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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04464447
Acronym
AHEAD
Enrollment
21
Registered
2020-07-09
Start date
2013-05-29
Completion date
2015-04-24
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Disorder

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).

Interventions

BEHAVIORALAcceptance 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.

Sponsors

Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 19 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 Limitation index QuestionnaireAt 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 7At 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 SCL-8 QuestionnaireAt 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 PCSAt 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 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.
PGIC (Patient Global Impression of Change)At 8 months corresponding to at follow up meetingQuestionnaire, 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.
Change in SF-36 MCSAt 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 QuestionnaireAt 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 QuestionnaireAt 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.

Other

MeasureTime frameDescription
Modified version of ESQ Experience of Service QuestionnaireAt 8 months corresponding to at follow up meetingQuestionnaire, patient rated. Assessment of their treatment experience.
Questions concerning close relatives' satisfaction with information meetingAt meeting for close relatives corresponding to approximately 1 week after start of group therapy (i.e. at 2 months)Questions regarding specific meeting content and possibility of free text comments. Rated by close relatives.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026