Clinical trial NCT02346071: Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes
Official title: Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes: Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatization Disorder
Somatoform Disorders
Keywords: Bodily distress syndrome
Medically unexplained symptoms
Functional somatic symptoms
Functional somatic syndromes
Treatment
Acceptance and Commitment Therapy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: National Research Centre for the Working Environment, Denmark
name: Aarhus University Hospital
First posted: 2015-01-26
Enrollment: 91
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in SF36 (Assessment of physical health)
timeFrame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
Secondary outcomes:
measure: Change in BDS checklist (Assessment of symptom severity)
timeFrame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).
measure: Change in SCL-somatization Questionnaire (Assessment of functional symptoms)
timeFrame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
measure: Change in Limitation index Questionnaire (Assessment of symptom interference)
timeFrame: At baseline (i.e. at clinical assessment) and 5½, 8 and 12 months after baseline (primary endpoint).
measure: PGIC (Patient Global Impression of Change)
timeFrame: At 5½, 8 and 12 (primary endpoint) months after baseline.
measure: Change in SF36 Questionnaire (Assessment of health related quality of life)
timeFrame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
measure: Change in SCL-8, SCL-6, SCL-4 Questionnaire (Assessment of depression and anxiety)
timeFrame: At baseline (i.e. at clinical assessment) and 5½, 8 and 12 (primary endpoint) months after baseline .
measure: Change in HRV heart rate variability (assessment of stress response in various situations (resting state, standing, slow breathing and valsalva)
timeFrame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).
measure: Change in hair cortisol (Measurement of the level of stress-hormone cortisol in hair)
timeFrame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).
measure: Change in level of inflammatory and oxidative stress
timeFrame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).
measure: Level of physical activity (Anthropometric measurements with accelerometer (Actigraph GT3X)
timeFrame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).
measure: Change in PSS (Perceived Stress Scale)
timeFrame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).
Other outcomes:
measure: Change in AFQ-Y8 (Avoidance and Fusion Questionnaire in Youth)
timeFrame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
measure: Change in IPQ-R Illness Perceptions Questionnaire
timeFrame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
measure: Change in BRIQ Behavioural Responses to Illness Questionnaire
timeFrame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
measure: FAD Family Assessment Devise
timeFrame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).
measure: ESQ Experience of Service Questionnaire
timeFrame: 5½ months after baseline (end of treatment).
measure: Change in Whiteley 8 (Assessment of health anxiety)
timeFrame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
measure: Change in PIPS-12 Psychological Inflexibility in Pain Scale
timeFrame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
measure: ECR-RS Experience in Close Relationships - relationship structure
timeFrame: At baseline (i.e. at clinical assessment)
measure: Credibility/ expectancy questionnaire (Assessment of credibility regarding treatment)
timeFrame: App. two weeks after baseline (i.e. at standard psychiatric consultation (SPC))
measure: Life events Questionnaire (Registration of major negative life events)
timeFrame: At baseline (i.e. at clinical assessment)
measure: Other treatment questionnaire (Registration of other received treatment (pharmacological, physiotherapy e.g.)
timeFrame: 12 months after baseline (primary endpoint).
measure: Registration of adverse events
timeFrame: 12 months after baseline (primary endpoint).
Locations:
city: Aarhus
country: Denmark
facility: Research Clinic for Functional Disorders and Psychosomatics
Study officials:
affiliation: Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
name: Charlotte U Rask, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.