RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts
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|ClinicalTrials.gov Identifier: NCT03603717|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Suicidal Ideation||Behavioral: Cognitive Behavioral Therapy for Insomnia Behavioral: Sleep Hygiene||Not Applicable|
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 HSR&D 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two parallel study arms: (1) cognitive behavioral therapy for insomnia (the experimental condition) and (2) sleep hygiene (the control condition).|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Improving Sleep as a Strategy to Reduce Suicide Risk Among At-Risk Veterans: A Real World Clinical Trial|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
Behavioral: 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.
Active Comparator: SH
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.
Behavioral: 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.
- Insomnia Severity Index Change [ Time Frame: Baseline (Week 0) and 6 Month follow-up (Week 30) ]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.
- Scale for Suicidal ideation Change [ Time Frame: Baseline (Week 0) and 6 Month follow-up (Week 30) ]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.
- PTSD Symptom Checklist-DSM 5 Change [ Time Frame: Baseline (Week 0) and 6 Month follow-up (Week 30) ]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.
- Patient Health Questionnaire-Depression Change [ Time Frame: Baseline (Week 0) and 6 Month follow-up (Week 30) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603717
|Contact: Wilfred R Pigeon, PhD||(585) 393-7918||Wilfred.Pigeon2@va.gov|
|Contact: Jennifer S Funderburk, PhD||(315) 425-4400 ext 54703||Jennifer.Funderburk@va.gov|
|United States, New York|
|VA Western New York Healthcare System, Buffalo, NY||Not yet recruiting|
|Buffalo, New York, United States, 14215|
|Contact: Laura Wray, PhD 716-862-8598 firstname.lastname@example.org|
|Contact: Jennifer Funderburk, PhD 5853932525 email@example.com|
|Canandaigua VA Medical Center, Canandaigua, NY||Not yet recruiting|
|Canandaigua, New York, United States, 14424|
|Contact: Wilfred R Pigeon, PhD 585-393-7918 Wilfred.Pigeon2@va.gov|
|Principal Investigator: Wilfred R. Pigeon, PhD|
|Syracuse VA Medical Center, Syracuse, NY||Recruiting|
|Syracuse, New York, United States, 13210|
|Contact: Jennifer Funderburk, PhD 585-393-2525 firstname.lastname@example.org|
|Contact: Wilfred R Pigeon, PhD 5853937918 email@example.com|
|Principal Investigator:||Wilfred R. Pigeon, PhD||Canandaigua VA Medical Center, Canandaigua, NY|