Loneliness Clinical Trial
— I-SOCIALOfficial title:
Increasing Social Competence and Social Integration of Older Adults Experiencing Loneliness
| NCT number | NCT01842984 |
| Other study ID # | 300009673 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2013 |
| Est. completion date | December 2018 |
| Verified date | October 2019 |
| Source | Tel Aviv University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
Inclusion Criteria: - age 65 or over - residing in the Tel Aviv region Exclusion Criteria: - having known mental illness including schizophrenia, depression, bipolar disorder, and dementia |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Tel-Aviv University | Tel-Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Tel Aviv University | Ministry for Senior Citizens, Israel |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 Based on experience from another study (Cohen-Mansfield et al., 2013) one item ("I am unhappy being so withdrawn") was replaced with two items ("I feel physically distant from other people"; "I feel emotionally distant from other people). | Participants will be assessed before and after the intervention, an expected average of 6 months |
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