The aim of the present study is to evaluate the efficacy of a protocol for cognitive behavioral treatment (CBT) of psychological distress as a component of multidisciplinary treatment in SSc on psychological distress.
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the percentage of patients scoring above the cut-off
score of psychological distress after the intervention, compared with controls.
Secondary outcome
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.
Background summary
Systemic Sclerosis or scleroderma (SSc) 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. Only recently it has become clear which stressors are most important
in SSc, and which psychological mechanisms are related to psychological
distress in SSc. Therefore, these new insights have cleared the way for the
development of integrated, systematic multidisciplinairy interventions for SSc.
Study objective
The aim of the present study is to evaluate the efficacy of a protocol for
cognitive behavioral treatment (CBT) of psychological distress as a component
of multidisciplinary treatment in SSc on psychological distress.
Study design
The effect of the psychological component of multidisciplinary treatment will
be evaluated in a controlled trial. In addition, a series of single-case
experiments will be conducted.
Intervention
For the multidisciplinary intervention, available interventions are integrated
and standardised into an individual, modular and tailored treatment programme.
The psychological intervention consists of 11 individual sessions of cognitive
behavioural therapy. Psychological treatment modules are developed for the most
salient stressors in SSc. Together, patient and therapist will choose which
modules are relevant for the individual patient. In addition, individual
physical therapy, occupational therapy and/or specialized nurse care will bebe
provided using evidence- based methods and best practice guidelines.
Study burden and risks
For this study, patients are invited to an integrated, multidisciplinary
intervention. The burden of the study contains completing questionnaires (two
questionnaires of 1 tot 1,5 hours per questionnaire and 45 short questionnaires
of 2-5 minutes each). Questionnaires are used of which it is plausible that
they are not experienced as insulting or incriminatory , so the burden of
completing the questionnaires will only contain time.
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Hengstdal 3
6522JV Nijmegen
NL
Hengstdal 3
6522JV Nijmegen
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL28603.091.09 |
| OMON | NL-OMON23309 |