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Somatization DisorderNCT02346071

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

A study testing Acceptance and Commitment Therapy in people with Somatization Disorder and Somatoform Disorders, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 19 years
Conditions the study is for
Somatization Disorder, Somatoform Disorders
What is being tested?
Acceptance and Commitment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteDenmark
Study dates
30 Jan 2015to 21 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Severe Bodily Distress Syndrome (multi-organ type) of at least 12 months duration.
  • 15-19 year-old.
  • Born in Denmark or by Danish parents. Understand, speak and read Danish.

Who cannot join

  • 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.
  • Pregnancy at the time of inclusion.
  • 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).

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Research Clinic for Functional Disorders and Psychosomatics

    Aarhus, 8200

Other trials in Denmark

About this study

Official title: Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes: Randomized Trial

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.

Read more

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.

Read the detailed description

Background:

An increasing number of adolescents report daily physical symptoms, with a current prevalence of 25%. A substantial proportion of these young people is examined in the health care system, most often with the conclusion that their symptoms cannot be explained in terms of a well-defined medical disease and are hence "stress-related" or "functional". Typically, the symptoms remit spontaneously after the patient is reassured. However, approximately 5-10% experience persistent symptoms and reduced functioning. They may receive diagnoses for functional somatic syndromes (FSS) such as chronic fatigue syndrome (CFS), fibromyalgia (FM), recurrent abdominal pain/irritable bowel syndrome (IBS) or idiopathic pain syndrome. These adolescents are at risk of social isolation, long term school-absence and reduced quality of life.

The aetiology of FSS is assumed complex, with interacting biological, psychological and environmental factors. Recent studies suggest that dysfunction of the stress-axes (e.g. the hypothalamic-pituitary-adrenal (HPA) axis and the autonomic nervous system) and activated inflammatory response are likely to play a role in the development and perpetuation of the symptoms in various FSS. Besides common pathophysiological mechanisms, FSS also show similarities in patient characteristics and treatment response, which speaks in favour of a common family of disorders. Recently, the unifying diagnostic category Bodily Distress Syndrome (BDS) was introduced. BDS is conceptualized as a (patho)physiologic response to prolonged or severe mental and/or physical stress in genetically susceptible individuals, and the diagnosis has been shown to encompass the majority of FSS.

FSS in adults can be managed effectively be means of psychological treatment, but the evidence for adolescents with severe FSS is sparse. Family based cognitive behavioural therapy (CBT) and internet-delivered CBT has proven effective for young patients with particular symptom profiles. However, the development of various specific treatments for each FSS or symptom profile is not an efficient strategy. Recent studies suggest that adult patients with various FSS sampled by the BDS diagnosis can feasibly be treated together, regardless of their main somatic complaint. The same may be true for adolescents, and hence the development of a common treatment for adolescents with various FSS or BDS may be advantageous, and facilitate further implementation in routine clinical care if the treatment is found effective.

Acceptance and Commitment Therapy (ACT), which derives from CBT, has shown promising results in children with chronic functional pain. Improvement could be demonstrated by less avoidance of important activities, better emotional wellbeing and less health care utilization. The aim of this project is to develop an ACT-based group intervention for adolescents with a range of FSS, i.e. conceptualised as severe BDS, and to evaluate its efficacy in a randomized controlled trial.

Method:

Patient population: 120 adolescents with BDS referred to The Research Clinic for Functional Disorders and Psychosomatics (FFL), Aarhus University Hospital. Patients are referred from general practitioners, specialists and hospital wards.

Diagnostic assessment: BDS will be diagnosed after a diagnostic work-up by a physician based on: 1) a review of former medical discharge letters, medical records and other relevant information, 2) SCAN (Schedules for Clinical Assessment in Neuropsychiatry) which screens for general psychopathology and contains a detailed section on BDS 3) screening for ADHD, autism and conduct disorder with screening questions from the child and adolescent psychiatric interview DAWBA (Development and Well Being Assessment), 4) a physical/neurological examination and 5) standard blood tests.

Procedure: Eligible patients, meeting all study criteria, are asked to participate in the RCT. The outcome measures will be filled in at baseline (T0), (i.e. at clinical assessment), before start of therapy (T1), (i.e. two months after baseline), after 8 sessions of therapy (T2), (i.e. 4 months after baseline), two weeks after 9 sessions of therapy (end of treatment, T3) (i.e. 5½ months after baseline) and at eight (T4) and twelve months (T5) after baseline. A physiological assessment of stress response and inflammatory response will be performed at T0 and T5.

Hypotheses:

Primary hypothesis: Patients randomized to ACT-based group therapy will report statistically and clinically significant better self-reported physical health twelve months after baseline, compared to patients receiving a standard psychiatric consultation only (SPC).

Secondary hypotheses: Compared to the control group (SPC), patients receiving ACT-group therapy will at eight and twelve months after baseline: 1. Report statistically and clinically significant reductions in somatic symptoms. 2. Report statistically and clinically significant lower symptom interference and at twelve months after baseline: 3. Show significant improvement in alterations of stress response and inflammatory response. The patients receiving ACT-group therapy will show good feasibility regarding treatment.

Being tested
Acceptance and Commitment Therapy, Enhanced Usual Care (EUC)
Keywords
Bodily distress syndrome, Medically unexplained symptoms, Functional somatic symptoms, Functional somatic syndromes, Treatment, Acceptance and Commitment Therapy
Medical subject headings
Somatoform Disorders, Medically Unexplained Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment TherapyBehavioural

    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.

  • 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.

Study groups in NCT02346071
Study groupRoleWhat they receive
Enhanced Usual Care (EUC)Active comparatorClinical psychiatric and somatic assessment. Standard psychiatric consultation (SPC) given 2 weeks after randomization.
Receives: Other: Enhanced Usual Care (EUC)
Acceptance and Commitment Therapy (ACT)ExperimentalClinical psychiatric and somatic assessment. Standard psychiatric consultation (SPC) given 2 weeks after randomization. ACT-based group therapy.
Receives: Behavioral: Acceptance and Commitment Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (11)
  1. Change in BDS checklist (Assessment of symptom severity)

    Questionnaire, patient rated. Assessment of symptom severity.

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

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

    Questionnaire, patient rated. Assessment of functional symptoms.

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

  3. Change in Limitation index Questionnaire (Assessment of symptom interference)

    Questionnaire, patient and parent rated. Assessment of symptom interference.

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

  4. PGIC (Patient Global Impression of Change)

    Questionnaire, patient and parent rated.

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

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

    Questionnaire. Patient rated. Assessment of health related quality of life using Social Functioning Scale and Mental Health Scale.

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

  6. Change in SCL-8, SCL-6, SCL-4 Questionnaire (Assessment of depression and anxiety)

    Questionnaire, patient rated. Assessment of depression and anxiety.

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

  7. Change in HRV heart rate variability (assessment of stress response in various situations (resting state, standing, slow breathing and valsalva)

    Physiological assessment of stress response in various situations (resting state, standing, slow breathing and valsalva).

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

  8. Change in hair cortisol (Measurement of the level of stress-hormone cortisol in hair)

    Measurement of the level of stress-hormone cortisol in hair.

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

  9. Change in level of inflammatory and oxidative stress

    Biomarkers for inflammatory and oxidative stress (e.g. IL1, IL6, TNF-alpha, high-sensitive CRP, neopterin, CD163, HO1, MCP1 but also newer proteo-based markers).

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

  10. Level of physical activity (Anthropometric measurements with accelerometer (Actigraph GT3X)

    Anthropometric measurements with accelerometer (Actigraph GT3X), duration 1 week (24h/day).

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

  11. Change in PSS (Perceived Stress Scale)

    Questionnaire, patient rated. Assessment of self perceived stress level.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2015 (estimated)
  2. Study start30 Jan 2015
  3. Primary completion13 Nov 2019
  4. Study completion21 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02346071
Sponsor's protocol ID
CURKHK1
Status last verified
Nov 2019
First submitted
2 Dec 2014
Last updated
25 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38317120
  • 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.

    PubMed 37431406
  • 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.

    PubMed 27633643

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy in people with Somatization Disorder and Somatoform Disorders, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in SF36 (Assessment of physical health) (time frame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02346071, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.

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