NCT01842984

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

April 22, 2013

Last Update Submit

October 30, 2019

Conditions

Keywords

LonelinessSocial isolationDepressionOlder adultsSocial competenceSocial integration

Outcome Measures

Primary Outcomes (1)

  • 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 Based on experience from another study (Cohen-Mansfield et al., 2013) one item ("I am unhappy being so withdrawn") was replaced with two items ("I feel physically distant from other people"; "I feel emotionally distant from other people).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

Study Arms (2)

I-SOCIAL intervention

EXPERIMENTAL

Participants in this group will have up to 10 personal meetings with activities counselors and several group meetings.

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.

Interventions

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.

I-SOCIAL intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 or over
  • residing in the Tel Aviv region

You may not qualify if:

  • having known mental illness including schizophrenia, depression, bipolar disorder, and dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv University

Tel Aviv, 69978, Israel

Location

MeSH Terms

Conditions

Social IsolationDepressionSocial Skills

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavioral Symptoms

Study Officials

  • Jiska Cohen-Mansfiels, Professor

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Health Promotion, Director- The Minerva Center for the Interdisciplinary Study of the End of Life

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 30, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

October 31, 2019

Record last verified: 2019-10

Locations