Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03603717 |
| Other study ID # |
IIR 16-055 |
| Secondary ID |
I01HX002183-01A2 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 18, 2019 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
