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

Functional Disorder Clinical Trial

— AHEAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464447
• Other study ID #: AHEAD pilot
• Status: Completed
• Phase: N/A
• Start date: May 29, 2013
• Est. completion date: April 24, 2015

Study information

• Verified date: June 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 24, 2015
• Est. primary completion date: April 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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)

Related Conditions & MeSH terms

• Functional Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified version of ESQ Experience of Service Questionnaire	Questionnaire, patient rated. Assessment of their treatment experience.	At 8 months corresponding to at follow up meeting
Other	Questions concerning close relatives' satisfaction with information meeting	Questions regarding specific meeting content and possibility of free text comments. Rated by close relatives.	At meeting for close relatives corresponding to approximately 1 week after start of group therapy (i.e. at 2 months)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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