Trial Outcomes & Findings for Telemedicine Management of Chronic Insomnia (NCT NCT01686438)

NCT ID: NCT01686438

Last Updated: 2019-08-29

Results Overview

Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 114 participants
• Primary outcome timeframe: Baseline to 3 months
• Results posted on: 2019-08-29

Participant Flow

114 participants were consented and randomized in the study. 87 of those participants started in treatment in this study. Of those, 57 completed treatment sessions. 55 of the 57 who completed treatment are included in the analysis of this study.

Participant milestones

Measure	Control Non-active intervention of sleep education delivered in-person	CBT-I In-person Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Study STARTED	15	35	37
Overall Study 2-Week Follow Up	12	31	27
Overall Study 3-Month Follow Up	7	21	17
Overall Study 6-Month Follow Up	7	26	24
Overall Study COMPLETED	7	26	24
Overall Study NOT COMPLETED	8	9	13

Reasons for withdrawal

Measure	Control Non-active intervention of sleep education delivered in-person	CBT-I In-person Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Study Lost to Follow-up	8	9	10
Overall Study Adverse Event	0	0	1
Overall Study Protocol Violation	0	0	1
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Telemedicine Management of Chronic Insomnia

Baseline characteristics by cohort

Measure	Control n=7 Participants Non-active intervention of sleep education delivered in-person	CBT-I In-person n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	Total n=55 Participants Total of all reporting groups
Age, Continuous	60.57 years STANDARD_DEVIATION 10.05 • n=5 Participants	56.16 years STANDARD_DEVIATION 10.84 • n=7 Participants	56.57 years STANDARD_DEVIATION 11.24 • n=5 Participants	56.89 years STANDARD_DEVIATION 10.82 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	49 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Unavailable (do not wish to provide information)	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Body Mass Index (BMI)	32.05 kg/m^2 STANDARD_DEVIATION 2.79 • n=5 Participants	34.02 kg/m^2 STANDARD_DEVIATION 6.77 • n=7 Participants	34.31 kg/m^2 STANDARD_DEVIATION 4.97 • n=5 Participants	33.89 kg/m^2 STANDARD_DEVIATION 5.64 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations). This analysis was intended to only compare the two CBT-I groups for non-inferiority analysis.

Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.

Outcome measures

Measure	CBT-I In-person n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline in Insomnia Severity Index Score	6.68 units on a scale Standard Deviation 1.09	5.13 units on a scale Standard Deviation 1.15	—

SECONDARY outcome

Timeframe: baseline to 3 months

Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations

Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline PTSD Checklist-Military (PCL-M) Scores	3.30 units on a scale Standard Error 3.33	5.73 units on a scale Standard Error 1.87	5.22 units on a scale Standard Error 1.96

SECONDARY outcome

Timeframe: baseline to 3 months

Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score < 5 is associated with good sleep quality.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores	2.03 units on a scale Standard Error 1.36	3.34 units on a scale Standard Error 0.71	2.50 units on a scale Standard Error 0.76

SECONDARY outcome

Timeframe: baseline to 3 months

Population: Patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)	0.30 units on a scale Standard Error 1.13	0.23 units on a scale Standard Error 0.66	0.51 units on a scale Standard Error 0.71

SECONDARY outcome

Timeframe: baseline to 3 month

Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline in Nightmare Distress Questionnaire Scores	-3.78 units on a scale Standard Error 1.67	-2.65 units on a scale Standard Error 0.98	-0.11 units on a scale Standard Error 1.07

SECONDARY outcome

Timeframe: baseline to 3 months

Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score	0.26 units on a scale Standard Error 2.79	0.70 units on a scale Standard Error 1.55	2.76 units on a scale Standard Error 1.65

SECONDARY outcome

Timeframe: baseline to 3 months

Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score	3.31 units on a scale Standard Error 2.24	-1.37 units on a scale Standard Error 1.22	0.14 units on a scale Standard Error 1.31

SECONDARY outcome

Timeframe: baseline to 3 months

Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline in Work and Social Adjustment Scale Scores	-0.54 units on a scale Standard Error 2.77	0.01 units on a scale Standard Error 1.46	-0.85 units on a scale Standard Error 1.63

SECONDARY outcome

Timeframe: 2-8 weeks

Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks	62.5 score on a scale Standard Deviation 6.24	76.8 score on a scale Standard Deviation 5.02	74.1 score on a scale Standard Deviation 8.64

SECONDARY outcome

Timeframe: 2-8 weeks

Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks	47.5 score on a scale Standard Deviation 6.54	46.7 score on a scale Standard Deviation 9.09	44.8 score on a scale Standard Deviation 12.16

SECONDARY outcome

Timeframe: baseline to 3 months, scores converted to yearly

Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.

Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores	-26.1 nights per year Standard Error 20.13	11.35 nights per year Standard Error 11.39	-3.04 nights per year Standard Error 12.65

SECONDARY outcome

Timeframe: baseline to 3 months (converted to yearly)

Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.

Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores	-24.6 number of nightmares Standard Error 23.87	6.41 number of nightmares Standard Error 13.48	-8.09 number of nightmares Standard Error 15.27

SECONDARY outcome

Timeframe: 2-8 weeks

Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks	72.8 score on a scale Standard Deviation 11.15	77.4 score on a scale Standard Deviation 7.57	76.8 score on a scale Standard Deviation 8.41

SECONDARY outcome

Timeframe: 2-8 weeks

Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)

The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.

Outcome measures

Measure	CBT-I In-person n=7 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=25 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing	CBT-I Telehealth n=23 Participants Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks	67.5 score on a scale Standard Deviation 10.15	75.8 score on a scale Standard Deviation 7.54	75.3 score on a scale Standard Deviation 10.28

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CBT-I In-person

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

CBT-I Telehealth

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=15 participants at risk Non-active intervention of sleep education delivered in-person	CBT-I In-person n=35 participants at risk Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=37 participants at risk Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Psychiatric disorders hospitalized for suicide ideation	0.00% 0/15 • Duration of study, an average of 2.5 years	0.00% 0/35 • Duration of study, an average of 2.5 years	2.7% 1/37 • Number of events 1 • Duration of study, an average of 2.5 years

Other adverse events

Measure	Control n=15 participants at risk Non-active intervention of sleep education delivered in-person	CBT-I In-person n=35 participants at risk Cognitive behavior therapy for insomnia (CBT-I) delivered in-person	CBT-I Telehealth n=37 participants at risk Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Surgical and medical procedures Tonsillectomy	0.00% 0/15 • Duration of study, an average of 2.5 years	2.9% 1/35 • Number of events 1 • Duration of study, an average of 2.5 years	0.00% 0/37 • Duration of study, an average of 2.5 years
Musculoskeletal and connective tissue disorders Gout	0.00% 0/15 • Duration of study, an average of 2.5 years	2.9% 1/35 • Number of events 1 • Duration of study, an average of 2.5 years	0.00% 0/37 • Duration of study, an average of 2.5 years

Additional Information

Dr. Samuel T. Kuna

Crescenz VA Medical Center

Phone: 215-823-4400

Email: Samuel.Kuna@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place