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Functional DisorderAHEADNCT04464447

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

A study testing Acceptance and Commitment Therapy in people with Functional Disorder, run by University of Aarhus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 15 to 19 years
Conditions the study is for
Functional Disorder
What is being tested?
Acceptance and Commitment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
No sites listed yet
Study dates
29 May 2013to 24 Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

About this study

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

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).

Being tested
Acceptance and Commitment Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment TherapyBehavioural

    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.

Study groups in NCT04464447
Study groupRoleWhat they receive
Group-based Acceptance and Commitment TherapyOtherGroup-based Acceptance and Commitment Therapy (ACT) for adolescents presenting with multiple functional somatic syndromes.
Receives: Behavioral: Acceptance and Commitment Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 (10)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: 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)

  8. 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.

    Measured: 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)

  9. 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.

    Measured: 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)

  10. 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".

    Measured: At 8 months corresponding to at follow up meeting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start29 May 2013
  3. Primary completion15 Apr 2015
  4. Study completion24 Apr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464447
Sponsor's protocol ID
AHEAD pilot
Acronym
AHEAD
Status last verified
Jun 2020
First submitted
27 Jun 2020
Last updated
14 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Has not been incorporated in the consent from the patients. However, some data will be available upon request.

Publications

  • 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.

    PubMed 32957944

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy in people with Functional Disorder, run by University of Aarhus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04464447, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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