|- candidate number||10183|
|- NTR Number||NTR3001|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-jul-2011|
|- Secondary IDs||37685 ABR|
|- Public Title||Prevention of recurrent depression with psychotherapy, led by a primary care nurse.|
|- Scientific Title||Nurse-led self-help for recurrent depression in the primary care setting versus usual care; A pragmatic randomised trial and economic evaluation.|
|- ACRONYM||PARADE-study |
|- hypothesis||It is hypothesized that adding nurse-led self-help to usual care is clinically superior to care as usual alone for preventing recurrence in recurrent depressive disorder. In addition, it is expected that the intervention dominates the comparator condition in terms of cost-effectiveness.|
|- Healt Condition(s) or Problem(s) studied||Family practice/general practice, Recurrent depression, Preventive cognitive therapy, Nurse|
|- Inclusion criteria||1. Age 18-65 year;|
2. At least 2 confirmed previous MDD episodes with the SCID 42 in the last 5 years;
3. The last episode was at least 8 weeks ago, the last episode lasted at least 2 weeks;
4. Current remission according to DSM-IV criteria (a current score of <10 in the 17 item HRSD);
5. Fluent in Dutch.
|- Exclusion criteria||1. Current mania or hypomania or history of bipolar illness;|
2. Any current organic or psychotic disorder;
3. Current or previous hospitalisation for alcohol or drug abuse;
4. Severe sensory disabilities.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-jun-2014|
|- Target number of participants||268|
|- Interventions||The investigational treatment in this trial is ‘nurse-led self-help’ based on preventive cognitive therapy. Patients will be offered a detailed treatment manual of the therapy with literature, backgrounds and assignments. This self-help book will enable patients to follow the course of the therapy in their own homes, in their own time. Prior to the start of the therapy, a face-to-face meeting with the nurse is planned at the primary care practice (at a maximum of 45 minutes). This meeting involves psychoeducation on (the course and treatment of) recurrent depression, and an introduction to the nurse-led self-help therapy on the basis of the treatment manual. Apart from this face to face meeting there is weekly telephone contact (at a maximum of 15 minutes), initiated by the nurse. During these telephone meetings patients are asked several questions abouut their progression with the course, based on a rather strict protocol. |
The intervention is added to care as usual. The control group receives care as usual.
|- Primary outcome||The primary outcome measure is the cumulative incidence of recurrences meeting DSM-IV criteria for a major depressive episode in both arms. Along to this pragmatic trial the cost-effectiveness is measured, defined from a societal perspective meaning that the costs of the intervention, health care uptake, patients' out-of-pocket costs and costs due to productivity losses will be included in the economic evaluation.|
|- Secondary outcome||To study whether nurse-led self-help for patients with recurrent MDD versus usual care alone:|
1. Is (cost-)effective in reducing health care utilisation;
2. Is (cost-)effective in reducing co-morbid distress, anxiety and somatisation;
3. Is satisfying according to patients;
4. Is (cost-)effective in certain subgroups of patients, particularly related to (i.e. modified by):
A. The number of previous episodes;
B. Type of treatment for the last recurrence (AD, psychological intervention, noting etc);
C. The severity of residual depressive symptoms in the remitted phase;
D. Age of onset of the first depressive episode;
E. Social economic status;
F. Self-efficacy for managing depression;
G. Symptoms of pain and/or fatigue.
|- Timepoints||Before randomisation baseline measuremenst are assessed to be able to stratificate to number of previous episodes and type of care received for the last depressive episode. Other demografic data are assessed at baseline as well. During the course of the therapy a weekly Q-IDS-SR is assessed. From the start several questionaires are assessed every 3 months till 15 months follow up.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD Karolien Leliefeld|
|- CONTACT for SCIENTIFIC QUERIES||MD Karolien Leliefeld|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Title; ‘Nurse-led self-help for recurrent depression in the primary care setting versus usual care; a pragmatic randomised trial and economic evaluation’
A randomised controlled trial with randomisation at patient level. There will be two parallel groups to evaluate the costs and effects of nurse-led self-help + usual care for 134 primary care patients with remitted MDD versus 134 controls (usual care) at 3, 6, 9 and 12 and 15 months follow up. Stratification variables will be the number of previous episodes and the type of treatment as usual received for the last episode.
2 or more confirmed depressive episodes in the last 5 years and currently remitted.
Nurse-led self-help preventive cognitive therapy. The patients works through the manual at home. One face to face meeting is held with the nurse prior to the start of the therapy. Then, 8 weekly telephone calls are arranged in order to keep track of the progression of the patient.
The primary outcome measure is the cumulative incidence of recurrences meeting DSM-IV criteria for a major depressive episode in both arms. Along to this pragmatic trial the cost-effectiveness is measured, defined from a societal perspective meaning that the costs of the intervention, health care uptake, patients' out-of-pocket costs and costs due to productivity losses will be included in the economic evaluation.
|- Main changes (audit trail)|
|- RECORD||21-jul-2011 - 2-sep-2011|