|- candidate number||5005|
|- NTR Number||NTR1609|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-jan-2009|
|- Secondary IDs||MEC-2004-191 METC Erasmus MC|
|- Public Title||Group training for patients with Unexplained Physical Symptoms.|
|- Scientific Title||The (cost-)effectiveness of a cognitive behavioural group training for patients with Unexplained Physical Symptoms (UPS): a randomised controlled trial.|
|- ACRONYM||TOLK (Training Onverklaarde Lichamelijke Klachten)|
|- hypothesis||The cognitive behavioural group training: |
1. increases quality of life;
2. decreases direct costs due to health care utilization;
3. decreases indirect costs due to productivity loss;
4. decreases overall psychological distress.
|- Healt Condition(s) or Problem(s) studied||Somatoform disorder, Unexplained Physical Symptoms, Undifferentiatied Somatoform Disorder, Chronic pain disorder|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-feb-2005|
|- planned closingdate||1-jan-2011|
|- Target number of participants||140|
|- 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.
|- Primary outcome||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 outcome||The secondary outcomes are:|
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.
|- Timepoints||T1: baseline assessment;|
(inclusion: up to September 2008);
T2: assessment after training/waiting list;
T3: assessment three month after training;
T4: assessement one year after training.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Klinisch Psycholoog BIG Lyonne Zonneveld|
|- CONTACT for SCIENTIFIC QUERIES||Klinisch Psycholoog BIG Lyonne Zonneveld|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Medical Psychology and Psychotherapy, Riagg Rijnmond|
(Source(s) of Monetary or Material Support)
|- Brief summary||After medical examination, physicians classify 20 to 74% of patientsí symptoms as Unexplained Physical Symptoms (UPS). When UPS persists, cognitive-behavioural therapy may be considered. The cognitive-behavioural therapy based on the consequences model, in which various forms of psychosocial stress are labelled as consequences rather than causes of UPS, has shown to be more acceptable for patients than a therapy based on a causal model. Eighty percent of the patients with UPS accepted an individual therapy based on this model and effectiveness has been shown when applied in secondary medical care, while only 10% of the mental health referrals leads to treatment. However, when the applicability of this model is examined in primary medical care, the high acceptance showed a drastic drop. We modified the implementation of the consequences model into a standardized training program conducted by Riagg Rijnmond, a mental health institution. In this modified program, we standardised the protocol for the individual therapy suitable for patientsí personal needs into a group training, in which the consequences model is used bottom-up instead of top-down. We assume that this innovative implementation is acceptable to patients, as it legitimates the existence of consequences, in other words, the patients are exonerated. The objective of this randomised controlled study is to assess applicability and (cost-)effectiveness of this particular cognitive behavioural group training. If we show that this group training is applicable and (cost-)effective, more patients with UPS could be served on a (cost-)effective basis.|
|- Main changes (audit trail)|
|- RECORD||1-jan-2009 - 8-feb-2009|