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Rehabilitation through selfmanagement for outpatients with chronic anxiety and depression.


- candidate number11291
- NTR NumberNTR3335
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mrt-2012
- Secondary IDsNL33674.097.10 / 10.218; CCMO / METiGG
- Public TitleRehabilitation through selfmanagement for outpatients with chronic anxiety and depression.
- Scientific TitleRehabilitation through selfmanagement for outpatients with chronic anxiety and depression.
- ACRONYMZemCAD (Zelfmanagement voor Chronische angst en depressie)
- hypothesisTo examine the cost-effectiveness of a treatment protocol focused on self management rehabilitation followed by replacement in primary care for patients with chronic depression and/or anxiety who are currently being treated in secondary care.
- Healt Condition(s) or Problem(s) studiedSelfmanagement, First line therapy, Second line care, Chronic anxiety, Chronic depression
- Inclusion criteria1. Patients with chronic anxiety or depression (>2 years) according to DSM-IV (MINI interview);
2. > 18 years;
3. > 2 years specialist mental healt care;
4. Currently supportive treatment;
5. Treatment resistant.
- Exclusion criteria1. Bipolar disorder;
2. Psychotic disorder;
3. Not fluent in dutch language;
4. Cognitive problems / (IQ <80);
5. Dementia;
6. Alcohol/drugs dependence;
7. Life-threatening medical condition.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2010
- planned closingdate31-dec-2013
- Target number of participants180
- InterventionsA self management protocol provided by a trained psychiatric nurse in secondary care. During 13 sessions in 26 weeks patients form an action plan to re-establish social contacts, improve their daily living activities, patients and their families are educated about the nature of their chronic disorder, suicidality, crises and they learn how to cope with these issues. At the end of this protocol, patients are guided in their replacement in primary care. Professionals working in primary care who will be taking over care for participating patients, will be educated about a model of collaborative care for patients with chronic depression or anxiety. Every primary care practice has to select a mental health professional (psychiatric nurse, social worker or psychologist) who functions as a care manager. This care manager works in close collaboration with the general practitioner and actively monitors functioning of the patient. The general practitioner will be responsible for prescription of medication. Both care manager and general practitioner have easy access to the advice of a consultant psychiatrist who is already familiar with the patient and are provided with a protocol for crisis situations. The process of replacement to primary care will be guided by the psychiatric nurse from secondary care. A qualitative study alongside this randomized controlled trial will be conducted to examine experiences of patients with the intervention in greater detail.

The control group will receive care as usual.
- Primary outcomePrimary outcome measure will be global quality of life as measured with the World Health Organization Quality of Life instrument, Brief version (WHOQOL-BREF).
- Secondary outcomeSecondary outcome measure will be costs, measured with the Trimbos/iMTA questionnaire for psychiatric disorders, according to a societal perspective, thus involving medical costs and productivity costs. Furthermore, depressive and anxiety symptoms will be measured with the Patient Health Questionnaire- 9 (PHQ-9) and the Beck Anxiety Inventory (BAI) respectively. Since empowerment of patients is also an aim of this intervention, this will be assessed using the Dutch empowerment questionnaire (Boevink, Kroon, & Giesen, 2009). Possible confounders such as demographic variables and chronic diseases will be measured at baseline. Measurements will take place at baseline, after 6 months and after 18 months. Considering the qualitative study, experiences of patients will be examined using semi-structured, individual interviews, three months after ending the self management protocol.
- Timepoints1. Baseline;
2. First follow-up (6 mnths);
3. Second follow-up (18 mnths).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J. Spijker
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J. Spijker
- Sponsor/Initiator Trimbos-institute - Netherlands Institute of Mental Health and Addiction
- Funding
(Source(s) of Monetary or Material Support)
Innovatiefonds zorgverzekeraars
- PublicationsN/A
- Brief summaryRationale:
A significant group of patients treated in secondary care is considered to suffer from chronic depression and/or anxiety. These patients have not responded to several evidence based treatments and are currently being treated by a psychiatric nurse in "supporting contacts". This form of care is expensive and not evidence based. Treatment focused on self management rehabilitation and eventually replacement in primary care with specialty back up (collaborative care) might improve patients quality of life and be more efficient and (cost-) effective.

Objective:
To examine the cost-effectiveness of a treatment protocol focused on self management rehabilitation followed by replacement in primary care for patients with chronic depression and/or anxiety who are currently being treated in secondary care.

Study design:
A randomized controlled trial with intervention group (self management protocol, provided by a trained psychiatric nurse, followed by replacement with specialty back-up in primary care) and the control group (continuation of usual care, with the possibility of following the self management protocol after the end of the study period). In addition to the RCT a qualitative study will be performed to gain insight in experiences of patients with the intervention.

Study population:
Patients with chronic anxiety or depression (>2 years) who have received several evidence based treatments (at least one psychological treatment and at least three medication steps), have not responded to these treatments and are currently being treated in secondary care by a psychiatric nurse in "supporting contacts".

Intervention:
A self management protocol provided by a trained psychiatric nurse in secondary care. At the end of this protocol, patients are guided in their replacement in primary care. Professionals working in primary care who will be taking over care for participating patients, will be educated about a model of collaborative care for patients with chronic depression or anxiety.

Main study parameters/endpoints:
Primary outcome measure will be global quality of life as measured with the World Health Organization Quality of Life instrument, Brief version (WHOQOL-BREF). Secondary outcome measure will be costs, measured with the Trimbos/iMTA questionnaire. Depressive and anxiety symptoms will be measured with the Patient Health Questionnaire- 9 (PHQ-9) and the Beck Anxiety Inventory (BAI) respectively. Empowerment will be assessed using the Dutch empowerment questionnaire (Boevink, Kroon, & Giesen, 2009). Measurements will take place at baseline, after 6 months and after 18 months. Considering the qualitative study, experiences of patients will be examined using semi-structured, individual interviews, three months after ending the self management protocol.
- Main changes (audit trail)
- RECORD7-mrt-2012 - 23-mrt-2012


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