Trial Outcomes & Findings for Tele-Self CBTI Trial (NCT NCT03727438)

Last Updated: 2024-09-24

Results Overview

Insomnia Severity Index (ISI): The ISI is recommended as the standard for self-reported insomnia symptoms, and will be used as the primary outcome measure. The ISI is a 7-item questionnaire providing a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale and the total score ranges from 0 (no reported symptoms) to 28 (highest insomnia severity symptoms). The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (sub threshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). In clinical samples, a cut off score of 11 was shown to have the greatest sensitivity and specificity for correctly identifying study participants meeting criteria for insomnia diagnosis.

Recruitment status

COMPLETED

Study phase

Target enrollment

178 participants

Primary outcome timeframe

Baseline to 8 weeks

Results posted on

2024-09-24

Participant Flow

Participants were veterans recruited from the Durham VA Health Care System (HCS) catchment area between 10/4/2019 to 4/26/2022. A data pull from the electronic medical record (EMR), identified veterans who were seeking treatment for insomnia but not yet treated using CBT-I. A chart review of the electronic record was also performed. Potentially eligible patients were then mailed an invitation letter beginning on 9/20/19. They were then contacted, consented and screened over the phone.

Consented participants completed a 2 week assessment period before being randomized. Participants not completing at least 10 days of sleep diary and/or baseline questionnaires were excluded, even if they provided actigraphy data. 178 completed baseline, enrolled and randomized to either Tele-Self CBTI or Health Education Control (HEC), using a stratified, blocked randomization, by baseline Insomnia Severity Index score (≤20/\>20) and presence/absence of a pre-existing mental health diagnosis.

Participant milestones

Participant milestones
Measure	Tele-Self CBTI The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period.	Health Education Control The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 8 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Baseline STARTED	88	90
Baseline COMPLETED	88	90
Baseline NOT COMPLETED	0	0
Intervention Period STARTED	88	90
Intervention Period COMPLETED	77	88
Intervention Period NOT COMPLETED	11	2
8 Week Assessment STARTED	84	89
8 Week Assessment COMPLETED	70	83
8 Week Assessment NOT COMPLETED	14	6
6 mo Assessment STARTED	78	88
6 mo Assessment COMPLETED	68	77
6 mo Assessment NOT COMPLETED	10	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Tele-Self CBTI The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period.	Health Education Control The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 8 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Intervention Period Did not complete at least 3 calls but remained in study	7	1
Intervention Period Excluded (health)	1	0
Intervention Period Withdrawal by Subject	3	1
8 Week Assessment Did not complete assessment but remained in study	6	5
8 Week Assessment Did not complete due to study error, remained in study	2	0
8 Week Assessment Withdrawal by Subject	6	1
6 mo Assessment did not complete assessment	10	11

Baseline Characteristics

Tele-Self CBTI Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tele-Self CBTI n=88 Participants The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=90 Participants The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.	Total n=178 Participants Total of all reporting groups
Age, Continuous Age	55.1 years STANDARD_DEVIATION 13.2 • n=93 Participants	55.1 years STANDARD_DEVIATION 13.3 • n=4 Participants	55.1 years STANDARD_DEVIATION 13.2 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	24 Participants n=4 Participants	50 Participants n=27 Participants
Sex: Female, Male Male	62 Participants n=93 Participants	66 Participants n=4 Participants	128 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=93 Participants	86 Participants n=4 Participants	167 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	34 Participants n=93 Participants	42 Participants n=4 Participants	76 Participants n=27 Participants
Race (NIH/OMB) White	47 Participants n=93 Participants	40 Participants n=4 Participants	87 Participants n=27 Participants
Race (NIH/OMB) More than one race	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	88 Participants n=93 Participants	90 Participants n=4 Participants	178 Participants n=27 Participants
Baseline ISI >20 n (%)	17 Participants n=93 Participants	18 Participants n=4 Participants	35 Participants n=27 Participants
Mental health diagnosis n (%)	73 Participants n=93 Participants	74 Participants n=4 Participants	147 Participants n=27 Participants
Currently using sleep medications n	60 Participants n=93 Participants	60 Participants n=4 Participants	120 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.

Outcome measures

Outcome measures
Measure	Tele-Self CBTI n=88 Participants The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=90 Participants The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Insomnia Severity Baseline	16.1 ISI score Standard Error 0.2	16.1 ISI score Standard Error 0.2
Insomnia Severity 8 Weeks	10.4 ISI score Standard Error 0.5	14.1 ISI score Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline to 8 week

Population: This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.

Sleep Diary sleep onset latency, using the Consensus Sleep Diary (CSD), which is the amount of time asleep in bed divided by the amount of time in bed, averaged across days. The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data will then be averaged across each 2-week assessment period.

Outcome measures

Outcome measures
Measure	Tele-Self CBTI n=88 Participants The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=90 Participants The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Subjective Sleep Onset Latency (SOL) Baseline	49.4 minutes Standard Error 2.6	49.4 minutes Standard Error 2.6
Subjective Sleep Onset Latency (SOL) 8 week	26.5 minutes Standard Error 3.1	46.1 minutes Standard Error 2.9

SECONDARY outcome

Timeframe: Baseline to 8 week

Population: This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.

Sleep Diary WASO, using the Consensus Sleep Diary (CSD). The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data will then be averaged across each 2-week assessment period to determine SOL, WASO and SE.

Outcome measures

Outcome measures
Measure	Tele-Self CBTI n=88 Participants The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=90 Participants The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Subjective Wake After Sleep Onset (WASO) 8 week	33.5 minutes Standard Error 3.6	54.0 minutes Standard Error 3.3
Subjective Wake After Sleep Onset (WASO) Baseline	58.8 minutes Standard Error 3.1	58.8 minutes Standard Error 3.1

SECONDARY outcome

Timeframe: Baseline to 8 week

Population: This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.

Sleep Diary sleep efficiency, calculated from the Consensus Sleep Diary (CSD), which is the percent of the time asleep out of amount of time spent in bed. The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data are averaged across each 2-week assessment period.

Outcome measures

Outcome measures
Measure	Tele-Self CBTI n=88 Participants The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=90 Participants The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Subjective Sleep Efficiency (SE) Baseline	65.4 percentage of time in bed where asleep Standard Error 1.2	65.4 percentage of time in bed where asleep Standard Error 1.2
Subjective Sleep Efficiency (SE) 8 week	79.0 percentage of time in bed where asleep Standard Error 1.5	68.0 percentage of time in bed where asleep Standard Error 1.4

SECONDARY outcome

Timeframe: Baseline to 8 week

Population: To be included in actigraphy analyses, actigraphy data must have overlapped with sleep diary data (same dates) for a minimum of 7 nights. Estimated means were used. All available data, including observations from participants who dropped out of the study, were used for primary and secondary analyses. Model parameters included a common intercept (baseline means constrained to be equal), with the model examining estimated group differences.

Objective WASO using Wrist Actigraphy: The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. WASO is the total number of epochs between the start time and the end time of the given sleep interval scored as wake by Actiware software multiplied by the epoch length in minutes. The investigators will average data across each two-week assessment period. Not all participants completed actigraphy procedures

Outcome measures

Outcome measures
Measure	Tele-Self CBTI n=74 Participants The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=74 Participants The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Objective Wake After Sleep Onset Baseline	48.7 minutes Standard Error 1.8	48.7 minutes Standard Error 1.8
Objective Wake After Sleep Onset 8 week	48.7 minutes Standard Error 2.7	54.9 minutes Standard Error 2.6

SECONDARY outcome

Timeframe: Baseline to 8 week

Population: To be included in actigraphy analyses, actigraphy data must have overlapped with sleep diary data (same dates) for a minimum of 7 nights. Estimated means were used. This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.

Objective total sleep time using Wrist Actigraphy: The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. The investigators will average data across each two-week assessment period to determine actigraphy-based WASO, Total Sleep Time (TST) and SE. Not all participants completed actigraphy procedures

Outcome measures

Outcome measures
Measure	Tele-Self CBTI n=74 Participants The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=74 Participants The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Objective Total Sleep Time (TST) 8 week	6.2 minutes Standard Error 0.2	6.2 minutes Standard Error 0.2
Objective Total Sleep Time (TST) Baseline	5.9 minutes Standard Error 0.1	5.9 minutes Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline to 8 week

Objective SE using Wrist Actigraphy. The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. SE is the percentage of time spent in bed sleeping, scored total sleep time divided by (interval duration minus total invalid time (sleep/wake)) of the given rest interval multiplied by 100.The investigators will average data across each two-week assessment period.

Outcome measures

Outcome measures
Measure	Tele-Self CBTI n=74 Participants The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=74 Participants The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Objective Sleep Efficiency (SE) Baseline	86.3 percentage of time in bed where asleep Standard Error 0.4	86.3 percentage of time in bed where asleep Standard Error 0.4
Objective Sleep Efficiency (SE) 8 week	87.0 percentage of time in bed where asleep Standard Error 0.6	85.4 percentage of time in bed where asleep Standard Error 0.5

Adverse Events

Tele-Self CBTI

Serious events: 15 serious events

Other events: 31 other events

Deaths: 0 deaths

Health Education Control

Serious events: 16 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tele-Self CBTI n=88 participants at risk The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period.	Health Education Control n=90 participants at risk The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Blood and lymphatic system disorders Blood and lymphatic system disorders	1.1% 1/88 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	1.1% 1/90 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Cardiac disorders cardiac disorder	0.00% 0/88 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	1.1% 1/90 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Gastrointestinal disorders Gastrointestinal disorders	1.1% 1/88 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	0.00% 0/90 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Infections and infestations Infections and infestations	3.4% 3/88 • Number of events 3 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	1.1% 1/90 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	4.5% 4/88 • Number of events 4 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	1.1% 1/90 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	1.1% 1/88 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	1.1% 1/90 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Psychiatric disorders Psychiatric disorders	0.00% 0/88 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	2.2% 2/90 • Number of events 2 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Renal and urinary disorders renal	1.1% 1/88 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	0.00% 0/90 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.00% 0/88 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	2.2% 2/90 • Number of events 2 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Surgical and medical procedures Surgical and medical procedures	4.5% 4/88 • Number of events 4 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	6.7% 6/90 • Number of events 6 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.
Vascular disorders Vascular disorders	0.00% 0/88 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.	1.1% 1/90 • Number of events 1 • from randomization to 6 month assessment, approximately 6 months. Participants were queried at Baseline, 8 weeks and 6 months.

Other adverse events

Additional Information

Jennifer Zervakis

Department of Veteran Affairs ADAPT

Phone: 919 286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place