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

NCT02346071 | Completed

• 1 other identifier: CURKHK1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Examine the efficacy of group based ACT in adolescents (aged 15-19 years) with severe FSS.

Conditions

Somatization Disorder; Somatoform Disorders

Keywords

Bodily distress syndrome; Medically unexplained symptoms; Functional somatic symptoms; Functional somatic syndromes; Treatment; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• Change in SF36 (Assessment of physical health)

  Questionnaire, patient rated. Physical health measured with aggregate scores of the scales PF (physical functioning), BP (bodily pain) and VT (vitality).

  At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.

Secondary Outcomes (11)

• Change in BDS checklist (Assessment of symptom severity)

  At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).

• Change in SCL-somatization Questionnaire (Assessment of functional symptoms)

  At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.

• Change in Limitation index Questionnaire (Assessment of symptom interference)

  At baseline (i.e. at clinical assessment) and 5½, 8 and 12 months after baseline (primary endpoint).

• PGIC (Patient Global Impression of Change)

  At 5½, 8 and 12 (primary endpoint) months after baseline.

• Change in SF36 Questionnaire (Assessment of health related quality of life)

  At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.

Other Outcomes (12)

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

  At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.

• Change in IPQ-R Illness Perceptions Questionnaire

  At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.

• Change in BRIQ Behavioural Responses to Illness Questionnaire

  At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.

Study Arms (2)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Clinical psychiatric and somatic assessment. Standard psychiatric consultation (SPC) given 2 weeks after randomization.

Other: Enhanced Usual Care (EUC)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Clinical psychiatric and somatic assessment. Standard psychiatric consultation (SPC) given 2 weeks after randomization. ACT-based group therapy.

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Acceptance and Commitment Therapy (ACT)

Enhanced Usual Care (EUC) OTHER

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.

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Severe Bodily Distress Syndrome (multi-organ type) of at least 12 months duration.
• year-old.
• Born in Denmark or by Danish parents. Understand, speak and read Danish.

You may not qualify if:

• No informed consent.
• An 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).
• Abuse of narcotics, alcohol or medicine.
• Not fit for 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).

Sponsors & Collaborators

• University of Aarhus: lead
• Karolinska University Hospital: collaborator
• National Research Centre for the Working Environment, Denmark: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Research Clinic for Functional Disorders and Psychosomatics

Aarhus, 8200, Denmark

Location

Related Publications (3)

• Nyengaard R, Kallesoe KH, Rimvall MK, Ornbol E, Wellnitz KB, Olsen EM, Wyller VBB, Rask CU. Hair cortisol and self-perceived stress in adolescents with multi-system functional somatic disorders. BMC Psychiatry. 2024 Feb 5;24(1):101. doi: 10.1186/s12888-024-05518-4.

  PMID: 38317120 DERIVED

• Kallesoe KH, Schroder A, Jensen JS, Wicksell RK, Rask CU. Group-based Acceptance and Commitment Therapy (AHEAD) for adolescents with multiple functional somatic syndromes: A randomised trial. JCPP Adv. 2021 Dec 8;1(4):e12047. doi: 10.1002/jcv2.12047. eCollection 2021 Dec.

  PMID: 37431406 DERIVED

• Kallesoe KH, Schroder A, Wicksell RK, Fink P, Ornbol E, Rask CU. Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial. BMJ Open. 2016 Sep 15;6(9):e012743. doi: 10.1136/bmjopen-2016-012743.

  PMID: 27633643 DERIVED

Related Links

• Homepage for the Research Clinic for Functional Disorders, Aarhus University Hospital

MeSH Terms

Conditions

Somatoform Disorders; Medically Unexplained Symptoms

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Charlotte U Rask, MD, PhD

  Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: January 26, 2015
• Study Start: January 30, 2015
• Primary Completion: November 13, 2019
• Study Completion: November 21, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

DK (1)