Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes
Condition: Somatization Disorder; Somatoform Disorders
MeSH terms: Syndrome; Somatoform Disorders
Study type: Interventional

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.
    

Intervention name(s): Acceptance and Commitment Therapy; Enhanced Usual Care (EUC)
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bodily distress syndrome; Medically unexplained symptoms; Functional somatic symptoms; Functional somatic syndromes; Treatment; Acceptance and Commitment Therapy