Feasibility of Group-based Acceptance and Commitment Therapy for Adolescents (AHEAD) With Functional Somatic Syndromes: A Pilot Study

University of Aarhus0 sites21 target enrollmentMay 29, 2013

ConditionsFunctional Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Functional Disorder
Sponsor: University of Aarhus
Enrollment: 21
Primary Endpoint: Change in Short Form Health Survey-36 (SF36) (Assessment of an aggregate score measuring physical health)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

May 29, 2013

End Date

April 24, 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

Time Frame: 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)

Questionnaire, patient rated. Physical health measured with aggregate scores of the scales PF (physical functioning), BP (bodily pain) and VT (vitality). Score range 15-65. Higher scores indicating a higher degree of self-rated physical health.

Secondary Outcomes

Change in Limitation index Questionnaire(At baseline (i.e. at clinical assessment), before psychiatric consultation (approximately 2 weeks after clinical assessment), and at 2, 3, 4, 5, and 8 months (corresponding to before therapy, after 4th, 8th, 9th module and at follow up meeting))
Change in Whiteley 7(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))
Change in SF-36 PCS(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))
Change in Bodily Distress Syndrome checklist (BDS checklist)(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))
Change in AFQ-Y8 (Avoidance and Fusion Questionnaire in Youth)(At baseline (i.e. at clinical assessment) and at 2, 3, 4, 5, and 8 months (corresponding to before therapy, after 4th, 8th, 9th module and at follow up meeting))
Change in SCL-8 Questionnaire(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))
Change in SF-36 MCS(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))
Change in IPQ-R Illness Perceptions Questionnaire(At baseline (i.e. at clinical assessment) and at 2, 3, 4, 5, and 8 months (corresponding to before therapy, after 4th, 8th, 9th module and at follow up meeting))
Change in BRIQ Behavioural Responses to Illness Questionnaire(At baseline (i.e. at clinical assessment) and at 2, 3, 4, 5, and 8 months (corresponding to before therapy, after 4th, 8th, 9th module and at follow up meeting))
PGIC (Patient Global Impression of Change)(At 8 months corresponding to at follow up meeting)