NCT02346071

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

Completed NA Last updated 25 November 2019

What this trial tests

NA trial testing Acceptance and Commitment Therapy in Somatization Disorder in 91 participants. Completed in 21 November 2019.

Timeline

30 January 2015

Primary endpoint
13 November 2019

21 November 2019

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	91
Start date	30 January 2015
Primary completion	13 November 2019
Estimated completion	21 November 2019
Sites	1 location across Denmark

Drugs / interventions tested

• Acceptance and Commitment Therapy
• Enhanced Usual Care (EUC)

Conditions studied

• Somatization Disorder — all drugs for Somatization Disorder →
• Somatoform Disorders — all drugs for Somatoform Disorders →

Sponsor

University of Aarhus

Who can join

Adults 15 to 19, any sex, with Somatization Disorder or Somatoform Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Group-based Acceptance and Commitment Therapy (AHEAD) for adolescents with multiple functional somatic syndromes: A randomised trial.
   Kallesøe KH, Schröder A, Jensen JS, Wicksell RK, et al · · 2021 · cited 12× · PMID 37431406 · DOI 10.1002/jcv2.12047
2. 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.
   Kallesøe KH, Schröder A, Wicksell RK, Fink P, et al · · 2016 · cited 8× · PMID 27633643 · DOI 10.1136/bmjopen-2016-012743
3. Clinical Impact of Systematic Assessment and Psychoeducation in Specialized Treatment of Adolescents with Severe Functional Somatic Disorders: Results from the AHEAD Study.
   Kallesøe KH, Wellnitz KB, Ørnbøl E, Rask CU. · · 2023 · cited 2× · PMID 37508598 · DOI 10.3390/children10071101
4. Hair cortisol and self-perceived stress in adolescents with multi-system functional somatic disorders.
   Nyengaard R, Kallesøe KH, Rimvall MK, Ørnbøl E, et al · · 2024 · cited 1× · PMID 38317120 · DOI 10.1186/s12888-024-05518-4