|- candidate number||5737|
|- NTR Number||NTR1809|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mei-2009|
|- Secondary IDs||wc2008-130 EMGO+ institute|
|- Public Title||The effectiveness of Systematic ActivatioMethod as a nursing intervention in inpatient depressed elderly.|
|- Scientific Title||The effectiveness of the Systematic ActivationMethod as a nursing intervention in inpatient depressed elderly.|
|- hypothesis||Approximately 2% of the Dutch elderly population suffers from a major depressive disorder (MDD). Due to a depressed mood and a diminished interest in nearly all activities, MDD has serious consequences for daily living (e.g. withdrawal from social activities and neglecting ones self-care). These consequences can lead to admission to a clinical ward. Activity Scheduling is a useful treatment modality for patients with MDD. It is a brief behavioral treatment for patients with depressive disorder. Research has shown that Activity Scheduling is an effective treatment with an overall effect size of .87. We developed Activity Scheduling as an intervention which can be executed by mental health nurses. Although activity scheduling is a promising intervention there is a little known about the effects of activity scheduling executed within nursing practice.|
|- Healt Condition(s) or Problem(s) studied||Depressive Disorder , Elderly patients|
|- Inclusion criteria||1. Age 60 y and older;|
2. Depressive disorder DSM-IV-tr: codes 296.2x, 296.3x. Diagnose determined with MINI (M.I.N.I interational neuropsychiatric interview, van Vliet et al.2000);
3. Abbility to read and write in Dutch;
4. Approval by means of the informed consent procedure.
|- Exclusion criteria||1. Cognitive problems (score <24 on the Minimal Mental State Examination [MMSE]);|
2. Obssesive compulsive disorder, determined with MINI (M.I.N.I international neuropsychiatric interview van Vliet et al. 2000).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2009|
|- planned closingdate||17-jul-2012|
|- Target number of participants||102|
|- Interventions||Intervention: A short course of 7 weeks. Patients learn:|
1. To reflect on the fluctuations in their mood;
2. To execute pleasant activities randomly;
3. To develop a schedule of pleasant activities;
4. To execute these pleasant activities and monitor their mood simultaneously.
Patients will be guided by nurses.
Control: Care as usual.
|- Primary outcome||Level of depression: Beck Depression inventory (BDI-II), Geriatric Depression Scale (GDS).|
|- Secondary outcome||1. Quality of Life (sf-36);|
2. Costs (TiC-P);
3. Mastery (Pearlin Mastery Scale);
4. Activity level.
|- Timepoints||1. T0 (baseline): Mean BDI-II and GDS score, Costs, Mastery, Activity level, Qol;|
2. T1 (8 weeks after T0):Mean BDI-II and GDS score, Mastery, Qol;
3. T1 (6 months after T0): Mean BDI-II and GDS score, Costs, Mastery, Activity level, Qol.
|- Trial web site||http://www.emgo.nl/projects/project/index.asp?id=867&page=1|
|- CONTACT FOR PUBLIC QUERIES||Drs. F. Clignet|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Pim Cuijpers|
|- Sponsor/Initiator ||Altrecht Institute for Mental Health Care, VU University Medical Center, Hogeschool INHolland|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Altrecht Mental Health Care , Hogeschool INHolland|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||12-mei-2009 - 30-sep-2009|