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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33104
Enrollment
20
Registered
2010-02-03
Start date
2010-10-04
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Scleroderma Systemic Sclerosis

Interventions

For the multidisciplinary intervention, available interventions are integrated and standardised into an individual, modular and tailored treatment programme. The psychological intervention consists

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary outcome measure is the percentage of patients scoring above the cut-off score of psychological distress after the intervention, compared with controls.

Secondary

MeasureTime frame
Short measures of appearance self-esteem, fear of progression, pain and fatigue are completed before, during and after the intervention in addition to a short measure of depressed mood. Furthermore, after the intervention and at follow-up, measures of physical functioning, coping and cognitions will be completed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)