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Group training for patients with Unexplained Physical Symptoms.

The (cost-)effectiveness of a cognitive behavioural group training for patients with Unexplained Physical Symptoms (UPS): a randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25959
Enrollment
140
Registered
2009-01-01
Start date
2005-02-17
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Unexplained Physical Symptoms 2. Undifferentiatied Somatoform Disorder 3. Chronic Pain Disorder 4. Somatoform Disorders Onverklaarde Lichamelijke Klachten Ongedifferentieerde Somatoforme Stoornis Pijnstoornis Somatoforme Stoornissen

Interventions

The experimental condition is a cognitive behavioural group training consisting of thirteen ad verbatim protocollised weekly sessions of two hours each. The control condition is a waiting list.

Sponsors

drs. J. Lamé, Board of Directors Riagg Rijnmond Westhavenkade 85 3133 AV Vlaardingen The Netherlands Prof. dr. J. Passchier, supervisor of the Ph.D.student Erasmus MC Department of Medical Psychology and Psychotherapy PO Box 2040 3000 CA Rotterdam The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years; 2. being able to speak, read and write Dutch; 3. at least 6 months duration of the Unexplained Physical Symptoms (UPS); 4. UPS can be classified as DSM-IV-TR Undifferentiated Somatoform Disorder or Pain Disorder; 5. written informed consent.

Exclusion criteria

Exclusion criteria: 1. Undifferentiated Somatoform Disorder or Chronic Pain Disorder is not the principal DSM-IV-TR classification; 2. UPS is not the principal somatic disease; 3. handicaps like cognitive mental impairment and blindness hinder the patient to participate in the training.

Design outcomes

Primary

MeasureTime frame
The primary outcome is effectiveness of the group training. This effectiveness is operationalised with quality of life. Quality of life is measured with the 36-item Short Form Health Survey (SF-36), which is administered at baseline, after the group therapy/waiting list, 3 months after the group training and one year after the group training.

Secondary

MeasureTime frame
The secondary outcomes are: 1. cost-effectiveness; 2. overall psychological distress. 1. Cost-effectiveness consists of direct costs due to health care utilization and indirect costs due to productivity loss. Cost-effectiveness is measured with the Trimbos/iMTA Questionnaire for Costs associatied with Psychiatric Illness (TiC-P). The TiC-P is administered at baseline, after the group therapy/waiting list, 3 months after the group training and one year after the group training. 2. Overall psychological distress consists of a broad range of physical and psychological symptoms and theirs intensity. Overall psychological distress is measured by the Symptom Checklist Revised (SCL-90-R). The SCL-90-R is administered at baseline, after the group therapy/waiting list, 3 months after group training and one year after the group training.

Contacts

Public ContactLyonne Zonneveld

(Riagg Rijnmond Westhavenkade 85 3133 AV Vlaardingen The Netherlands) Erasmus MC Department of Medical Psychology and Psychotherapy PO Box 2040

LZonneveld@riaggrijnmond.nl(+31) 10 4453426

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)