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

NCT04464447 | Completed

• 1 other identifier: AHEAD pilot
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Functional Disorder

Outcome Measures

Primary Outcomes (1)

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

  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.

  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)

Secondary Outcomes (10)

• 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 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 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 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)

Other Outcomes (2)

• Modified version of ESQ Experience of Service Questionnaire

  At 8 months corresponding to at follow up meeting

• Questions concerning close relatives' satisfaction with information meeting

  At meeting for close relatives corresponding to approximately 1 week after start of group therapy (i.e. at 2 months)

Study Arms (1)

Group-based Acceptance and Commitment Therapy

OTHER

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

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy 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.

Group-based Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 32957944 DERIVED

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Charlotte U Rask, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 9, 2020
• Study Start: May 29, 2013
• Primary Completion: April 15, 2015
• Study Completion: April 24, 2015
• Last Updated: June 14, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share