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| ID | Type | Description | Link |
|---|---|---|---|
| I01HX002183-01A2 | U.S. NIH Grant/Contract | View source |
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There is a strong association between insomnia and suicidal thoughts and behaviors. Insomnia also frequently co-occurs with other common conditions associated with suicide such as depression and posttraumatic stress disorder. This project focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a broad range of Veterans. The study will examine how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal thoughts in Veterans who also suffer from co-occurring conditions when delivered by integrated primary care clinicians.
Anticipated Benefit to VA Healthcare The proposed study will establish the feasibility and effectiveness of treating insomnia in the primary care environment as a suicide prevention strategy. By treating insomnia, a common problem that is both a risk factor for suicide and highly prevalent in common conditions associated with suicide such as depression and posttraumatic stress disorder (PTSD), the investigators expect to reduce the severity of suicidal ideation (SI) among Veterans experiencing SI, insomnia and a co-occurring condition.
Project Background Suicide is the tenth leading cause of death in the U.S., is a major concern of the Department of Veterans Affairs (VA) and occurs at elevated rates among Veterans. Veterans with common chronic conditions such as PTSD and depression are at increased risk for suicide. Although evidence-based treatments exist for these conditions, a significant number of Veterans do not engage in or complete such treatments leaving them at higher risk for suicide.
This application builds upon VA funded pilot work that demonstrated the feasibility of delivering a brief version of cognitive-behavioral therapy for insomnia (CBT-I) within primary care to Veterans experiencing SI. The pilot data suggest that the investigators' brief, primary-care based insomnia treatment was delivered with high fidelity, acceptable to Veterans and associated with significant reductions in insomnia and depression symptoms, and reduced SI intensity. The next stage of this program of research is to establish the feasibility of delivering the brief, primary care based, insomnia intervention utilizing primary care-mental health integration (PC-MHI) clinicians (as opposed to research staff) and to establish the effectiveness of the intervention on reducing the severity of factors that contribute to suicide risk and to improve other clinical markers in a definitive trial.
Project Objectives The ultimate goal of the broader program of research is to reduce suicide among Veterans by intervening upon sleep disturbance as a modifiable risk factor for suicide. In this application the investigators focus on insomnia, which is the most common sleep disorder among Veterans and is robustly associated with suicidal thoughts and behaviors.
The primary objective of this proposed clinical trial is to test whether (and how) using brief behavioral insomnia treatment can not only improve sleep, but reduce other risk factors for suicide including the severity of depression, PTSD and suicidal ideation among Veterans at risk for suicide. Secondary objectives are to: (1) gather initial data on barriers and facilitators to implementation to aid future implementation efforts in VA primary care and (2) determine if the intervention improves attitudes towards psychotherapy treatments that address the co-morbid conditions.
Project Methods In order to achieve these objectives the investigators will conduct a real-world, randomized clinical trial among 240 Veterans experiencing either co-occurring depression or PTSD recruited from primary clinics at three VA sites. These Veterans, who will also endorse SI and insomnia, will be randomized to receive either a brief course of CBT-I or a sleep hygiene intervention of similar length. Assessments of suicidal thoughts and behaviors, insomnia, depression, and PTSD will be conducted at baseline, post-treatment, and every 6 weeks thereafter until 6 months post-treatment. Mixed effects modeling and structured equation modeling will be applied to determine how improvements in sleep and other symptoms (e.g. depression, PTSD) contribute to reductions in SI severity. In addition, the investigators will collect, code and analyze participant and provider feedback to assess barriers and facilitators of implementation in real-world clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Experimental | Four individual sessions that will last approximately 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. |
|
| Sleep Hygiene | Active Comparator | Four individual sessions that will last 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | The intervention will consist of a standard, structured, multi-component intervention for insomnia that includes sleep education, sleep hygiene, sleep restriction, stimulus control, and cognitive therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index Change | The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia symptoms. Each item is rated on a 0-4-point scale with a total score range of 0-28 where higher scores indicate greater severity. | Baseline (Week 0) and 6 Month follow-up (Week 30) |
| Measure | Description | Time Frame |
|---|---|---|
| Scale for Suicidal Ideation Change | The Scale for Suicidal Ideation is a clinician administered scale with 19-items related to suicidal ideation. Each item is rated on a 0-2 point scale with a total score range of 0-38 where higher scores indicate greater severity. | Baseline (Week 0) and 6 Month follow-up (Week 30) |
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Inclusion Criteria:
English speaking
Veteran seeking or receiving services at the Canandaigua, Buffalo or Syracuse VA Medical Centers
Demonstrate understanding of informed consent
Endorse current death/suicidal ideation on item 9 of the Patient Health Questionnaire-9
An Insomnia Severity Index score > 10 with trouble sleeping 3 months and at least 1 insomnia-related daytime consequence
Either:
If using psychotropic medications the dosage must be stable
Exclusion Criteria:
History of serious mental illness such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis, mania, dementia or cognitive impairment
A suicide attempt within the last 6 months or [report of SI with active plan or intent in the past month]
Currently engaged in inpatient or partial hospitalization programs
Recent substance dependence disorder with < 6 months abstinence
Narcolepsy
Circadian rhythm disorders
Restless legs syndrome
Untreated sleep apnea based upon chart review
A sleep disorders screening questionnaire and the STOP-BANG sleep apnea questionnaire
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| Name | Affiliation | Role |
|---|---|---|
| Wilfred R. Pigeon, PhD | VA Finger Lakes Healthcare System, Canandaigua, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | 14215-1129 | United States | ||
| VA Finger Lakes Healthcare System, Canandaigua, NY |
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A total of 283 participants were enrolled in the study and completed the baseline assessment. Of these, 83 did not meet eligibility criteria and 6 eligible participants withdrew prior to randomization. As a result, 194 participants were randomized.
Participants were recruited by a letter from their primary care physician from three Department of Veterans Affairs Medical Centers and then screened by telephone by study staff between January 2019 and November 2022. The first participant was enrolled on February 8, 2019 and the last participant enrolled in November 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT-I | Four individual sessions that will last approximately 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. Cognitive Behavioral Therapy for Insomnia: The intervention will consist of a standard, structured, multi-component intervention for insomnia that includes sleep education, sleep hygiene, sleep restriction, stimulus control, and cognitive therapy. |
| FG001 | Sleep Hygiene | Four individual sessions that will last 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. Sleep Hygiene: The intervention will include basic psychoeducation about sleep, discussion of sleep hygiene factors that disrupt and improve sleep, setting sleep hygiene goals, and developing action steps to achieve those goals. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT-I | Four individual sessions that will last approximately 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. Cognitive Behavioral Therapy for Insomnia: The intervention will consist of a standard, structured, multi-component intervention for insomnia that includes sleep education, sleep hygiene, sleep restriction, stimulus control, and cognitive therapy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Severity Index Change | The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia symptoms. Each item is rated on a 0-4-point scale with a total score range of 0-28 where higher scores indicate greater severity. | All participants who were assigned to the arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0) and 6 Month follow-up (Week 30) |
|
30 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT-I | Four individual sessions that will last approximately 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. Cognitive Behavioral Therapy for Insomnia: The intervention will consist of a standard, structured, multi-component intervention for insomnia that includes sleep education, sleep hygiene, sleep restriction, stimulus control, and cognitive therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency room visit for migraine headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wilfred Pigeon, PhD | Department of Veterans Affairs, Center of Excellence for Suicide Prevention | (585) 393-7918 | wilfred.pigeon2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2022 | Dec 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D059020 | Suicidal Ideation |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Two parallel study arms: (1) cognitive behavioral therapy for insomnia (the experimental condition) and (2) sleep hygiene (the control condition).
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Participants will be informed that they are receiving one of two non-medication sleep interventions. Assessors are blinded to study condition. Study staff entering data will be blinded to condition. It is not possible to blind staff delivering the interventions. The PI's are providing some supervision of the interventionists, so they will be unblinded for those participants they supervise interventionists on.
| Sleep Hygiene | Behavioral | The intervention will include basic psychoeducation about sleep, discussion of sleep hygiene factors that disrupt and improve sleep, setting sleep hygiene goals, and developing action steps to achieve those goals. |
|
| PTSD Symptom Checklist-DSM 5 Change |
The PTSD Symptom Checklist-DSM 5 version is a 20-item self-report measure of PTSD symptoms. Each item is rated on a 0-4 point scale with a total score range of 0-80 where higher scores indicate greater severity. |
| Baseline (Week 0) and 6 Month follow-up (Week 30) |
| Patient Health Questionnaire-Depression Change | The Patient Health Questionnaire-Depression is a 9-item self-report measure of depression symptoms. Each item is rated on a 0-3 point scale with a total score range of 0-27 where higher scores indicate greater severity. | Baseline (Week 0) and 6 Month follow-up (Week 30) |
| Canandaigua |
| New York |
| 14424-1159 |
| United States |
| Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York | 13210-2716 | United States |
| BG001 | Sleep Hygiene | Four individual sessions that will last 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. Sleep Hygiene: The intervention will include basic psychoeducation about sleep, discussion of sleep hygiene factors that disrupt and improve sleep, setting sleep hygiene goals, and developing action steps to achieve those goals. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insomnia Severity Index Change | Rated on a 0-4-point scale with a total score range of 0-28 where higher scores indicate greater severity | Mean | Standard Deviation | units on a scale |
|
| Scale for Suicidal Ideation Change | Rated on a 0-2 point scale with a total score range of 0-38 where higher scores indicate greater severity | Mean | Standard Deviation | units on a scale |
|
| PTSD Symptom Checklist-DSM 5 Change | Rated on a 0-4 point scale with a total score range of 0-80 where higher scores indicate greater severity | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire-Depression Change | Rated on a 0-3 point scale with a total score range of 0-27 where higher scores indicate greater severity | Mean | Standard Deviation | units on a scale |
|
| OG001 | Sleep Hygiene | Four individual sessions that will last 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. Sleep Hygiene: The intervention will include basic psychoeducation about sleep, discussion of sleep hygiene factors that disrupt and improve sleep, setting sleep hygiene goals, and developing action steps to achieve those goals. |
|
|
|
| Secondary | Scale for Suicidal Ideation Change | The Scale for Suicidal Ideation is a clinician administered scale with 19-items related to suicidal ideation. Each item is rated on a 0-2 point scale with a total score range of 0-38 where higher scores indicate greater severity. | All participants who were assigned to study arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0) and 6 Month follow-up (Week 30) |
|
|
|
|
| Secondary | PTSD Symptom Checklist-DSM 5 Change | The PTSD Symptom Checklist-DSM 5 version is a 20-item self-report measure of PTSD symptoms. Each item is rated on a 0-4 point scale with a total score range of 0-80 where higher scores indicate greater severity. | All participants who were assigned to study arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0) and 6 Month follow-up (Week 30) |
|
|
|
|
| Secondary | Patient Health Questionnaire-Depression Change | The Patient Health Questionnaire-Depression is a 9-item self-report measure of depression symptoms. Each item is rated on a 0-3 point scale with a total score range of 0-27 where higher scores indicate greater severity. | All participants who were assigned to study arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0) and 6 Month follow-up (Week 30) |
|
|
|
|
| 0 |
| 98 |
| 3 |
| 98 |
| 2 |
| 98 |
| EG001 | Sleep Hygiene | Four individual sessions that will last 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary. Sleep Hygiene: The intervention will include basic psychoeducation about sleep, discussion of sleep hygiene factors that disrupt and improve sleep, setting sleep hygiene goals, and developing action steps to achieve those goals. | 0 | 96 | 4 | 96 | 0 | 96 |
| Hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Suicide attempt (overdose) |
|
| hospitalization | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D001523 |
| Mental Disorders |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |