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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2019
Source Tel Aviv University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
I-SOCIAL intervention
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.

Locations

Country Name City State
Israel Tel-Aviv University Tel-Aviv

Sponsors (2)

Lead Sponsor Collaborator
Tel Aviv University Ministry for Senior Citizens, Israel

Country where clinical trial is conducted

Israel, 

Outcome

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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