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ROM-GPS: Routine Outcome Monitoring for Geriatric Psychiatry & Sciences; a cohort study of older patients with depressive, anxiety or somatic symptom disorders referred for specialised mental health care


- candidate number28297
- NTR NumberNTR6874
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2017
- Secondary IDsNL47717.042.14 ABRnr.
- Public TitleROM-GPS: Routine Outcome Monitoring for Geriatric Psychiatry & Sciences; a cohort study of older patients with depressive, anxiety or somatic symptom disorders referred for specialised mental health care
- Scientific TitleROM-GPS: Routine Outcome Monitoring for Geriatric Psychiatry & Sciences; a cohort study of older patients with affective disorders referred for specialised mental health care
- ACRONYMROM-GPS
- hypothesisAffective disorders, encompassing unipolar depressive disorders, anxiety disorders and somatic symptom disorders, are the most prevalent psychiatric disorders in later life. Treatment protocols and guidelines largely rely on randomized controlled trials conducted in younger age samples. Moreover, studies in geriatric psychiatry are often limited to the “younger olds” and rarely include frail of cognitive impaired older adults. Therefore, the impact of ageing characteristics on the effectiveness of treatment in routine clinical care for older patients is largely unknown.
The primary aim of the Routine Outcome Monitoring for Geriatric Psychiatry & Science (ROM-GPS) is to examine the impact of ageing characteristics on the effectiveness of routinely delivered psychiatric care in specialised mental health care for older patients with affective disorders.
- Healt Condition(s) or Problem(s) studiedSomatic symptoms, Anxiety disorders, Mood disorders
- Inclusion criteriaInclusion criteria are 1) 60 years or older, 2) referred to one the participating outpatient clinics for specialised mental health care, 3) presence of an affective disorder confirmed by the Mini International Neuropsychiatric Interview-Plus (MINI-Plus), and 4) given informed consent.
- Exclusion criteriaExclusion criteria are 1) an established diagnosis of a neurodegenerative disorder or less than 18 points on the Montreal Cognitive Assessment (MoCA) test, 2) a (history of a) bipolar or psychotic disorder, 3) a severe substance-use disorder in need of specialised treatment, 4) physically or mentally too handicapped to administer self-report questionnaires or perform cognitive testing, or 5) insufficient mastery of the Dutch language.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate31-dec-2021
- Target number of participants600
- InterventionsRoutinely provided treatments in outpatient geriatric mental health care are registered
- Primary outcomeThe primary outcome is remission of the index affective disorder at one-year follow-up or end of treatment (if earlier)
- Secondary outcomeSecondary outcomes include the course of symptom severity of the index disorder and of functional limitations
- TimepointsTimepoints are: screening and baseline assessment (if included) at intake in outpatient mental health care, four-monthly postal questionnaires during treatment, one-year follow-up assessment (or at end of treatment if earlier), and two-year follow-up assessment.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr Rob Brink, van den
- CONTACT for SCIENTIFIC QUERIESdr Rob Brink, van den
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), GGZ Drenthe, GGZ Centraal, GGZ Noord-Holland-Noord, GGNet, Pro Persona, Mediant
- PublicationsOude Voshaar RC, D’Hondt T, Naarding P, Smeets M, Lugtenburg A, Marijnissen RM, Hendriks GJ, Verlinde L, Van den Brink RHS. Study design of the Routine Outcome Monitoring for Geriatric Psychiatry & Sciences (ROMG-GPS) project; A cohort study of older patients with affective disorders referred for specialised mental health care. (Submitted).
- Brief summaryBackground – Affective disorders, encompassing unipolar depressive disorders, anxiety disorders and somatic symptom disorders, are the most prevalent psychiatric disorders in later life. Treatment protocols and guidelines largely rely on randomized controlled trials conducted in younger age samples. Moreover, studies in geriatric psychiatry are often limited to the “younger olds” and rarely include frail of cognitive impaired older adults. Therefore, the impact of ageing characteristics on the effectiveness of treatment in routine clinical care for older patients is largely unknown.
Objective - The primary aim of the Routine Outcome Monitoring for Geriatric Psychiatry & Science (ROM-GPS) is to examine the impact of ageing characteristics on the effectiveness of routinely delivered psychiatric care in specialised mental health care for older patients with affective disorders.
Methods – ROM-GPS is a two-stage project, screening all patients referred to one the participating outpatient clinics for specialised mental health care with the Mini International Neuropsychiatric Interview and some symptom severity scales. Patients with a depressive, anxiety or somatic symptom disorder will be asked informed consent and extensively phenotyped at baseline and closely monitored during their first year of treatment. In addition to a large test battery of potential confounders, specific attention is paid to cognitive functioning (including computerized tests with the cogstate test battery as well as paper and pencil test) and physical functioning (including multimorbidity, polypharmacy, the physical frailty phenotype as well as the much broader Tilburgse Frailty indicator).
- Main changes (audit trail)
- RECORD5-dec-2017 - 16-dec-2017


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