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Acceptance and Commitment Therapy in Tuberous Sclerosis Complex (ACT in TSC)

Primary Purpose

Tuberous Sclerosis Complex

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT)
Sponsored by
University Hospitals Bristol and Weston NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberous Sclerosis Complex focused on measuring Tuberous Sclerosis Complex, Acceptance and Commitment Therapy, Mental Health, Psychology, Paediatrics, Neurology, Remote therapy, TAND

Eligibility Criteria

11 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Bristol and Weston NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Allocated to treatment

Allocated to waitlist control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Treatment completion rate
The proportion of patients showing interest who then consent to the trial and complete the intervention.
Treatment completion rate
The proportion of patients showing interest who then consent to the trial and complete the intervention.
Session attendance rate
The session attendance rate compared to feasibility benchmarks.
Session attendance rate
The session attendance rate compared to feasibility benchmarks.
The credibility/expectancy questionnaire
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
The credibility/expectancy questionnaire
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
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.
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.

Secondary Outcome Measures

Acceptance and Action Questionnaire II
A brief 7-item self-report measure assessing psychological inflexibility, which is the central treatment target for ACT. Validated for use among patients aged 16 and over. Minimum score = 7; maximum score = 49. Higher scores indicate worse outcome.
Avoidance and Fusion Questionnaire for Youth 8-items
A brief self-report measure of psychological inflexibility, for children (11 to 15 year old participants). Minimum score = 0; maximum score = 32. Higher scores indicate worse outcome.
World Health Organisation wellbeing index 5-items
A brief self-reported assessment of wellbeing and mental health. Minimum score = 7 score; maximum = 49. Higher scores indicate worse outcome. Minimum score = 0; maximum score = 49. Higher scores indicate worse outcome.
Generalised Anxiety Disorder assessment 7-items
A brief self-reported measure of generalised anxiety symptoms using 4-point Likert scales based on diagnostic criteria. Minimum score = 0; maximum score = 21. Higher scores indicate worse outcome.
Patient Health Questionnaire 9-items
Assesses symptoms of depression using self-reported 4-point Likert scales based on diagnostic criteria for major depression. Minimum score = 0; maximum score = 27. Higher scores indicate worse outcome.
Client Service Receipt Inventory
A research instrument developed to collect information on service receipt, service-related issues and income. In addition, the Client Service Receipt Inventory collects information on school attendance in the 3-months prior to assessment.
TAND - TSC Associated Neuropsychiatric Disorders
Assesses behavioural, intellectual, learning and psychiatric impact of TSC.
Pediatric Quality of Life Inventory (PedsQL)
A 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents
Experiential interviews
Participant experiences of treatment as described in semi-structured qualitative interviews

Full Information

First Posted
May 21, 2021
Last Updated
May 10, 2023
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborators
The Tuberous Sclerosis Association, University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT05867576
Brief Title
Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
Acronym
ACT in TSC
Official Title
Randomised Controlled Trial of Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborators
The Tuberous Sclerosis Association, University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberous Sclerosis Complex
Keywords
Tuberous Sclerosis Complex, Acceptance and Commitment Therapy, Mental Health, Psychology, Paediatrics, Neurology, Remote therapy, TAND

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allocated to treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
Allocated to waitlist control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment completion rate
Description
The proportion of patients showing interest who then consent to the trial and complete the intervention.
Time Frame
Assessed at 3-month follow-up.
Title
Treatment completion rate
Description
The proportion of patients showing interest who then consent to the trial and complete the intervention.
Time Frame
Assessed at 6-month follow-up
Title
Session attendance rate
Description
The session attendance rate compared to feasibility benchmarks.
Time Frame
Assessed at 3-month follow-up
Title
Session attendance rate
Description
The session attendance rate compared to feasibility benchmarks.
Time Frame
Assessed at 6-month follow-up
Title
The credibility/expectancy questionnaire
Description
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
Time Frame
Assessed at baseline
Title
The credibility/expectancy questionnaire
Description
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
Time Frame
Assessed at session 2
Title
The experience of service questionnaire
Description
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.
Time Frame
Assessed at 3-month follow-up
Title
The experience of service questionnaire
Description
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.
Time Frame
Assessed at 6-month follow-up
Secondary Outcome Measure Information:
Title
Acceptance and Action Questionnaire II
Description
A brief 7-item self-report measure assessing psychological inflexibility, which is the central treatment target for ACT. Validated for use among patients aged 16 and over. Minimum score = 7; maximum score = 49. Higher scores indicate worse outcome.
Time Frame
Assessed at 3, 6 and 12-month follow-up.
Title
Avoidance and Fusion Questionnaire for Youth 8-items
Description
A brief self-report measure of psychological inflexibility, for children (11 to 15 year old participants). Minimum score = 0; maximum score = 32. Higher scores indicate worse outcome.
Time Frame
Assessed at 3, 6 and 12-month follow-up.
Title
World Health Organisation wellbeing index 5-items
Description
A brief self-reported assessment of wellbeing and mental health. Minimum score = 7 score; maximum = 49. Higher scores indicate worse outcome. Minimum score = 0; maximum score = 49. Higher scores indicate worse outcome.
Time Frame
Assessed at 3, 6 and 12-month follow-up.
Title
Generalised Anxiety Disorder assessment 7-items
Description
A brief self-reported measure of generalised anxiety symptoms using 4-point Likert scales based on diagnostic criteria. Minimum score = 0; maximum score = 21. Higher scores indicate worse outcome.
Time Frame
Assessed at 3, 6 and 12-month follow-up.
Title
Patient Health Questionnaire 9-items
Description
Assesses symptoms of depression using self-reported 4-point Likert scales based on diagnostic criteria for major depression. Minimum score = 0; maximum score = 27. Higher scores indicate worse outcome.
Time Frame
Assessed at 3, 6 and 12-month follow-up.
Title
Client Service Receipt Inventory
Description
A research instrument developed to collect information on service receipt, service-related issues and income. In addition, the Client Service Receipt Inventory collects information on school attendance in the 3-months prior to assessment.
Time Frame
Assessed at 3, 6 and 12-month follow-up.
Title
TAND - TSC Associated Neuropsychiatric Disorders
Description
Assesses behavioural, intellectual, learning and psychiatric impact of TSC.
Time Frame
Assessed at 3, 6 and 12-month follow-up.
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
A 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents
Time Frame
Assessed at 3, 6 and 12-month follow-up.
Title
Experiential interviews
Description
Participant experiences of treatment as described in semi-structured qualitative interviews
Time Frame
Assessed at 3- and 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sam Amin, MBCHB MSc PhD
Phone
0117 3420167
Email
sam.amin@uhbw.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander P Marsh, BSc (Hons). MSc. DClinPsy
Phone
0117 3428306
Email
paediatric.neuropsy@uhbw.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Amin, MBCHB MSc PhD
Organizational Affiliation
University Hospitals Bristol & Weston NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Bristol and Weston NHS Trust
City
Bristol
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Mulligan
Phone
01173429894
Email
R&DSponsorship@uhbw.nhs.uk
First Name & Middle Initial & Last Name & Degree
Sam Amin, MRCPCH MBCHB MSc PhD
First Name & Middle Initial & Last Name & Degree
Jennifer Black, DClinPsy

12. IPD Sharing Statement

Plan to Share IPD
No

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Acceptance and Commitment Therapy in Tuberous Sclerosis Complex

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