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Trial record 11 of 293 for:    "Somatoform Disorder"

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

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ClinicalTrials.gov Identifier: NCT02346071
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : January 4, 2019
Sponsor:
Collaborators:
Karolinska University Hospital
National Research Centre for the Working Environment, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Somatization Disorder Somatoform Disorders Behavioral: Acceptance and Commitment Therapy Other: Enhanced Usual Care (EUC) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes: Randomized Trial
Actual Study Start Date : January 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Active Comparator: Enhanced Usual Care (EUC)
Clinical psychiatric and somatic assessment. Standard psychiatric consultation (SPC) given 2 weeks after randomization.
Other: Enhanced Usual Care (EUC)

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.


Experimental: Acceptance and Commitment Therapy (ACT)
Clinical psychiatric and somatic assessment. Standard psychiatric consultation (SPC) given 2 weeks after randomization. ACT-based group therapy.
Behavioral: Acceptance and Commitment 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 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.





Primary Outcome Measures :
  1. 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. ]
    Questionnaire, patient rated. Physical health measured with aggregate scores of the scales PF (physical functioning), BP (bodily pain) and VT (vitality).


Secondary Outcome Measures :
  1. Change in BDS checklist (Assessment of symptom severity) [ Time Frame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint). ]
    Questionnaire, patient rated. Assessment of symptom severity.

  2. Change in SCL-somatization Questionnaire (Assessment of functional symptoms) [ Time Frame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline. ]
    Questionnaire, patient rated. Assessment of functional symptoms.

  3. Change in Limitation index Questionnaire (Assessment of symptom interference) [ Time Frame: At baseline (i.e. at clinical assessment) and 5½, 8 and 12 months after baseline (primary endpoint). ]
    Questionnaire, patient and parent rated. Assessment of symptom interference.

  4. PGIC (Patient Global Impression of Change) [ Time Frame: At 5½, 8 and 12 (primary endpoint) months after baseline. ]
    Questionnaire, patient and parent rated.

  5. Change in SF36 Questionnaire (Assessment of health related quality of life) [ Time Frame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline. ]
    Questionnaire. Patient rated. Assessment of health related quality of life using Social Functioning Scale and Mental Health Scale.

  6. Change in SCL-8, SCL-6, SCL-4 Questionnaire (Assessment of depression and anxiety) [ Time Frame: At baseline (i.e. at clinical assessment) and 5½, 8 and 12 (primary endpoint) months after baseline . ]
    Questionnaire, patient rated. Assessment of depression and anxiety.

  7. Change in HRV heart rate variability (assessment of stress response in various situations (resting state, standing, slow breathing and valsalva) [ Time Frame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint). ]
    Physiological assessment of stress response in various situations (resting state, standing, slow breathing and valsalva).

  8. Change in hair cortisol (Measurement of the level of stress-hormone cortisol in hair) [ Time Frame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint). ]
    Measurement of the level of stress-hormone cortisol in hair.

  9. Change in level of inflammatory and oxidative stress [ Time Frame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint). ]
    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).

  10. Level of physical activity (Anthropometric measurements with accelerometer (Actigraph GT3X) [ Time Frame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint). ]
    Anthropometric measurements with accelerometer (Actigraph GT3X), duration 1 week (24h/day).

  11. Change in PSS (Perceived Stress Scale) [ Time Frame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint). ]
    Questionnaire, patient rated. Assessment of self perceived stress level.


Other Outcome Measures:
  1. Change in AFQ-Y8 (Avoidance and Fusion Questionnaire in Youth) [ Time Frame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline. ]
    Questionnaire, patient rated. Assessment of psychological flexibility. Process measure.

  2. Change in IPQ-R Illness Perceptions Questionnaire [ Time Frame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline. ]
    Questionnaire, patient rated. Process measure.

  3. Change in BRIQ Behavioural Responses to Illness Questionnaire [ Time Frame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline. ]
    Questionnaire, patient rated. Assessment of illness related behaviour. Process measure.

  4. FAD Family Assessment Devise [ Time Frame: At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint). ]
    Questionnaire, patient and parent rated. Assessment of general family functioning. Moderator.

  5. ESQ Experience of Service Questionnaire [ Time Frame: 5½ months after baseline (end of treatment). ]
    Questionnaire, patient rated. Only given to patients in group based therapy. Assessment of their treatment experience.

  6. Change in Whiteley 8 (Assessment of health anxiety) [ Time Frame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline. ]
    Questionnaire, patient rated. Assessment of health anxiety. Process measure.

  7. Change in PIPS-12 Psychological Inflexibility in Pain Scale [ Time Frame: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline. ]
    Questionnaire, patient rated. Assessment of psychological inflexibility. Process measure.

  8. ECR-RS Experience in Close Relationships - relationship structure [ Time Frame: At baseline (i.e. at clinical assessment) ]
    Questionnaire, patient rated. Assessment of attachment style. Moderator.

  9. Credibility/ expectancy questionnaire (Assessment of credibility regarding treatment) [ Time Frame: App. two weeks after baseline (i.e. at standard psychiatric consultation (SPC)) ]
    Questionnaire, patient rated. Assessment of credibility regarding treatment.

  10. Life events Questionnaire (Registration of major negative life events) [ Time Frame: At baseline (i.e. at clinical assessment) ]
    Questionnaire, patient rated. Registration of major negative life events.

  11. Other treatment questionnaire (Registration of other received treatment (pharmacological, physiotherapy e.g.) [ Time Frame: 12 months after baseline (primary endpoint). ]
    Questionnaire, patient rated. Registration of other received treatment (pharmacological, physiotherapy e.g.) during the follow-up period.

  12. Registration of adverse events [ Time Frame: 12 months after baseline (primary endpoint). ]
    Questionnaire, patient rated. Registration of potential adverse events during follow up period.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346071


Locations
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Denmark
Research Clinic for Functional Disorders and Psychosomatics
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Karolinska University Hospital
National Research Centre for the Working Environment, Denmark
Aarhus University Hospital
Investigators
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Principal Investigator: Charlotte U Rask, MD, PhD Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02346071     History of Changes
Other Study ID Numbers: CURKHK1
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: May 2018

Keywords provided by University of Aarhus:
Bodily distress syndrome
Medically unexplained symptoms
Functional somatic symptoms
Functional somatic syndromes
Treatment
Acceptance and Commitment Therapy

Additional relevant MeSH terms:
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Disease
Syndrome
Somatoform Disorders
Pathologic Processes
Mental Disorders