|- candidate number||8503|
|- NTR Number||NTR2536|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-sep-2010|
|- Secondary IDs||NL28603.091.09 CCMO|
|- Public Title||Evaluation of the intervention SCIN (Scleroderma Interdisciplinary).|
|- Scientific Title||Evaluation of a tailored psychological intervention as component of interdisciplinary treatment for patients with systemic sclerosis and elevated levels of distress. |
|- hypothesis||After receiving the intervention (SCIN), the depressive symptoms in the scleroderma patients will be decreased. |
|- Healt Condition(s) or Problem(s) studied||Depression, Scleroderma|
|- Inclusion criteria||1. Scleroderma, diagnosed by a rheumatologist following the ACR criteria;|
2. High distress at two consecutive assessments (6 months between assessments): Cut-off: CES-D >= 16;
3. High score (> 0.5 SD above average of cohort) on at least one of the following questionnaires: Appearance Self Esteem (ASE), Fear of Progression (FoP);
4. One-way travel time to Sint Maartenskliniek Nijmegen less than 1 hour.
|- Exclusion criteria||1. Life expectancy less than 1 year;|
2. Acute serious complications;
3. Serious psychiatric co-morbidities;
4. Other serious co-morbidities;
5. Insufficient knowledge of the Dutch language;
6. Major organ failure.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-nov-2010|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||12|
|- Interventions||The intervention consists of 10 CBT sessions in 14 weeks. The overall goal is decreasing depression. Furthermore the psychological intervention will be individual, modular and tailored to the patients' most important stressor (ASE or FoP). In addition, individual physical therapy, occupational therapy and/or specialized nurse care will be given using evidence-based methods and best practice guidelines. |
|- Primary outcome||The primary outcome measure is depression. This is measured using a combined score (mean) of two VAS questionnaires measuring depression. These measures will be completed twice a week before, during and after the intervention to assess whether this variable change over time. |
|- Secondary outcome||Data will be collected in two different manners:|
1. 8 Visual Analogue Scales;
2. A set of questionnaires.
The secondary outcome measures are visual analogue scales of Appearance Self Esteem (ASE), Fear of Progression (FoP), pain and fatigue.
The set of questionnaires consists of 9 questionnaires on coping, physical functioning, depression, anxiety, ASE and FoP.
|- Timepoints||The 8 VAS questionnaires will be completed twice a week, starting after the intake. In total the VAS questionnaires will be completed 47 times.|
The set of questionnaires will be completed at timepoints T0 (before intervention), T1 (after intervention) and T2 (6 months after intervention).
|- Trial web site|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc Linda Kwakkenbos|
|- CONTACT for SCIENTIFIC QUERIES||MSc Linda Kwakkenbos|
|- Sponsor/Initiator ||Sint Maartenskliniek Nijmegen|
(Source(s) of Monetary or Material Support)
|Sint Maartenskliniek Nijmegen|
|- Publications||Kwakkenbos L, Willems LM, van den Hoogen FHJ, van Lankveld WGJM, Beenackers H, van Helmond TF, Becker ES, van den Ende CHM. Cognitive-behavioural therapy targeting fear of progression in an interdisciplinary care program: a case study in systemic sclerosis. J Clin Psychol Med Settings. In press.|
|- Brief summary||Scleroderma has serious negative consequences for the patient. Elevated levels of depression are observed in 36 to 65% of the patients. There is a growing recognition that these psychological problems should be treated, in addition to regular and ongoing medical and paramedical treatment. Recently it became clear that Appearance Self Esteem and Fear of Progression are important stressors in scleroderma. The aim of this study is to evaluate the efficacy of a protocol for cognitive behavioral treatment (CBT) of psychological distress as a component of multidisciplinary treatment in scleroderma on psychological distress. This will be evaluated using a multiple-baseline single-case design. |
|- Main changes (audit trail)|
|- RECORD||28-sep-2010 - 29-okt-2014|