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Telemedicine Management of Chronic Insomnia (VIP)

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ClinicalTrials.gov Identifier: NCT01686438
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sleep Initiation and Maintenance Disorders
Post-Traumatic Stress Disorders
Intervention Behavioral: Cognitive behavioral therapy for insomnia
Enrollment 114
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description Non-active intervention of sleep education delivered in-person Cognitive behavior therapy for insomnia (CBT-I) delivered in-person Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Period Title: Overall Study
Started 15 35 37
2-Week Follow Up 12 31 27
3-Month Follow Up 7 21 17
6-Month Follow Up 7 26 24
Completed 7 26 24
Not Completed 8 9 13
Reason Not Completed
Lost to Follow-up             8             9             10
Adverse Event             0             0             1
Protocol Violation             0             0             1
Withdrawal by Subject             0             0             1
Arm/Group Title Control CBT-I In-person CBT-I Telehealth Total
Hide Arm/Group Description Non-active intervention of sleep education delivered in-person Cognitive behavior therapy for insomnia (CBT-I) delivered in-person Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing Total of all reporting groups
Overall Number of Baseline Participants 7 25 23 55
Hide Baseline Analysis Population Description
patients who attended over 3 sessions and had a non-missing 3 month visit
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 25 participants 23 participants 55 participants
60.57  (10.05) 56.16  (10.84) 56.57  (11.24) 56.89  (10.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 25 participants 23 participants 55 participants
Female
1
  14.3%
5
  20.0%
0
   0.0%
6
  10.9%
Male
6
  85.7%
20
  80.0%
23
 100.0%
49
  89.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 25 participants 23 participants 55 participants
Caucasian
4
  57.1%
12
  48.0%
11
  47.8%
27
  49.1%
Black or African American
3
  42.9%
11
  44.0%
9
  39.1%
23
  41.8%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   4.3%
1
   1.8%
Unavailable (do not wish to provide information)
0
   0.0%
2
   8.0%
2
   8.7%
4
   7.3%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 7 participants 25 participants 23 participants 55 participants
32.05  (2.79) 34.02  (6.77) 34.31  (4.97) 33.89  (5.64)
1.Primary Outcome
Title Change From Baseline in Insomnia Severity Index Score
Hide Description 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.
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 25 23
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
6.68  (1.09) 5.13  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CBT-I In-person, CBT-I Telehealth
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing will be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I.
Statistical Test of Hypothesis P-Value 0.138
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.03
Confidence Interval (2-Sided) 95%
-4.63 to 1.57
Parameter Dispersion
Type: Standard Deviation
Value: 1.33
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline PTSD Checklist-Military (PCL-M) Scores
Hide Description Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.30  (3.33) 5.73  (1.87) 5.22  (1.96)
3.Secondary Outcome
Title Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores
Hide Description 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.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.03  (1.36) 3.34  (0.71) 2.50  (0.76)
4.Secondary Outcome
Title Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Hide Description 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.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.30  (1.13) 0.23  (0.66) 0.51  (0.71)
5.Secondary Outcome
Title Change From Baseline in Nightmare Distress Questionnaire Scores
Hide Description Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.
Time Frame baseline to 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.78  (1.67) -2.65  (0.98) -0.11  (1.07)
6.Secondary Outcome
Title Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score
Hide Description 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.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.26  (2.79) 0.70  (1.55) 2.76  (1.65)
7.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score
Hide Description 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.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.31  (2.24) -1.37  (1.22) 0.14  (1.31)
8.Secondary Outcome
Title Change From Baseline in Work and Social Adjustment Scale Scores
Hide Description A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.54  (2.77) 0.01  (1.46) -0.85  (1.63)
9.Secondary Outcome
Title Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks
Hide Description 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.
Time Frame 2-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
62.5  (6.24) 76.8  (5.02) 74.1  (8.64)
10.Secondary Outcome
Title Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks
Hide Description 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.
Time Frame 2-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
47.5  (6.54) 46.7  (9.09) 44.8  (12.16)
11.Secondary Outcome
Title Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores
Hide Description Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.
Time Frame baseline to 3 months, scores converted to yearly
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: nights per year
-26.1  (20.13) 11.35  (11.39) -3.04  (12.65)
12.Secondary Outcome
Title Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores
Hide Description Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly
Time Frame baseline to 3 months (converted to yearly)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Least Squares Mean (Standard Error)
Unit of Measure: number of nightmares
-24.6  (23.87) 6.41  (13.48) -8.09  (15.27)
13.Secondary Outcome
Title Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks
Hide Description 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.
Time Frame 2-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
72.8  (11.15) 77.4  (7.57) 76.8  (8.41)
14.Secondary Outcome
Title Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks
Hide Description 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.
Time Frame 2-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description:
Non-active intervention of sleep education delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
Overall Number of Participants Analyzed 7 25 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
67.5  (10.15) 75.8  (7.54) 75.3  (10.28)
Time Frame Duration of study, an average of 2.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control CBT-I In-person CBT-I Telehealth
Hide Arm/Group Description Non-active intervention of sleep education delivered in-person Cognitive behavior therapy for insomnia (CBT-I) delivered in-person Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
All-Cause Mortality
Control CBT-I In-person CBT-I Telehealth
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Control CBT-I In-person CBT-I Telehealth
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/35 (0.00%)      1/37 (2.70%)    
Psychiatric disorders       
hospitalized for suicide ideation *  0/15 (0.00%)  0/35 (0.00%)  1/37 (2.70%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control CBT-I In-person CBT-I Telehealth
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      2/35 (5.71%)      0/37 (0.00%)    
Musculoskeletal and connective tissue disorders       
Gout *  0/15 (0.00%)  1/35 (2.86%)  1 0/37 (0.00%) 
Surgical and medical procedures       
Tonsillectomy *  0/15 (0.00%)  1/35 (2.86%)  1 0/37 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Samuel T. Kuna
Organization: Crescenz VA Medical Center
Phone: 215-823-4400
EMail: Samuel.Kuna@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01686438    
Other Study ID Numbers: IIR 11-296
First Submitted: September 6, 2012
First Posted: September 18, 2012
Results First Submitted: February 7, 2019
Results First Posted: August 29, 2019
Last Update Posted: August 29, 2019