Trial Outcomes & Findings for RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts (NCT NCT03603717)
NCT ID: NCT03603717
Last Updated: 2024-06-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
283 participants
Primary outcome timeframe
Baseline (Week 0) and 6 Month follow-up (Week 30)
Results posted on
2024-06-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
96
|
|
Overall Study
COMPLETED
|
62
|
66
|
|
Overall Study
NOT COMPLETED
|
36
|
30
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
20
|
|
Overall Study
Withdrawal by Subject
|
16
|
10
|
Baseline Characteristics
RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts
Baseline characteristics by cohort
| Measure |
CBT-I
n=98 Participants
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.
|
Sleep Hygiene
n=96 Participants
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.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.49 years
STANDARD_DEVIATION 14.50 • n=5 Participants
|
51.51 years
STANDARD_DEVIATION 12.83 • n=7 Participants
|
51.50 years
STANDARD_DEVIATION 13.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Insomnia Severity Index Change
|
19.52 units on a scale
STANDARD_DEVIATION 4.14 • n=5 Participants
|
18.58 units on a scale
STANDARD_DEVIATION 4.10 • n=7 Participants
|
19.06 units on a scale
STANDARD_DEVIATION 4.14 • n=5 Participants
|
|
Scale for Suicidal Ideation Change
|
3.21 units on a scale
STANDARD_DEVIATION 4.73 • n=5 Participants
|
3.88 units on a scale
STANDARD_DEVIATION 5.86 • n=7 Participants
|
3.54 units on a scale
STANDARD_DEVIATION 5.32 • n=5 Participants
|
|
PTSD Symptom Checklist-DSM 5 Change
|
45.29 units on a scale
STANDARD_DEVIATION 13.48 • n=5 Participants
|
41.53 units on a scale
STANDARD_DEVIATION 14.97 • n=7 Participants
|
43.43 units on a scale
STANDARD_DEVIATION 14.32 • n=5 Participants
|
|
Patient Health Questionnaire-Depression Change
|
15.88 units on a scale
STANDARD_DEVIATION 4.93 • n=5 Participants
|
14.47 units on a scale
STANDARD_DEVIATION 5.24 • n=7 Participants
|
15.18 units on a scale
STANDARD_DEVIATION 5.12 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and 6 Month follow-up (Week 30)Population: All participants who were assigned to the arm.
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.
Outcome measures
| Measure |
CBT-I
n=98 Participants
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.
|
Sleep Hygiene
n=96 Participants
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.
|
|---|---|---|
|
Insomnia Severity Index Change
|
8.54 score on a scale
Standard Deviation 6.03
|
11.88 score on a scale
Standard Deviation 6.36
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 6 Month follow-up (Week 30)Population: All participants who were assigned to study arm.
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.
Outcome measures
| Measure |
CBT-I
n=98 Participants
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.
|
Sleep Hygiene
n=96 Participants
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.
|
|---|---|---|
|
Scale for Suicidal Ideation Change
|
1.08 score on a scale
Standard Deviation 2.08
|
3.10 score on a scale
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 6 Month follow-up (Week 30)Population: All participants who were assigned to study arm.
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.
Outcome measures
| Measure |
CBT-I
n=98 Participants
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.
|
Sleep Hygiene
n=96 Participants
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.
|
|---|---|---|
|
PTSD Symptom Checklist-DSM 5 Change
|
29.68 score on a scale
Standard Deviation 18.02
|
29.94 score on a scale
Standard Deviation 17.62
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 6 Month follow-up (Week 30)Population: All participants who were assigned to study arm.
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.
Outcome measures
| Measure |
CBT-I
n=98 Participants
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.
|
Sleep Hygiene
n=96 Participants
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.
|
|---|---|---|
|
Patient Health Questionnaire-Depression Change
|
8.92 score on a scale
Standard Deviation 6.03
|
11.33 score on a scale
Standard Deviation 6.48
|
Adverse Events
CBT-I
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Sleep Hygiene
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CBT-I
n=98 participants at risk
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.
|
Sleep Hygiene
n=96 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
1.0%
1/98 • Number of events 1 • 30 weeks
|
2.1%
2/96 • Number of events 2 • 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
0.00%
0/98 • 30 weeks
|
1.0%
1/96 • Number of events 1 • 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
1.0%
1/98 • Number of events 1 • 30 weeks
|
0.00%
0/96 • 30 weeks
|
|
Psychiatric disorders
Hospitalization
|
1.0%
1/98 • Number of events 1 • 30 weeks
|
0.00%
0/96 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
hospitalization
|
0.00%
0/98 • 30 weeks
|
1.0%
1/96 • Number of events 1 • 30 weeks
|
Other adverse events
| Measure |
CBT-I
n=98 participants at risk
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.
|
Sleep Hygiene
n=96 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Emergency room visit for migraine headache
|
2.0%
2/98 • Number of events 2 • 30 weeks
|
0.00%
0/96 • 30 weeks
|
Additional Information
Wilfred Pigeon, PhD
Department of Veterans Affairs, Center of Excellence for Suicide Prevention
Phone: (585) 393-7918
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place