Plain English Summary
Background and study aims
Health problems, losing touch with people and death of a spouse and/or friends can be difficult experiences for the aging population. For these reasons, older people are especially vulnerable to feelings of loneliness and melancholy (sadness). There is a lot of evidence to suggest that feeling lonely and depressed can have a negative effect on physical health and can even lead to premature (early) death. Previous studies have shown that social relationships and active participation in social activities can help to maintain and promote good health in ageing people. This study will provide a range of different programs designed to improve social interaction amongst older people, including exercise, group social activities (such as day trips) and personal counselling sessions helping people to become more resilient and independent. The aim of this study is to find out whether taking part in social activities such as these can help to lower feelings of melancholy and loneliness in people in their late seventies.
Who can participate?
Adults aged between 75 and 79 who live at home and are feeling lonely or melancholy.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given the choice as to whether they would like to take part in an exercise, social activity or personal counselling program. For those who choose the exercise group, participants attend 20 hour-long sessions once a week for six weeks, in which they complete a variety of different exercises in groups led by a sports instructor. For those who choose the social activity groups, participants attend 20 two-hour-long sessions once a week for six weeks, in which they take part in activities such as arts and crafts or day trips. For those who choose the personal counselling group, they are able to meet with a counsellor on a one-to-one basis over the six week period as many times as suits their needs. In these sessions, participants are able to talk to a rehabilitation instructor who helps them to become more independent and take better care of their health and wellbeing. Those in the second group do not receive any additional counselling sessions of any kind during the six weeks of the study. At the start of the study, after the six week counselling period and then 3, 6 and 12 months later, participants in both groups are interviewed in order to find out if there has been any change to their mood and wellbeing.
What are the possible benefits and risks of participating?
Participants who take part in the counselling programs may feel less lonely and happier as they are able to spend time with others in the groups. There are no notable risks of taking part in this study.
Where is the study run from?
The study is run from the GeroCenter Foundation for Aging Research and Development and takes place at Sport Services of Jyväskylä (exercise sessions), Jyväskylä City Library (social activity sessions) and Jyväskylä Central Area Health Centre (personal counselling sessions) in Finland.
When is the study starting and how long is it expected to run for?
June 2008 to June 2010
Who is funding the study?
1. Ministry of Social Affairs and Health (Finland)
2. Finland’s Slot Machine Association (Finland)
Who is the main contact?
1. Professor Riku Nikander (scientific)
2. Mrs Katja Pynnönen (public)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Riku Nikander
ORCID ID
http://orcid.org/0000-0002-2072-0510
Contact details
GeroCenter Foundation for Aging Research and Development
Rautpohjankatu 8
Jyväskylä
40700
Finland
Type
Public
Additional contact
Mrs Katja Pynnönen
ORCID ID
http://orcid.org/0000-0002-3809-153X
Contact details
University of Jyvaskyla
Department of Health Sciences
PO Box 35
Jyväskylä
40014
Finland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of social and physical intervention on mental well-being in people aged between 75 and 79: A randomized controlled trial
Acronym
GoodMood-project
Study hypothesis
1. The six month social and physical intervention decreases depressive symptoms and feelings of loneliness, and increases perceived social togetherness compared to controls
2. The intervention increases quality of life and social and physical activity of participants
Ethics approval
The Ethics Committee of the Central Finland Health Care District, 16/09/2008, ref: 9E/2008
Study design
Single-blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Mental and psychosocial well-being: depressive symptoms, perceived mood and loneliness
Intervention
At baseline, all participants have one counselling meeting before being randomly allocated to intervention and control groups.
Control group: Participants receive no additional counselling for the duration of the study.
Interventions group: Participants are allowed to choose participating either in exercise, social activity, or personal counseling program.
1. Exercise group: Participants attend 20 weekly hour-long sessions guided by municipal sports instructors. The program is planned together with the participants, and the meetings involved various types of exercise.
2. Social activity groups: Participants attend 20 weekly two-hour-long sessions and are conducted by JAMK University of Applied Sciences. The sessions involve activities such as arts and creative methods, aesthetic experiences and day-trips.
3. Personal counseling group: Participants undergo personal counselling delivered by a rehabilitation instructor. The frequency and number of meetings are determined on a case-by-case basis (approximately 4-5 times per participant). The counselling sessions aim to promote subject's resources and self-efficacy with taking responsibility for one's health and well-being.
The total duration of the intervention is six months. Participants in both groups are interviewed at baseline and after six months during the 6-month trial. The follow-up measurements are conducted 3, 6, and 12 months after the intervention ended. In addition, the participants of intervention group have auditory interviews after the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Number of depressive symptoms are measured using the Geriatric Depression Scale at baseline and 6 months (after the intervention).
Secondary outcome measures
1. Perceived mood is measured using the question "How is your mood in general?", response options are: "Always or almost always melancholy", ""sometimes melancholy", or "almost always good", at baseline, 6, 9, 12 and 18 months
2. Feeling of loneliness are measured using the question "Do you feel yourself loneliness?", response options are: "Very rarely or not at all", ""sometimes", "often", or "always almost" at baseline, 6, 9, 12 and 18 months
3. Social togetherness is measured using the Social Provision Scale at baseline and 6 months
4. Subscales of Social Provision Scale: Attachment, Social integration, Guidance, Reliable alliance, Opportunity for nurturance, and Reassurance of worth are measured at baseline 6 months
5. Quality of life is measured using the The World Health Organization Quality of Life (WHOQOL) brief questionnaire at baseline and 6 months
6. Participation in activities outside home is measured at baseline 6 months using the questions “How often do you participate in exercise groups?” and “How often do you have self-directed exercise?”, response options are: “≥5 times per week”, “3-4 per week”, “1-2 times per week”, “less often than once a week”, and “no”. “How often do you participate in activities/hobbies outside home such as day care centers, organizations, clubs, activities in congregation, theatre, exhibitions, museums, library?”, response options are: “Daily or almost daily”, “at least once a week”, “2-3 times in month”, “once a month”, “few times in year”, “less often”, or “not at all”
Overall trial start date
01/06/2008
Overall trial end date
01/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 75 and 79 years
2. Community-dwelling
3. Feeling loneliness and/or melancholy at least sometimes
4. Mini Mental State Examination (MMSE) score over 21
5. Willing to participate
Participant type
Other
Age group
Senior
Gender
Both
Target number of participants
Whole population aged 75–79-year-old in the city center area of Jyväskylä in spring 2008, 1 167 persons, were sent information letter on the study. 985 persons were contacted via telephone to screen eligibility for the study. 475 (48 %) of the contacted persons met the inclusion criteria and were invited to participate. Of those 475 persons, 54 % was willing to participate. Thus, with equal allocation the 257 subjects were randomized into intervention (n=129) and control (n=128) groups. 87 % of them continued participating until the end of the study. The most general reasons for refusal were: not interested, considering the study unnecessary for him/herself, or poor health.
Participant exclusion criteria
1. Not feeling lonely and not feeling melancholy
2. Severe memory problems or MMSE < 20
3. Unwillingness to participate
4. Living in an institution
5. Severe health problems
Recruitment start date
02/09/2008
Recruitment end date
19/11/2008
Locations
Countries of recruitment
Finland
Trial participating centre
GeroCenter Foundation for Aging Research and Development
Rautpohjankatu 8
Jyväskylä
40700
Finland
Trial participating centre
Sport Services of Jyväskylä
Kuntoportti 3
Jyväskylä
40700
Finland
Trial participating centre
City Library
Vapaudenkatu 39-41
Jyväskylä
40101
Finland
Trial participating centre
Central Area Health Centre
Tapionkatu 7
Jyväskylä
40100
Finland
Funders
Funder type
Government
Funder name
Sosiaali- ja Terveysministeriö
Alternative name(s)
Ministry of Social Affairs and Health, Social- och Hälsovårdsministeriet
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Finland
Funder name
Finland’s Slot Machine Association
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be published in peer-reviewed international scientific journals e.g. Aging and Mental Health.
Intention to publish date
30/11/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27657351