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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH137185 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| University of California, Berkeley | OTHER |
| University of California, Los Angeles | OTHER |
| Augusta University |
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This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality.
Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.
The main purpose of the study is to compare the effects of two approaches on sleep and mood including any symptoms of depression and suicidality. There will be 420 people invited to participate across three sites in the United States (University of Pittsburgh, UCLA, Augusta).
Participants will be randomized to receive one of two evidence-based programs that are designed to help improve outcomes. Each group will contain 210 participants. Researchers will enroll a total of 140 participants (70 in each group) at the University of Pittsburgh. Both groups will meet with a study therapist once a week to complete the assigned 8-week program. To determine which (if any) program has beneficial effect over time, researchers will ask participants to complete assessments of their sleep, mood, and health before and after the therapy. Certain information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
There are three main study visits where participants will complete assessments about their sleep, mood, cognition and health. These would be:
Around the time of each visit, researchers will ask participants to wear an actigraphy watch on their wrist 24/7 for a week while completing a sleep diary. The actigraphy watch is a wrist-watch like device that measures movement so that researchers can estimate the participant's activity and sleep levels.
After the first main visit is complete, participants will be randomly assigned to one of two programs that include meeting with a study clinician for 30-50 minutes each week for 8 weeks (8 sessions total). Both groups will receive educational information and, depending on the group the participants are assigned to, may include guided discussions, activities, and/or support addressing any stressors participants face, sleep problems, and/or depression.
During the therapy period, researchers would ask participants to continue wearing the actigraphy watch. Researchers would also ask participants to answer questions on the phone with study staff every other week, starting at week 2 (that would take about 30-40 minutes a week).
After the participant's last therapy session, researchers would repeat the phone assessments once a month until the last main visit occurs (six-months after therapy ends). Participants will have one more call at about 6 months after the last main visit (12 months after the therapy ended) to repeat some phone assessments done during the bi-weekly and monthly calls).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concealed Control Intervention | Active Comparator | Participants receive eight ~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design. |
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| Active Condition | Experimental | Participants receive eight ~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment As Usual | Other | In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors. |
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| Measure | Description | Time Frame |
|---|---|---|
| Depression Symptom Response | The outcome is the rate of clinically significant depression symptom responses six-months post treatment, defined as having ≥50% reduction in pre-treatment depression severity six-months posttreatment. Depression severity will be assessed as total scores from the 14 non-sleep items of the clinician rated GRID Hamilton Depression Rating Scale. Lower scores on the GRID Hamilton would indicate a reduction in depression symptoms. | six months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Suicide Ideation Severity | Measuring rates of clinically significant past-month active SI at the six-month follow-up defined as Columbia Suicide Severity Rating Scale (CSSR) ideation dimension scores ≥ 3. This level on the CSSR, equivalent to having at least SI with a method, was identified as an optimal cut-off for predicting future suicide death. Lower scores on the Columbia Suicide Severity Rating Scale would indicate lower levels of suicide ideation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Sellars, M.A | Contact | 412-246-5963 | alberts3@upmc.edu | |
| Stephen Smagula, Ph.D | Contact | 412-246-6674 | smagulasf@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen F Smagula, Ph.D | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Regents of the University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
Individual participant data that underlie the main measures of this study as reported in publications after de-identification.
Beginning 6 months and ending 5 years after article publication
Researchers who provide methodologically sound proposal
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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| Active Condition | Behavioral | Participants receive eight ~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design. |
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| Active Comparator | Behavioral | Participants receive eight ~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design. |
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| from Enrollment to the end of treatment at 6-months post-intervention |
| Suicide Behavior Outcomes | Any suicidal behaviors over the six-month follow-up defined as escalating planning, suicide attempt, or suicide-related hospitalization. | from Enrollment to the end of treatment at 6-months post-intervention |
| Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
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| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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