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

June 9, 2021 updated by: University of Aarhus

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 15 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group-based Acceptance and Commitment Therapy
Group-based Acceptance and Commitment Therapy (ACT) for adolescents presenting with multiple functional somatic syndromes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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".
At 8 months corresponding to at follow up meeting

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At 8 months corresponding to at follow up meeting
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.
At meeting for close relatives corresponding to approximately 1 week after start of group therapy (i.e. at 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charlotte U Rask, MD, PhD, Aarhus University and during study the Research Clinic for Functional Disorders and Psychosomatics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AHEAD pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Has not been incorporated in the consent from the patients. However, some data will be available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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