The aim of the present research project is to evaluate the (cost-)effectiveness of medical psychological screening and tailored cognitive-behavioral therapy for patients with rheumatoid arthritis with psychological risk profiles through E-health…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the impact of the rheumatic disease on daily life,
including its impact on physical and psychological functioning and daily
activities.
Secondary outcome
Secondary outcomes of cost-effectiveness, disease severity and compliance with
regular rheumatological care are assessed.
Background summary
Research has shown that a part of the patients with rheumatoid arthritis are at
risk for long-term adjustment problems (Evers et al., 2001, 2002, 2003a/b,
2005). Previous research also demonstrated that these risk groups of patients
can be identified by screening with standardized questionnaire assessments at
an early stage of the disease. Research of the project group has also shown
that these problems of this group of high-risk RA patients can be succesfully
treated by tailored cognitive-behavior therapy. An innovative solution for the
regional and national application is to offer this care through E-health, by
systematic screening and tailored cognitive behavior therapy via internet for
patients at risk. Based on the previous research findings, it can be expected
that about 30% of all patients have a psychological risk profile and can
benefit from this type of E-health care of tailored cognitive-behavioral
therapy.
There is increasing evidence that interventions with cognitive-behavioral
therapy for protocolized treatments are about as effective through E-health as
interventions with face-to-face contact for a broad range of psychological
problems, such as anxiety disorders, depression or grief processing (e.g. see
Berstrom et al., 2003; Christensen et al., 2004, Langeet al., 2003). The need
for E-health care and the applicability of psychological E-health programs have
also been examined for patients with chronic physical conditions, such as
chronic pain and functional impairments (Buhrman et al, 2004; Devineni et al.,
2005; Hoppe et al., 2003; van Lankveld et al., 2006). Since the most important
working mechanisms in cognitive-behavior therapy are the same for chronic
physical conditions of RA as for psychological problems, it can be expected
that tailored cognitive-behavior therapy through E-health is also effective for
this patient group. The feasibility of this program has been demonstrated in a
pilot study with patients with rheumatoid arthritis, with CMO registration
number NL21785.091.08.
Study objective
The aim of the present research project is to evaluate the (cost-)effectiveness
of medical psychological screening and tailored cognitive-behavioral therapy
for patients with rheumatoid arthritis with psychological risk profiles through
E-health care in comparison to usual care (care without face-to-face or
E-health cognitive-behavioral therapy).
Study design
Inform
About 600 patients will receive a letter with information about the study.
Screening
Patients who are willing to participate will receive specific information on
the screening with a link to the questionnaires. At home behind their PC they
can fill in the questionnaires. The questionnaires are individually screened
for a psychological risk profile for long-term physical and emotional
adjustments problems. Patients are informed by mail about the results of the
questionnaires. Patients at risk (30%) receive further information about the
treatment with cognitive behavioral therapy, together with an application
form.
The intervention: E-Health treatment
Every patient with a risk profile who is willing to participate will randomly
be assigned to either the treatment group (65 participants) or the control
group (65 participants). Patients who are assigned to the treatment group will
receive E-health care with tailored cognitive-behavior therapy during six
months. Six times both the patients from the intervention and the control group
will fill in standardized questionnaires on the internet.
Intervention
Tailored cognitive-behavioral therapy will be offered through E-health,
consisting of 10 sessions. Two out of five possible treatment modules will be
offered during the treatment, depending on the risk profile of the patients.
The treatment modules are: coping with pain and disability, fatigue, itch,
social relationships and negative mood.
At least once a week chat patients will receive feedback from the therapist
about the assignments, by means of a mail box. Treatment will be conducted by
therapists who are specifically trained in the tailored cognitive-behavioral
protocol.
Study burden and risks
For the participating patients, there are no risks connected to the study. We
only ask the patients to invest some of their time.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients older than 18 years diagnosed with rheumatoid arthritis
Exclusion criteria
Severe physical comorbidity
Psychiatric disorders that interfere with the protocol
Pregnancy
Being without the capability of the dutch language
Ongoing psychological treatment elsewhere
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL24343.091.08 |