Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||11 Years - 24 Years|
- - Aged 11-to-24 years at the time of randomisation.
- - Received treatment for a brain tumour at a participating Principle Treatment Centre.
- - Active brain tumour treatment is complete and their condition stable for at least six-months.
- - Have sufficient cognitive ability to engage with ACT sessions as judged by the clinician at baseline assessment.
- - competent to provide informed consent (participants aged 16 or over) or assent
(participants aged 11-15)
- Parent/carer competent to provide informed consent (for participants aged 11-15)
Exclusion Criteria:- Received a structured behavioural intervention within six-months prior to study recruitment.
- - Previous or current alcohol/substance dependence, psychosis, suicidality, or eating disorder.
- - Moderate or severe intellectual disability, confirmed through researcher judgement at screening through questions relating to school type and previous diagnoses.
- - Immediate risk to self or others.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Nottingham University Hospitals NHS Trust|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Sophie Thomas, DClinPsy|
|Principal Investigator Affiliation||Nottingham University Hospitals NHS Trust|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Brain Tumors, Quality of Life, Brain Tumor, Pediatric|
Experimental: Immediate Acceptance and Commitment Therapy
Receiving 6-to-12 weekly sessions of Acceptance and Commitment Therapy immediately after allocation. Each session will be up to one hour in length.
No Intervention: Waitlist Control
Receiving no intervention during a 12-week wait, though no restrictions will be placed on the use of other services. After the wait participants will receive 6-to-12 weekly sessions of Acceptance and Commitment Therapy. Each session will be up to one hour in length.
Behavioral: - Acceptance and Commitment Therapy
Acceptance and Commitment Therapy (ACT) is an evidence-based psychological therapy that has been used to improve physical and mental health among adults with health conditions, including cancer (Graham, Gouick, Krahe, & Gillanders, 2016). It 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 problems.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.