|- candidate number||8433|
|- NTR Number||NTR2503|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-sep-2010|
|- Secondary IDs||30613 ABR|
|- Public Title||Disrupting the rhythm of depression using e-mental health.|
|- Scientific Title||Disrupting the rhythm of depression: Cost-effectiveness of an e-mental health self management intervention (E-Self CT) with automated tele-monitoring for recurrent depression.|
|- ACRONYM||Disrupting the rhythm of depression using e-mental health.|
|- hypothesis||It is hypothesized that adding an e-mental health self management intervention (E-Self CT), based on cognitive therapy to Care As Usual (CAU) is clinically superior to CAU alone, for preventing relapse/recurrence in depressive disorder. In addition, we expect that the intervention dominates the comparator condition in terms of cost-effectiveness. |
|- Healt Condition(s) or Problem(s) studied||Depressive Disorder , Cognitive behavior therapy, Prevention, Relapse, e-Mental Health|
|- Inclusion criteria||Participant with a recurrent MDD (DSM-IV-TR) who suffered through at least two previous depressive episodes in the past five years. These participants have to be in remission according to DSM-IV criteria for longer than eight weeks and no longer than two years, and have to have a current score of 10 on the Hamilton Rating Scale for Depression (HRSD). Participants also need to be able to be fluent in Dutch and have to have access to the internet.|
|- Exclusion criteria||1. Current mania or hypomania or a history of bipolar illness;|
2. Psychotic disorder (current and previous);
3. Alcohol or drug misuse;
4. A predominant anxiety disorder for which treatment is obtained.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2010|
|- planned closingdate||1-jan-2014|
|- Target number of participants||268|
|- Interventions||When participants are selected into the intervention group, after randomization, they will receive E-Self CT in addition to CAU, (for example care of a general practitioner, secondary care or no care at all) and this will be compared to CAU alone. The e-mental health intervention consists of an online version of an effective face to face Preventive Cognitive Therapy (PCT), therapist support and monitoring of mood. The internet PCT consists of 8 modules with complementary homework assignments. Every session has a fixed structure. |
|- Primary outcome||Cumulative person-time based incidence of depression relapse/recurrence over 24 months using DSM-IV-TR criteria as assessed by the Structural Clinical Interview for DSM-IV Axis I Disorders (SCID) based on the DSM-IV-TR.
Given the results of previous studies, differential response dependent on number of previous depressive episodes will be examined explicit.|
|- Secondary outcome||1. Number of relapse/recurrence;|
2. Severity: Symptom severity as measured with the Inventory of Depressive Symptomatology (IDS-R);
3. Economic evaluation:
A. Balance between costs and health outcomes with the Quality Adjusted Life Years (QALY) measured with the EQ-5D;
B. Cost data stemming from production losses due to absenteeism and working less efficiently while at work will be collected with the TIC-P.
4. Treatment outcome for participants with co-morbidity with concurrent somatic illnesses assessed by the Health Survey Inquiry and additional questions concerning somatic illnesses;
5. Examining differential predictors of treatment outcome;
|- Timepoints||1. Primary outcome: Cumulative person-time based incidence of depression relapse/recurrence over 24 months using DSM-IV-TR criteria as assessed by the Structural Clinical Interview for DSM-IV Axis I Disorders (SCID, telephonic version) based on the DSM-IV-TR after 3, 12 and 24 months;|
2. Implicit measures: Before start, after 3, 12 and 24 months;
3. Secondary outcomes: Before start, after 6 weeks, 3, 6, 9, 12, 15, 18, 21, 24 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc Gemma Kok|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C.L.H. Bockting|
|- Sponsor/Initiator ||University of Groningen, Clinical Psychology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Major depressive disorder (MDD) is projected to rank second on a list of 15 major diseases in terms of burden in 2030. The major contribution of MDD to disability and health care costs is largely due to its highly recurrent nature. Accordingly, efforts to reduce the disabling effects of this chronic condition should shift to preventing recurrence, especially in patients at high risk of recurrence. Given its high prevalence and the fact that interventions are necessary during the remitted phase of this life long disease, new approaches are needed to prevent relapse in depression and monitor relapse and recurrence as part of a disease management program focused on all stages of MDD. The best established effective and available psychological intervention is cognitive therapy. However, it is costly and not available for all patients. Therefore, we will compare the effectiveness and cost-effectiveness of E-mental health self management CT (E-Self CT) accompanied by SMS based tele-monitoring of depressive symptomatology in addition to care as usual (CAU) versus CAU alone.
To study the (cost) efficiency of E-Self CT in preventing relapse for people in remission of recurrent depression. This hasnít been studied before. Alongside the (cost) efficiency we also study the usefulness of the intervention and for which people in particular E-Self CT is an adequate intervention.
In this study a total of 268 people will participate. This is a randomised controlled clinical trial of two parallel groups comparing (1) E-Self CT in addition to CAU versus (2) CAU alone, with follow-up measurements every 3 months during this two-year study. Randomisation will be stratified for number of previous episodes, type of care as usual and employment status, because these are potential prognostic ally important variables.
Remitted patients presenting with at least two previous depressive episodes in the past five years. Participants need to be able to read in Dutch and have access to the internet. We recruit in primary care (at general practitioners) secondary care (at GGZ institutions) and via media.
When participants are selected (after randomisation) into the intervention group, they will be invited to start with the 8 modules of internet based Preventive Cognitive Training (PCT). In addition to the PCT the mood of participants in the E-Self CT will be monitored with, among other things, text messages and, when needed, questionnaires to detect possible re-occurring depressive symptoms.
|- Main changes (audit trail)|
|- RECORD||10-sep-2010 - 21-sep-2010|