LonelinessI-SOCIALNCT01842984
Decreasing Loneliness in Older Adults
A study testing I-SOCIAL intervention in people with Loneliness and Social Isolation, run by Tel Aviv University at 1 site in Israel.
Trial summary
The purposes of this study are: (1) decrease loneliness and social isolation and increase social competence and social integration of older adults experiencing loneliness; (2) examine an intervention process grounded in a theoretical model that was developed in a previous study. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Social Isolation
- What is being tested?
- I-SOCIAL intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 or over
- residing in the Tel Aviv region
Who cannot join
- having known mental illness including schizophrenia, depression, bipolar disorder, and dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Social Competence and Social Integration of Older Adults Experiencing Loneliness
The purposes of this study are: (1) decrease loneliness and social isolation and increase social competence and social integration of older adults experiencing loneliness; (2) examine an intervention process grounded in a theoretical model that was developed in a previous study. The intervention process is tailored to the participants' barriers and abilities, and includes up to 10 personal meetings with an activities counselor and several group meetings.
- Conditions
- Loneliness, Social Isolation
- Being tested
- I-SOCIAL intervention
- Keywords
- Loneliness, Social isolation, Depression, Older adults, Social competence, Social integration
- Medical subject headings
- Social Isolation, Depression, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-SOCIAL interventionBehavioural
The I-SOCIAL intervention is based on findings from Cohen-Mansfield and Parpura-Gill (2007), which highlighted the important role of barriers in contributing to loneliness in older persons. These barriers include a perceived lack of opportunities for social contacts, low social self-efficacy, and health and mobility difficulties. The intervention includes: (1) identifying the barriers for the specific person; (2) up to 10 meetings with an activities counselor. The meetings include discussions concerning options for social contacts and use of techniques and resources to tackle the barriers; and (3) group meetings of participants and the activities counselors in order to provide a concrete social event and as a venue to discuss barriers and ways to address them.
| Study group | Role | What they receive |
|---|---|---|
| I-SOCIAL intervention | Experimental | Participants in this group will have up to 10 personal meetings with activities counselors and several group meetings. Receives: Behavioral: I-SOCIAL intervention |
| Control group | No intervention | Participants in this group will not have meetings with the activities counselors, and will not take part in the group meetings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Loneliness
Loneliness will be assessed via several measures: (a) Frequency of loneliness will be measured via one item ("How often would you say you feel lonely?"; (Mullins, Woodland, \& Putnam, 1990) on a 6-point scale from "never" (1) to "several times an hour" (6); (b) The UCLA Loneliness Scale- 8 items (ULS-8; (Hays \& DiMatteo, 1987). Each item is rated on a 5-point scale from "not at all" (1) to "to a great extent" (5), with a higher score indicating more loneliness. Based on experience from another study (Cohen-Mansfield et al., 2013) one item ("I am unhappy being so withdrawn") was replaced with two items ("I feel physically distant from other people"; "I feel emotionally distant from other people).
Measured: Participants will be assessed before and after the intervention, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry for Senior Citizens, Israel
- Responsible party
- Principal investigator, Professor Jiska Cohen-Mansfield, Tel Aviv University
- Investigators
- Jiska Cohen-Mansfiels, Professor, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842984
- Sponsor's protocol ID
- 300009673
- Acronym
- I-SOCIAL
- Status last verified
- Oct 2019
- First submitted
- 22 Apr 2013
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Social Competence and Social Integration of Older Adults Experiencing Loneliness
- ClinicalTrials.gov ID
- NCT01842984
- Acronym / sponsor ID
- I-SOCIAL / 300009673
- Conditions
- Loneliness, Social Isolation
- Keywords
- Loneliness, Social isolation, Depression, Older adults, Social competence, Social integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Ministry for Senior Citizens, Israel
- Study start
- Mar 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are: (1) decrease loneliness and social isolation and increase social competence and social integration of older adults experiencing loneliness; (2) examine an intervention process grounded in a theoretical model that was developed in a previous study. The intervention process is tailored to the participants' barriers and abilities, and includes up to 10 personal meetings with an activities counselor and several group meetings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-SOCIAL intervention | Experimental | Behavioral: I-SOCIAL interventionParticipants in this group will have up to 10 personal meetings with activities counselors and several group meetings. |
| Control group | No intervention | –Participants in this group will not have meetings with the activities counselors, and will not take part in the group meetings. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age 65 or over
- residing in the Tel Aviv region
Key exclusion criteria (1 listed)
- having known mental illness including schizophrenia, depression, bipolar disorder, and dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-SOCIAL interventionThe I-SOCIAL intervention is based on findings from Cohen-Mansfield and Parpura-Gill (2007), which highlighted the important role of barriers in contributing to loneliness in older persons. These barriers include a perceived lack of opportunities for social contacts, low social self-efficacy, and health and mobility difficulties. The intervention includes: (1) identifying the barriers for the specific person; (2) up to 10 meetings with an activities counselor. The meetings include discussions concerning options for social contacts and use of techniques and resources to tackle the barriers; and (3) group meetings of participants and the activities counselors in order to provide a concrete social event and as a venue to discuss barriers and ways to address them. | Behavioural | I-SOCIAL intervention |
Primary outcome
Change in Loneliness
Time frame: Participants will be assessed before and after the intervention, an expected average of 6 months
Loneliness will be assessed via several measures: (a) Frequency of loneliness will be measured via one item ("How often would you say you feel lonely?"; (Mullins, Woodland, \& Putnam, 1990) on a 6-point scale from "never" (1) to "several times an hour" (6); (b) The UCLA Loneliness Scale- 8 items (ULS-8; (Hays \& DiMatteo, 1987). Each item is rated on a 5-point scale from "not at all" (1) to "to a great extent" (5), with a higher score indicating more loneliness. Based on experience from another study (Cohen-Mansfield et al., 2013) one item ("I am unhappy being so withdrawn") was replaced with two items ("I feel physically distant from other people"; "I feel emotionally distant from other people).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiska Cohen-Mansfiels, Professor principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-SOCIAL intervention in people with Loneliness and Social Isolation, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Loneliness (time frame: Participants will be assessed before and after the intervention, an expected average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.