Main objective: to get insight in the effectivity of the SAM on depressive symptoms, quality of life, activity level, mastery and costs compared to treatment as usual in clinical admitted depressive elderly.Sedundary objective: to get an insight in…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
depressive symptoms (geriatric depression schale [GDS] and Montgommery Asberg
Depression rating Scale [MADRS]),
Quality of life, (MOS 36 items Short Forms Health Survey [SF-36]),
Mastery (Pearlin Mastery Scale),
Costs (Trimbos/iMTA questionnaire for costs associated with Psychiatric Illness
[Tic-P]),
Activty level.
Secondary outcome
Factors of implementation
Background summary
About 2% of the Dutch elderly population suffers from a major depressive
disorder (MDD). A 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. It is a brief behavioural treatment for a depressive
disorder. Research has shown that Activity Scheduling is an effective treatment
with an overall effect size of .87. We developed Activity Scheduling is an
intervention which can be executed by mental health nurses. The intervention is
a short course in which the patients learn the influence of pleasant activities
on their mood. It is called the Systematic Activation Method (SAM). The nurses
will be trained to guide the participants throughout the course. Although
activity scheduling is a promising intervention there is a little known about
the effects of activity scheduling executed by nurses.
Study objective
Main objective: to get insight in the effectivity of the SAM on depressive
symptoms, quality of life, activity level, mastery and costs compared to
treatment as usual in clinical admitted depressive elderly.
Sedundary objective: to get an insight in the factors which influence the
implementation of the SAM
Study design
Study design: This study will be performed as a multicentre randomized clinical
trial. Five mental health institutions will be selected. On each of these
institutions 2 units will be selected for inclusion (elderly, the wards are
treatment units, nursing staff > 3FTE). The units will be matched for
concurrent treatments (Cognitive Behavioral therapy), and the matched units
will be randomized to an experimental and a control unit. Patients will be
randomized at unit level. With an estimated effect size of .7, *=.5, *=.8,
estimated dropout =25% and 25% extra inclusion due to randomisation at unit
level there will be 102 included in the study (51 per condition).
After a short training, Activity Scheduling will be executed by mental health
nurses on the experimental unit as an additive treatment to treatment as usual
(TAU). On the control unit TAU is provided. Effects will be measured at the T0=
baseline, T1= 10 weeks after T0 and T1= 3 months after T1.
Intervention
The SAM is a short course of 7 weeks which will be followed by the patients.
the course contain the following steps: reflection on mood fluctuations,
execute pleasant activities randomly, to develop and execute a pleasant
activity schedule and the use of resources. the nurses wille be trained to
guide the patients throughout the course.
Study burden and risks
Extend of burden: a 7 weeks course and 5 -10min of homework every day.
Risks: none
van der Boechorststraat 1
1081 BT Amsterdam
NL
van der Boechorststraat 1
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- age 60 y and older,
- 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)
- abbility to read and write in Dutch,
- approval by means of the informed consent procedure
Exclusion criteria
- cognitive problems (score <24 on the Minimal Mental State Examination [MMSE])
- obssesive compulsive disorder, determined with MINI (M.I.N.I international neuropsychiatric interview van Vliet et al. 2000)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26878.029.09 |