NCT00132197

Brief Summary

The purpose of this study is to determine the effect of specialized treatment (including cognitive therapy, social counselling and a recommendation letter to the patients' primary care physician) on the functional level, emotional problems, and use of health care in patients with chronic medically unexplained symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

3.4 years

First QC Date

July 19, 2005

Last Update Submit

November 11, 2011

Conditions

Somatization Disorder

Keywords

Functional somatic symptomsCognitive behavioral therapysomatization disorderSF-36cost-effectivenessMedically unexplained symptoms

Outcome Measures

Primary Outcomes (1)

  • Physical health measured with The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (aggregate score of the scales physical functioning, bodily pain and vitality)

    Measured at baseline and months 4 (end of treatment), 10 and 16

Secondary Outcomes (2)

  • Psychosocial effect measures: Social level of functioning, emotional disorders, coping strategies measured with relevant sub-scales from the SF-36, WHO-DAS II, CSQ, Symptom Checklist SCL, Whiteley-7

    Measured at baseline and months 4 (end of treatment), 10 and 16

  • Use of health care measured by information from the National Patient Register, the Psychiatric Central Register, the National Health Service Register and The Danish Medicines Agency

    Measured for a period of one year prior to referral (baseline) and a period of one year after treatment

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

1\. Specialised treatment includes cognitive groups therapy in 9 modules of 3,5 hours within 3½ months, in all 31,5 hours, consultancy over the phone to the patients' GPs and tuition in groups headed by an experienced social worker. Detailed treatment manuals are worked out separately for each module. Experienced psychotherapists (clinical psychologists and psychiatrists), who also function as consultants, will do the treatment. The Ph.D.-student functions as co-therapist.

Recommendation of care (letter to general practitioner [GP])PROCEDURE

After the diagnostic assessment the patient does not receive any treatment offers at the research clinic, but the patient and the GP will be informed about the diagnosis, and the GP will receive advice on further treatment possibilities.

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Multiple somatic symptoms from several organ systems, without adequate medical explanation.
  • Moderate to severe influence on daily life.
  • The disorder's functional component can easily be separated from a possible well-defined chronic somatic illness.
  • No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (International Classification of Diseases \[ICD-10\]: F20-29, F30-31, F32.3, F33.3)
  • The condition must have been present for at least 2 years.
  • Patients of Scandinavian origin who understand, read, write and speak Danish.

You may not qualify if:

  • No informed consent.
  • An acute psychiatric disorder that demands other treatment, or if the patient is suicidal.
  • Abuse of narcotics or alcohol and (non-prescribed) medicine.
  • Pregnancy.
  • Current industrial injury case or other action for damages.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Per Fink

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Schroder A, Rehfeld E, Ornbol E, Sharpe M, Licht RW, Fink P. Cognitive-behavioural group treatment for a range of functional somatic syndromes: randomised trial. Br J Psychiatry. 2012 Jun;200(6):499-507. doi: 10.1192/bjp.bp.111.098681. Epub 2012 Apr 26.

    PMID: 22539780DERIVED

Related Links

MeSH Terms

Conditions

Somatoform DisordersMedically Unexplained Symptoms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Per Fink, Dr.Med.Sc.

    The Research Clinic for Functional Disorders, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2005

First Posted

August 19, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

DK(1)