The effectiveness of looking for meaning, a life-review course for elderly with depressive symptoms. A randomised controlled trial.

ISRCTN	ISRCTN66645855
DOI	https://doi.org/10.1186/ISRCTN66645855
Protocol serial number	NTR541
Sponsor	Trimbos Institute - Netherlands Institute of Mental Health and Addiction (Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Submission date: 14/02/2006
Registration date: 14/02/2006
Last edited: 17/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A.M. Pot
Scientific

Trimbos-institute
Netherlands Institute of Mental Health and Addiction
P.O. Box 725
Utrecht
3500 AS
Netherlands

Email	ampot@trimbos.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised single blind active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Looking for meaning leads to a significant reduction of depressive symptoms and a significant enhancement of wellbeing, meaning in life and quality of life with elderly with depressive symptoms in comparison to a no treatment control group.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Depressive symptoms
Intervention	The course looking for meaning is the intervention. It is a group-oriented intervention of twelve sessions of two hours, conducted in groups of about ten participants. Based on certain themes, in this intervention participants are invited to take memories from their own lives. The special thing about the course is that reminiscence is linked to creative assignments. Imagination and creativity are viewed as important keys to perceived meaning, competencies and well-being. Via targeted questions, participants evaluate and re-evaluate their own lives. The control group receive no treatment.
Intervention type	Other
Primary outcome measure(s)	1. Depressive symptoms (Centre of Epidemiological Studies-Depression scale [CES-D], Bouma, Ranchor, Sanderman and van Sonderen 1995) 2. Well-being (Well-being Scale, Ryff and Keyes, 1995) 3. Perceived meaning (SELE Scale, Dittmann-Kohli and Westerhof 1997) 4. Quality of life (EuroQol Group 1990)
Key secondary outcome measure(s)	1. Mastery (Pearlin Mastery Scale, Pearlin and Schooler 1978) 2. Social support (van Sonderen et al. 1989) 3. Personality structure (NEO-FFI) 4. Demographic variables and important life events
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	360
Key inclusion criteria	Elderly people above the age of 55 with slight to moderate depressive symptoms.
Key exclusion criteria	1. People with severe depressive symptoms and a CES-D score higher than 24 2. The absence of depressive symptoms, a score lower than 5 on the CES-D 3. People being treated elsewhere (with medication) when they register 4. People unable to function in a group
Date of first enrolment	01/11/2005
Date of final enrolment	01/11/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Trimbos-institute

Utrecht
3500 AS
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/06/2008		Yes	No