Trial Outcomes & Findings for Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia (NCT NCT01549899)
NCT ID: NCT01549899
Last Updated: 2025-04-17
Results Overview
Provides daily self-reports of bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine self-reported sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
185 participants
Primary outcome timeframe
Change from Baseline to Post-Treatment and 6 month follow-up
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
In-person CBT of Insomnia
CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring.
In-person Cognitive Behavioral Therapy of Insomnia: In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education \& hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy).
|
Internet CBT of Insomnia
Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the 6 ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
|
Minimal Contact
Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
34
|
76
|
|
Overall Study
COMPLETED
|
63
|
27
|
68
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
Baseline characteristics by cohort
| Measure |
In-person CBT of Insomnia
n=75 Participants
CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring.
In-person Cognitive Behavioral Therapy of Insomnia: In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education \& hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy).
|
Internet CBT of Insomnia
n=34 Participants
Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the 6 ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
|
Minimal Contact
n=76 Participants
Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.21 Years
STANDARD_DEVIATION 7.18 • n=5 Participants
|
34.53 Years
STANDARD_DEVIATION 8.27 • n=7 Participants
|
32.67 Years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
32.44 Years
STANDARD_DEVIATION 7.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
39 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upProvides daily self-reports of bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine self-reported sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time.
Outcome measures
| Measure |
In-person CBT of Insomnia
n=33 Participants
CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring.
In-person Cognitive Behavioral Therapy of Insomnia: In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education \& hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy).
|
Internet CBT of Insomnia
n=34 Participants
The I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its aut
|
Minimal Contact
n=33 Participants
Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups.
|
|---|---|---|---|
|
Sleep Diary Sleep Efficiency
Baseline
|
73.2 Percentage Total Sleep Time/Time in Bed
Standard Error 2.2
|
72.5 Percentage Total Sleep Time/Time in Bed
Standard Error 2.1
|
72.9 Percentage Total Sleep Time/Time in Bed
Standard Error 2.2
|
|
Sleep Diary Sleep Efficiency
Post-treatment
|
84.5 Percentage Total Sleep Time/Time in Bed
Standard Error 2.2
|
79.4 Percentage Total Sleep Time/Time in Bed
Standard Error 2.4
|
73.1 Percentage Total Sleep Time/Time in Bed
Standard Error 2.3
|
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upMeasure of self-reported depression symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upSelf-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upA wrist worn accelerometer that measures activity level and then uses validated algorithms to determine objectively daily bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine objective sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upMeasures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upSelf-report measure of anxiety symptoms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upSelf-report insomnia symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upSelf-report daytime sleepiness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upSelf-reported beliefs and attitudes about sleep.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upSelf-reported fatigue symptoms across multiple dimensions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Post-Treatment and 6 month follow-upSelf-reported quality of life and health.
Outcome measures
Outcome data not reported
Adverse Events
In-person CBT of Insomnia
Serious events: 5 serious events
Other events: 47 other events
Deaths: 52 deaths
Internet CBT of Insomnia
Serious events: 0 serious events
Other events: 8 other events
Deaths: 8 deaths
Minimal Contact
Serious events: 1 serious events
Other events: 9 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
In-person CBT of Insomnia
n=75 participants at risk
CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring.
In-person Cognitive Behavioral Therapy of Insomnia: In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education \& hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy).
|
Internet CBT of Insomnia
n=34 participants at risk
The I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
|
Minimal Contact
n=76 participants at risk
Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups.
|
|---|---|---|---|
|
Psychiatric disorders
Hypomania
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
General disorders
Accident
|
4.0%
3/75 • Number of events 3 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
1.3%
1/76 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Nervous system disorders
Alcohol-Detox
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
Other adverse events
| Measure |
In-person CBT of Insomnia
n=75 participants at risk
CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring.
In-person Cognitive Behavioral Therapy of Insomnia: In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education \& hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy).
|
Internet CBT of Insomnia
n=34 participants at risk
The I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
|
Minimal Contact
n=76 participants at risk
Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups.
|
|---|---|---|---|
|
Nervous system disorders
Headache, Migraine
|
5.3%
4/75 • Number of events 4 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Nervous system disorders
Anxiety, Panic
|
2.7%
2/75 • Number of events 2 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Nervous system disorders
Insomnia
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Nervous system disorders
Sleep Walking
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Nervous system disorders
Stress
|
0.00%
0/75 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
2.9%
1/34 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Nervous system disorders
Memory, Blackout
|
0.00%
0/75 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
1.3%
1/76 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Nervous system disorders
Fatigue
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Infections and infestations
Cold/ flu
|
14.7%
11/75 • Number of events 11 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
2.9%
1/34 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
3.9%
3/76 • Number of events 3 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
General disorders
Allergies
|
6.7%
5/75 • Number of events 5 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
1.3%
1/76 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
1.3%
1/76 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Infections and infestations
Infection
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Musculoskeletal and connective tissue disorders
Pain, Arthritis
|
12.0%
9/75 • Number of events 9 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
5.9%
2/34 • Number of events 2 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
General disorders
Skin Rash
|
4.0%
3/75 • Number of events 3 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
2.9%
1/34 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
1.3%
1/76 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Gastrointestinal disorders
GI disturbance
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
5.9%
2/34 • Number of events 2 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
1.3%
1/76 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
Eye disorders
Visual Disturbance
|
1.3%
1/75 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/34 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
0.00%
0/76 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
|
General disorders
Other
|
4.0%
3/75 • Number of events 3 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
2.9%
1/34 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
1.3%
1/76 • Number of events 1 • Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was \~\>66% more often in the In-person than other two groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place