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RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts

Improving Sleep as a Strategy to Reduce Suicide Risk Among At-Risk Veterans: A Real World Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03603717
Enrollment
283
Registered
2018-07-27
Start date
2019-02-18
Completion date
2023-06-30
Last updated
2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Suicidal Ideation

Keywords

insomnia, suicidal ideation, depression, posttraumatic stress disorder, cognitive behavioral therapy for insomnia, sleep, suicide

Brief 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.

Detailed 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.

Interventions

BEHAVIORALCognitive 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.

BEHAVIORALSleep 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.

Intervention model description

Two parallel study arms: (1) cognitive behavioral therapy for insomnia (the experimental condition) and (2) sleep hygiene (the control condition).

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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: * \[a\] a current diagnosis of Major Depressive Disorder, Depression not otherwise specified or PTSD * \[b\] a score of \> 16 on the Patient Health Questionnaire for Depression (PHQ-9) or a score \> 46 on the PTSD Symptom Checklist * 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 * Sleep medications are not exclusionary, but participants using them must still meet insomnia criteria

Design outcomes

Primary

MeasureTime frameDescription
Insomnia Severity Index ChangeBaseline (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.

Secondary

MeasureTime frameDescription
Scale for Suicidal Ideation ChangeBaseline (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 ChangeBaseline (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 ChangeBaseline (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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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 by arm

ArmCount
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.
98
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.
96
Total194

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up2020
Overall StudyWithdrawal by Subject1610

Baseline characteristics

CharacteristicSleep HygieneTotalCBT-I
Age, Continuous51.51 years
STANDARD_DEVIATION 12.83
51.50 years
STANDARD_DEVIATION 13.69
51.49 years
STANDARD_DEVIATION 14.5
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants18 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
84 Participants175 Participants91 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Insomnia Severity Index Change18.58 units on a scale
STANDARD_DEVIATION 4.1
19.06 units on a scale
STANDARD_DEVIATION 4.14
19.52 units on a scale
STANDARD_DEVIATION 4.14
Patient Health Questionnaire-Depression Change14.47 units on a scale
STANDARD_DEVIATION 5.24
15.18 units on a scale
STANDARD_DEVIATION 5.12
15.88 units on a scale
STANDARD_DEVIATION 4.93
PTSD Symptom Checklist-DSM 5 Change41.53 units on a scale
STANDARD_DEVIATION 14.97
43.43 units on a scale
STANDARD_DEVIATION 14.32
45.29 units on a scale
STANDARD_DEVIATION 13.48
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
9 Participants14 Participants5 Participants
Race (NIH/OMB)
More than one race
8 Participants15 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
79 Participants160 Participants81 Participants
Region of Enrollment
United States
96 Participants194 Participants98 Participants
Scale for Suicidal Ideation Change3.88 units on a scale
STANDARD_DEVIATION 5.86
3.54 units on a scale
STANDARD_DEVIATION 5.32
3.21 units on a scale
STANDARD_DEVIATION 4.73
Sex: Female, Male
Female
24 Participants45 Participants21 Participants
Sex: Female, Male
Male
72 Participants149 Participants77 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 980 / 96
other
Total, other adverse events
2 / 980 / 96
serious
Total, serious adverse events
3 / 984 / 96

Outcome results

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.

Time frame: Baseline (Week 0) and 6 Month follow-up (Week 30)

Population: All participants who were assigned to the arm.

ArmMeasureValue (MEAN)Dispersion
CBT-IInsomnia Severity Index Change8.54 score on a scaleStandard Deviation 6.03
Sleep HygieneInsomnia Severity Index Change11.88 score on a scaleStandard Deviation 6.36
p-value: <0.01Mixed Models Analysis
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.

Time frame: Baseline (Week 0) and 6 Month follow-up (Week 30)

Population: All participants who were assigned to study arm.

ArmMeasureValue (MEAN)Dispersion
CBT-IPatient Health Questionnaire-Depression Change8.92 score on a scaleStandard Deviation 6.03
Sleep HygienePatient Health Questionnaire-Depression Change11.33 score on a scaleStandard Deviation 6.48
p-value: 0.01Mixed Models Analysis
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.

Time frame: Baseline (Week 0) and 6 Month follow-up (Week 30)

Population: All participants who were assigned to study arm.

ArmMeasureValue (MEAN)Dispersion
CBT-IPTSD Symptom Checklist-DSM 5 Change29.68 score on a scaleStandard Deviation 18.02
Sleep HygienePTSD Symptom Checklist-DSM 5 Change29.94 score on a scaleStandard Deviation 17.62
p-value: 0.84Mixed Models Analysis
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.

Time frame: Baseline (Week 0) and 6 Month follow-up (Week 30)

Population: All participants who were assigned to study arm.

ArmMeasureValue (MEAN)Dispersion
CBT-IScale for Suicidal Ideation Change1.08 score on a scaleStandard Deviation 2.08
Sleep HygieneScale for Suicidal Ideation Change3.10 score on a scaleStandard Deviation 5.12
p-value: 0.03Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026