Evaluation of a tailored psychological intervention as component of multidisciplinary treatment for patients with Systemic Sclerosis and elevated levels of distress

Recruiting

• Conditions: Scleroderma; Systemic Sclerosis; 10010761; 10027946

• Registration Number: NL-OMON33104
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. High distress at two consecutive assessments (6 months between assessments): CES-D >= 16.
2. High score ( >0.5 SD above average of cohort) on at least one of the following questionnaires: Appearance Self Esteem, Fear of Progression, Pain or Fatigue.

Exclusion Criteria

1. Serious psychiatric co-morbidity
2. Major organ failure: (chronic) organ insufficiency, that needs major intervention like dialysis or lung transplantation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is the percentage of patients scoring above the cut-off<br /><br>score of psychological distress after the intervention, compared with controls. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Short measures of appearance self-esteem, fear of progression, pain and fatigue<br /><br>are completed before, during and after the intervention in addition to a short<br /><br>measure of depressed mood. Furthermore, after the intervention and at<br /><br>follow-up, measures of physical functioning, coping and cognitions will be<br /><br>completed.</p><br>