Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes

NCT02346071 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2019-11-25

No results posted yet for this study

Summary

Background:

An increasing number of adolescents report recurrent functional somatic symptoms. Some experience persistent symptoms and may receive functional somatic syndromes (FSS) diagnoses (i.e. symptoms not attributable to any known conventionally defined physical disease), characterised by severe disability and reduced quality of life.

The aim of this study is to:

1. Develop an Acceptance and Commitment Therapy (ACT)-based group intervention for adolescents with severe FSS (conceptualized as Bodily Distress Syndrome (BDS), see detailed description).
2. Examine the efficacy of group based ACT in adolescents (aged 15-19 years) with severe FSS.

The ACT-based treatment, with 9 sessions of group therapy and one follow up meeting is compared to standard treatment/enhanced usual care, which is one single advisory consultation.

The study includes approximately 120 patients.

Conditions

  • Somatization Disorder
  • Somatoform Disorders

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy

All patients will have a thorough clinical psychiatric and somatic assessment in order to determine eligibility and a psychiatric consultation (SPC) of 1-1½ hrs. duration approx. 2 weeks after randomization. The ACT treatment is manualized and given in groups of 7-8 patients with 9 3-hour sessions (i.e. 27 hours in total) over a period of 3 months and one follow up meeting (3 hours) three months after end of treatment. The parents and other relevant close relatives (e.g. siblings, boy/girlfriends) to the patient participate in a workshop where ACT principles are applied. One individual consultation with the adolescent and parents will be offered at the end of 8 sessions of group therapy.

OTHER

Enhanced Usual Care (EUC)

All patients will have a thorough clinical psychiatric and somatic assessment in order to determine eligibility and a psychiatric consultation (SPC) of 1-1½ hrs. duration approx. 2 weeks after randomization. The consultation is according to a manual and includes psycho-education related to the diagnosis of multiorgan BDS, health promoting recommendations and counselling regarding existing medicine or other treatment. An individualized treatment plan will be sent to the patient's general practitioner, to optimize management in primary care and support by social services.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER
  • National Research Centre for the Working Environment, Denmark

    collaborator OTHER_GOV
  • Aarhus University Hospital

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Charlotte U Rask, MD, PhD · Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-30
Primary Completion
2019-11-13
Completion
2019-11-21

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02346071 on ClinicalTrials.gov