Clinical trial NCT04464447: Feasibility and Pilot Testing of Group-based ACT for Adolescents With Functional Somatic Syndromes
Official title: Feasibility of Group-based Acceptance and Commitment Therapy for Adolescents (AHEAD) With Functional Somatic Syndromes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Disorder
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2020-07-09
Enrollment: 21
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Short Form Health Survey-36 (SF36) (Assessment of an aggregate score measuring physical health)
timeFrame: 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 outcomes:
measure: Change in Bodily Distress Syndrome checklist (BDS checklist)
timeFrame: 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)
measure: Change in Limitation index Questionnaire
timeFrame: 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)
measure: Change in Whiteley 7
timeFrame: 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)
measure: Change in SCL-8 Questionnaire
timeFrame: 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)
measure: Change in SF-36 PCS
timeFrame: 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)
measure: Change in SF-36 MCS
timeFrame: 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)
measure: Change in IPQ-R Illness Perceptions Questionnaire
timeFrame: 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)
measure: Change in BRIQ Behavioural Responses to Illness Questionnaire
timeFrame: 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)
measure: Change in AFQ-Y8 (Avoidance and Fusion Questionnaire in Youth)
timeFrame: 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)
measure: PGIC (Patient Global Impression of Change)
timeFrame: At 8 months corresponding to at follow up meeting
Other outcomes:
measure: Modified version of ESQ Experience of Service Questionnaire
timeFrame: At 8 months corresponding to at follow up meeting
measure: Questions concerning close relatives' satisfaction with information meeting
timeFrame: At meeting for close relatives corresponding to approximately 1 week after start of group therapy (i.e. at 2 months)
Locations:
Study officials:
affiliation: Aarhus University and during study the Research Clinic for Functional Disorders and Psychosomatics
name: Charlotte U Rask, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kallesoe KH, Schroder A, Wicksell RK, Preuss T, Jensen JS, Rask CU. Feasibility of group-based acceptance and commitment therapy for adolescents (AHEAD) with multiple functional somatic syndromes: a pilot study. BMC Psychiatry. 2020 Sep 21;20(1):457. doi: 10.1186/s12888-020-02862-z.