6 and 12-month follow-up.

• Avoidance and Fusion Questionnaire for Youth 8-items

  Assessed at 3, 6 and 12-month follow-up.

• World Health Organisation wellbeing index 5-items

  Assessed at 3, 6 and 12-month follow-up.

• Generalised Anxiety Disorder assessment 7-items

  Assessed at 3, 6 and 12-month follow-up.

• Patient Health Questionnaire 9-items

  Assessed at 3, 6 and 12-month follow-up.

Study Arms (2)

Allocated to treatment

ACTIVE COMPARATOR

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.

Behavioral: Acceptance and Commitment Therapy (ACT)

Allocated to waitlist control

NO INTERVENTION

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

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

Allocated to treatment

Eligibility Criteria

• Age: 11 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead
• The Tuberous Sclerosis Association: collaborator
• University College, London: collaborator

Study Sites (1)

University Hospitals Bristol and Weston NHS Trust

Bristol, United Kingdom

Location

MeSH Terms

Conditions

Tuberous Sclerosis; Psychological Well-Being

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sam Amin, MBCHB MSc PhD

  University Hospitals Bristol & Weston NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study design is an unblinded, waitlist-controlled, randomised controlled trial (RCT). Randomisation will be conducted using established randomisation software RedCap. Researchers will not be blind to trial arm allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 22, 2023
• Study Start: August 12, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)