|- candidate number||8274|
|- NTR Number||NTR2436|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jul-2010|
|- Secondary IDs||WS682746 Radboud University Nijmegen|
|- Public Title||Tailored cognitive-behavioral E-health care in patients with psoriasis.|
|- Scientific Title||Tailored cognitive-behavioral E-health care in patients with psoriasis.|
|- ACRONYM||E-health Psoriasis|
|- hypothesis||The aim of the study is to show the effectiveness of tailored cognitive-behavioral E-health care for risk groups of patients with psoriasis in comparison to usual care.|
|- Healt Condition(s) or Problem(s) studied||Psoriasis|
|- Inclusion criteria||1. Diagnosis of definite psoriasis;|
2. Age above 18 years.
|- Exclusion criteria||1. Pregnancy;|
3. Severe physical and/or psychiatric comorbidity that interfere with the study protocol;
4. Current psychological treatments.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2010|
|- planned closingdate||1-jun-2013|
|- Target number of participants||130|
|- Interventions||The intervention of E-health tailored cognitive-behavioral therapy consists of tailored individual treatments with E-health treatment modules that target the most frequently experienced problems which psoriasis patients have to cope with, including coping with itch, fatigue, negative mood and social relationships. Choice of E-health treatment modules are determined based on patient priorities and therapist judgments. All E-health treatment modules consist of cognitive and behavioral elements with homework assignments of about half an hour per day. In all treatment modules, the final booster session deals with relapse prevention and further improvement of the attained goals. For the E-health application, patients have mail contact with the therapist at least once a week. Duration of the treatment is about 6 months.
Patients in the control group will receive standard psoriasis care without E-health or face-to-face tailored cognitive-behavioral care.
|- Primary outcome||The primary outcome is the impact of psoriasis on daily life, including its impact on physical and psychological functioning and daily activities at post-treatment and follow-up measurement at 12 months.
The primary outcome measures are measured as follows:
1. Impact on daily life: Composite scores of:
A. Itch (IHDL, Evers et al., 2007);
B. Fatigue (CIS, Vercoulen et al., 1994).
2. Impact on psychological functioning: Composite scores of:
A. Negative mood (IHDL, Evers et al., 2007);
B. Anxiety (IHDL, Evers et al., 2007);
C. Depression (BDI, Beck et al., 1988).
3. Impact on daily activities:
A. Role limitations due to emotional and physical health problems (SF-36, Ware et al., 1993).
|- Secondary outcome||Secondary outcomes include effects on disease severity as well as compliance with regular care and health care use. |
|- Timepoints||For the treatment group, assessments take place before and after treatment (ca. 6 months later) and at the follow-up measurement 12 months after pre-treatment. For the control group, assessments take place at 0, 6, and 12 months. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. A.W.M. Evers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A.W.M. Evers|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary||In the present project, the effects of tailored E-health cognitive behavioral care are studied for patients with psoriasis. In a randomized controlled trial, psoriasis patients are screened for psychological risk profiles. Patients at risk will be randomized to an E-health cognitive-behavioral treatment or a control condition with care as usual. It is expected that the E-health cognitive-behavioral care will be effective for the impact of the disease on physical and psychological functioning and daily activities at post-treatment and at the follow-up assesment. Secondary outcomes include effects on disease severity as well as compliance with regular care and health care use.|
|- Main changes (audit trail)||13-Mar-2013: Timepoints have changed - NM|
Due to variable duration of treatment length, follow- assessments were anchored on the post-treatment assessment instead of on the pre-treatment assessment for all participants: For the treatment group, assessments take place before and after treatment and at the follow-up measurement 6 months after post-treatment. For the control group, assessments take place at 0, 6, and 12 months.
|- RECORD||30-jul-2010 - 19-mrt-2013|