No registrations found.
ID
Source
Brief title
Health condition
Scleroderma, Depression.
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
After receiving the intervention (SCIN), the depressive symptoms in the scleroderma patients will be decreased.
Study design
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).
Intervention
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.
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2427 |
| NTR-old | NTR2536 |
| CCMO | NL28603.091.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON33104 |