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

Study Overview
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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).

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

Conditions
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Functional Disorder

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group-based Acceptance and Commitment Therapy<br>Group-based Acceptance and Commitment Therapy (ACT) for adolescents presenting with multiple functional somatic syndromes. | Behavioral: Acceptance and Commitment Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bodily Distress Syndrome checklist (BDS checklist) | Questionnaire, patient rated. Assessment of symptom severity. Score range 0-100. Higher score indicating a higher degree of symptom severity. | 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 | Questionnaire, patient rated. Assessment of symptom interference. Score range 0-36 with higher score indicating a higher degree of limitation. | 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 | 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. | 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 | Questionnaire, patient rated. Assessment of emotional distress. Overall mean score range from 0-4 with higher scores indicating a higher degree of emotional distress. | 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 | 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. | 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 | 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. | 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 | Questionnaire, patient rated. Treatment target. Score range 0-80 with higher scores reflecting a more maladaptive view of the illness. | 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 | 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. | 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 AFQ-Y8 (Avoidance and Fusion Questionnaire in Youth) | Questionnaire, patient rated. Assessment of psychological flexibility. Treatment target. Score range 0-32 with higher scores relfecting a higher degree of psychological inflexibility. | 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) | 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. | At 8 months corresponding to at follow up meeting |