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

NCT ID: NCT04464447

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-29

Study Completion Date

2015-04-24

Brief Summary

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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).

Detailed Description

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Conditions

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Functional Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group-based Acceptance and Commitment Therapy

Group-based Acceptance and Commitment Therapy (ACT) for adolescents presenting with multiple functional somatic syndromes.

Group Type OTHER

Acceptance and Commitment Therapy

Intervention Type BEHAVIORAL

The treatment "ACT for Health in Adolescents" (AHEAD) is an ACT-based Group intervention consisting of 9 modules (27 hours in total) delivered over a period of 3 months, with a follow-up meeting (3 hours) 3 months after the last module. Six to eight patients participate in each treatment Group. An information meeting (3 hours) for close relatives is held at the beginning of the Group treatment and the adolescents and their parents were invited to a 1½-hour individual consultation after the 8th module.

Interventions

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Acceptance and Commitment Therapy

The treatment "ACT for Health in Adolescents" (AHEAD) is an ACT-based Group intervention consisting of 9 modules (27 hours in total) delivered over a period of 3 months, with a follow-up meeting (3 hours) 3 months after the last module. Six to eight patients participate in each treatment Group. An information meeting (3 hours) for close relatives is held at the beginning of the Group treatment and the adolescents and their parents were invited to a 1½-hour individual consultation after the 8th module.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte U Rask, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University and during study the Research Clinic for Functional Disorders and Psychosomatics

References

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Kallesoe KH, Schroder A, Wicksell RK, Preuss T, Jensen JS, Rask CU. Feasibility of group-based acceptance and commitment therapy for adolescents (AHEAD) with multiple functional somatic syndromes: a pilot study. BMC Psychiatry. 2020 Sep 21;20(1):457. doi: 10.1186/s12888-020-02862-z.

Reference Type DERIVED
PMID: 32957944 (View on PubMed)

Other Identifiers

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AHEAD pilot

Identifier Type: -

Identifier Source: org_study_id

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