Suicidal IdeationPhase 2TSCNCT01408654
Social Connections and Healthy Aging (The Senior Connection)
A Phase 2 study testing Peer Companionship in people with Suicidal Ideation and Depression, run by University of Rochester at 1 site in United States.
Trial summary
This randomized trial compares peer companionship to care-as-usual in primary care on the outcome of risk for suicidal behavior in late life. The investigators hypothesize that older adults assigned to receive peer companionship will report greater social connectedness and less death and suicidal ideation compared to… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Suicidal Ideation, Depression
- What is being tested?
- Peer Companionship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2016
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 or older
- Primary Care Patient
- Endorses feeling lonely and/or like a burden in the the past two weeks
Who cannot join
- Positive dementia screen
- Current alcohol abuse
- Psychosis
- Suicidal ideation with intent to act (current or past month.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester School of Medicine and Dentistry
Rochester, New York, 14642
About this study
This randomized trial compares peer companionship to care-as-usual in primary care on the outcome of risk for suicidal behavior in late life. The investigators hypothesize that older adults assigned to receive peer companionship will report greater social connectedness and less death and suicidal ideation compared to older adults assigned to care as usual.
Read the detailed description
There is a pressing need for interventions that reduce risk for suicide in later life. Older adults in the U.S. have the highest rate of suicide and are the fastest growing segment of the population. The investigators can anticipate a large rise in the number of older adults who die by suicide in coming decades. This application is in response to RFA-CE-10-006. Consistent with the CDC's key strategy of reducing suicide by promoting connectedness, our long-term goal is to reduce late life suicide-related morbidity and mortality by leveraging the resources and expertise of the aging services provider network (ASPN) to address unmet social needs of community-dwelling older adults. Our objectives with this proposal are (1) to examine whether linking socially disconnected seniors with peer supports through the Retired and Senior Volunteer Program (RSVP) is effective in reducing risk for suicide, and (2) to test an hypothesized mechanism for the association of social disconnectedness and suicidal ideation and behavior informed by the Interpersonal Theory of Suicide.
The investigators will recruit 400 primary care patients (200 men and 200 women) over age 60 years who endorse feeling lonely and/or as if they are a burden on others. They will be randomly assigned to either of two conditions. Those assigned to The Senior Connection (TSC) will either be paired with a peer companion or, if they prefer and are eligible, be trained and placed as a peer companion for others by RSVP. The comparison group will receive no further intervention ("care-as-usual" [CAU]). Subjects will be followed for up to 24 months with repeated in-home (baseline, 12, and 24 months) and telephone assessments (3, 6, and 18 months).
- Conditions
- Suicidal Ideation, Depression
- Being tested
- Peer Companionship
- Keywords
- Suicidal Ideation, Loneliness, Social Support, Voluntary Workers, Friends/Companions, Prevention, Aged
- Medical subject headings
- Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer CompanionshipBehavioural
Also called Intervention is administered to the peer companionship arm.
Peer companionship is provided at least four times per month over two years in the form of friendly visiting, supportive phone calls, and some instrumental support.
| Study group | Role | What they receive |
|---|---|---|
| Peer Companionship | Experimental | Behavioral intervention: Receipt of peer companionship provided by trained, supervised volunteer companions. Receives: Behavioral: Peer Companionship |
| Care-as-Usual | No intervention | Care-as-Usual in Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation
Severity of suicidal and death ideation assessed with the Geriatric Suicide Ideation Scale
Measured: Baseline, 3,6,12,18,24 months
Secondary outcomes (3)
Social Connectedness
Thwarted belongingness and perceived burdensomeness assessed by the Interpersonal Needs Questionnaire.
Measured: Baseline, 3,6,12,18,24 months
Connectedness
Social network size/density/quality assessed with the National Social Life, Health, and Aging Project Social Network Module.
Measured: Baseline, 3,6,12,18,24 months
Depression
Assessed with the PHQ-9
Measured: Baseline, 3,6,12,18,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Yeates Conwell, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408654
- Sponsor's protocol ID
- 1U01CE001942-01
- Acronym
- TSC
- Status last verified
- Apr 2016
- First submitted
- 1 Aug 2011
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Orden KA, Stone DM, Rowe J, McIntosh WL, Podgorski C, Conwell Y. The Senior Connection: design and rationale of a randomized trial of peer companionship to reduce suicide risk in later life. Contemp Clin Trials. 2013 May;35(1):117-26. doi: 10.1016/j.cct.2013.03.003. Epub 2013 Mar 16.
PubMed 23506973Parkhurst KA, Daks JS, Conwell Y, Podgorski CA, Van Orden KA. Social network subtypes among socially disconnected older adults at risk for suicide: A latent class analysis. Suicide Life Threat Behav. 2022 Oct;52(5):963-974. doi: 10.1111/sltb.12893. Epub 2022 Jun 23.
PubMed 35735167
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Connections and Healthy Aging (The Senior Connection)
- ClinicalTrials.gov ID
- NCT01408654
- Acronym / sponsor ID
- TSC / 1U01CE001942-01
- Conditions
- Suicidal Ideation, Depression
- Keywords
- Suicidal Ideation, Loneliness, Social Support, Voluntary Workers, Friends/Companions, Prevention, Aged
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Aug 2011 (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.
This randomized trial compares peer companionship to care-as-usual in primary care on the outcome of risk for suicidal behavior in late life. The investigators hypothesize that older adults assigned to receive peer companionship will report greater social connectedness and less death and suicidal ideation compared to older adults assigned to care as usual.
Detailed description
There is a pressing need for interventions that reduce risk for suicide in later life. Older adults in the U.S. have the highest rate of suicide and are the fastest growing segment of the population. The investigators can anticipate a large rise in the number of older adults who die by suicide in coming decades. This application is in response to RFA-CE-10-006. Consistent with the CDC's key strategy of reducing suicide by promoting connectedness, our long-term goal is to reduce late life suicide-related morbidity and mortality by leveraging the resources and expertise of the aging services provider network (ASPN) to address unmet social needs of community-dwelling older adults. Our objectives with this proposal are (1) to examine whether linking socially disconnected seniors with peer supports through the Retired and Senior Volunteer Program (RSVP) is effective in reducing risk for suicide, and (2) to test an hypothesized mechanism for the association of social disconnectedness and suicidal ideation and behavior informed by the Interpersonal Theory of Suicide.
The investigators will recruit 400 primary care patients (200 men and 200 women) over age 60 years who endorse feeling lonely and/or as if they are a burden on others. They will be randomly assigned to either of two conditions. Those assigned to The Senior Connection (TSC) will either be paired with a peer companion or, if they prefer and are eligible, be trained and placed as a peer companion for others by RSVP. The comparison group will receive no further intervention ("care-as-usual" [CAU]). Subjects will be followed for up to 24 months with repeated in-home (baseline, 12, and 24 months) and telephone assessments (3, 6, and 18 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Companionship | Experimental | Behavioral: Peer CompanionshipBehavioral intervention: Receipt of peer companionship provided by trained, supervised volunteer companions. |
| Care-as-Usual | No intervention | –Care-as-Usual in Primary Care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60 or older
- Primary Care Patient
- Endorses feeling lonely and/or like a burden in the the past two weeks
Key exclusion criteria (4 listed)
- Positive dementia screen
- Current alcohol abuse
- Psychosis
- Suicidal ideation with intent to act (current or past month.)
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 |
|---|---|---|
| Peer CompanionshipAlso: Intervention is administered to the peer companionship arm.Peer companionship is provided at least four times per month over two years in the form of friendly visiting, supportive phone calls, and some instrumental support. | Behavioural | Peer Companionship |
Primary outcome
Suicidal Ideation
Time frame: Baseline, 3,6,12,18,24 months
Severity of suicidal and death ideation assessed with the Geriatric Suicide Ideation Scale
3 secondary outcomes
Social Connectedness
Time frame: Baseline, 3,6,12,18,24 months
Connectedness
Time frame: Baseline, 3,6,12,18,24 months
Depression
Time frame: Baseline, 3,6,12,18,24 months
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 22 Apr 2016.
- Background: PubMed 23506973Van Orden KA, Stone DM, Rowe J, McIntosh WL, Podgorski C, Conwell Y. The Senior Connection: design and rationale of a randomized trial of peer companionship to reduce suicide risk in later life. Contemp Clin Trials. 2013 May;35(1):117-26. doi: 10.1016/j.cct.2013.03.003. Epub 2013 Mar 16.
- Derived from this study: PubMed 35735167Parkhurst KA, Daks JS, Conwell Y, Podgorski CA, Van Orden KA. Social network subtypes among socially disconnected older adults at risk for suicide: A latent class analysis. Suicide Life Threat Behav. 2022 Oct;52(5):963-974. doi: 10.1111/sltb.12893. Epub 2022 Jun 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peer Companionship in people with Suicidal Ideation and Depression, run by University of Rochester at 1 site in United States.
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 3 inclusion and 4 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 22 Apr 2016. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Suicidal Ideation (time frame: Baseline, 3,6,12,18,24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01408654, which also lists 2 linked publications.
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 22 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.