CompletedNot Applicable

Feasibility and Pilot Testing of Group-based ACT for Adolescents With Functional Somatic Syndromes

21 participantsStarted 2013-05-29

Plain-language summary

Recurrent and impairing functional somatic syndromes (FSS) are common in adolescents. Despite a high need for care, empirically supported treatments are lacking for youth. The aim of the uncontrolled was to assess feasibility and treatment potential of group-based Acceptance and Commitment Therapy (ACT) in a generic treatment approach for adolescents with multiple FSS i.e. "ACT for Health in Adolescents" (AHEAD).

Who can participate

Age range

15 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Bodily Distress Syndrome, multi-organ type of at least 12 months' duration * Raised since early childhood in Denmark or born by Danish parents * Understand, speak and read Danish * Moderate or severe impairment Exclusion Criteria: * Acute psychiatric disorder demanding other treatment, or if the patient is suicidal. * A lifetime diagnosis of psychosis, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.2, F33.3), serious cognitive deficits or developmental disorders such as mental retardation and autism (ICD-10: F70, F84) * Substance abuse of e.g. narcotics, alcohol or medication. * Pregnancy at time of inclusion * Not able to participate in group-based treatment, e.g. patients with severe ADHD (ICD-10: F90), severe social phobia (ICD-10: F40.1) or conduct disorder (ICD-10: F91)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Short Form Health Survey-36 (SF36) (Assessment of an aggregate score measuring physical health)

Timeframe: At baseline (i.e. at clinical assessment), and at 2, 4, 5, and 8 months (corresponding to group start, 8th, 9th module and follow up meeting)

Trial details

NCT IDNCT04464447

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04-15

View on ClinicalTrials.gov More Functional Disorder trials