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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04464447
Other study ID # AHEAD pilot
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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