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Completed

NCT Number: NCT04464447

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

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).

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Key information

Conditions

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

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.

Primary outcomes

  1. Change in Short Form Health Survey-36 (SF36) (Assessment of an aggregate score measuring physical health)

    Time frame: 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 outcomes

  1. Change in Bodily Distress Syndrome checklist (BDS checklist)

    Time frame: 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.

  2. Change in Limitation index Questionnaire

    Time frame: 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)

    Questionnaire, patient rated. Assessment of symptom interference. Score range 0-36 with higher score indicating a higher degree of limitation.

  3. Change in Whiteley 7

    Time frame: 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 illness worry. Overall mean item score range from 0-4 with higher scores indicating a higher degree of illness worry.

  4. Change in SCL-8 Questionnaire

    Time frame: 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 emotional distress. Overall mean score range from 0-4 with higher scores indicating a higher degree of emotional distress.

  5. Change in SF-36 PCS

    Time frame: 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)

    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.

  6. Change in SF-36 MCS

    Time frame: 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)

    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.

  7. Change in IPQ-R Illness Perceptions Questionnaire

    Time frame: 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. Treatment target. Score range 0-80 with higher scores reflecting a more maladaptive view of the illness.

  8. Change in BRIQ Behavioural Responses to Illness Questionnaire

    Time frame: 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 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.

  9. Change in AFQ-Y8 (Avoidance and Fusion Questionnaire in Youth)

    Time frame: 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.

  10. PGIC (Patient Global Impression of Change)

    Time frame: At 8 months corresponding to at follow up meeting

    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".

Other outcomes

  1. Modified version of ESQ Experience of Service Questionnaire

    Time frame: At 8 months corresponding to at follow up meeting

    Questionnaire, patient rated. Assessment of their treatment experience.

  2. Questions concerning close relatives' satisfaction with information meeting

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: AHEAD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2020
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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