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
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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