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

Not Applicable

Completed

• Conditions: Functional Disorder
• Interventions: Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT04464447
• Lead Sponsor: University of Aarhus

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-05-29
• Primary Completion: 2015-04-15
• Study Completion: 2015-04-24
• Status Verified: 2020-06
• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Short Form Health Survey-36 (SF36) (Assessment of an aggregate score measuring 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)	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 Outcome Measures

Name	Time	Method
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)	Aggregate score from questionnaire - physical component summary. Patient rated. The aggregate score has a mean of 50 and a SD of 10, but no range. Higher scores indicate better physical health.
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)	Questionnaire, patient rated. Assessment of symptom interference. Score range 0-36 with higher score indicating a higher degree of limitation.
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)	Questionnaire, patient rated. Assessment of illness worry. Overall mean item score range from 0-4 with higher scores indicating a higher degree of illness worry.
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)	Questionnaire, patient rated. Assessment of symptom severity. Score range 0-100. Higher score indicating a higher degree of symptom severity.
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)	Questionnaire, patient rated. Assessment of psychological flexibility. Treatment target. Score range 0-32 with higher scores relfecting a higher degree of psychological inflexibility.
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)	Questionnaire, patient rated. Assessment of emotional distress. Overall mean score range from 0-4 with higher scores indicating a higher degree of emotional distress.
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)	Aggregate score from questionnaire - mental component summary. Patient rated. The aggregate score has a mean of 50 and a SD of 10, but no range. Higher scores indicate better mental health.
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)	Questionnaire, patient rated. Treatment target. Score range 0-80 with higher scores reflecting a more maladaptive view of the illness.
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)	Questionnaire, patient rated. Assessment of illness related behaviour. Treatment target. Measures two dimensions of illness behaviour i.e. limiting behaviour (score range 7-35) and all-or-nothing behaviour (score range 6-30). Higher scores indicate a higher degree of maladaptive behaviour.
PGIC (Patient Global Impression of Change)	At 8 months corresponding to at follow up meeting	Questionnaire, patient rated. 7 point scale with answers ranging from "no change or condition gotten worse" to "a great deal better and a considerable improvement that has made all the difference".