Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01549899

Enrollment

185

Registered

2012-03-09

Start date

2012-03-31

Completion date

2015-09-30

Last updated

2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Insomnia, Cognitive, Behavioral, Therapy, Internet, Depression, Substance Use, Post-Tramatic Stress Disorder

Brief summary

The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The investigators will compare these three groups on subjective and objective measures of sleep. The CBTi and MC control groups will be compared on other variables of interest (e.g., depression, substance abuse, and PTSD symptoms) and predictors of outcomes.

Interventions

BEHAVIORALIn-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).

BEHAVIORALInternet 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Chronic Insomnia as defined by Research Diagnostic Criteria (RDC) criteria41 Complaint of \> 3 months (chronic insomnia) of disturbed sleep \>3 nights/week (severe insomnia) as defined by at least one of the following as assessed by sleep diaries: Sleep Onset Latency of \>30 min (initial insomnia) and/or Wake After Sleep-Onset of \>30 min (middle insomnia) and/or Early Morning Awakening of \>30 min before the desired wakeup time (late insomnia) and Sleep Efficiency \< 85% * Active Duty military member stationed at Fort Hood as assessed by self-report. * History of having deployed in support of OIF or OEF as assessed by self-report. • Stable on psychotropic and/or hypnotic medications for at least one month as assessed by self-report and review of medical record.

Design outcomes

Primary

Measure	Time frame	Description
Sleep Diary Sleep Efficiency	Change from Baseline to Post-Treatment and 6 month follow-up	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.

Secondary

Measure	Time frame	Description
Beck Depression Inventory II	Change from Baseline to Post-Treatment and 6 month follow-up	Measure of self-reported depression symptoms.
Substance Use	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.
Actigraphy	Change from Baseline to Post-Treatment and 6 month follow-up	A 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.
PTSD Check List-Military	Change from Baseline to Post-Treatment and 6 month follow-up	Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.
Veterans Rand 12-Item Health Survey	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported quality of life and health.
Insomnia Severity Index	Change from Baseline to Post-Treatment and 6 month follow-up	Self-report insomnia symptoms.
Epworth Sleepiness Scale	Change from Baseline to Post-Treatment and 6 month follow-up	Self-report daytime sleepiness.
Dysfunctional Beliefs and Attitudes About Sleep Scale	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported beliefs and attitudes about sleep.
Multidimensional Fatigue Inventory	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported fatigue symptoms across multiple dimensions.
Beck Anxiety Inventory	Change from Baseline to Post-Treatment and 6 month follow-up	Self-report measure of anxiety symptoms

Countries

United States

Participant flow

Participants by arm

Arm	Count
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).	75
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.	34
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.	76
Total	185

Baseline characteristics

Characteristic	In-person CBT of Insomnia	Internet CBT of Insomnia	Minimal Contact	Total
Age, Continuous	32.21 Years STANDARD_DEVIATION 7.18	34.53 Years STANDARD_DEVIATION 8.27	32.67 Years STANDARD_DEVIATION 7.97	32.44 Years STANDARD_DEVIATION 7.57
Race/Ethnicity, Customized African American	19 Participants	8 Participants	27 Participants	54 Participants
Race/Ethnicity, Customized Caucasian	39 Participants	21 Participants	30 Participants	90 Participants
Race/Ethnicity, Customized Hispanic	14 Participants	3 Participants	12 Participants	29 Participants
Race/Ethnicity, Customized Other	3 Participants	2 Participants	7 Participants	12 Participants
Sex: Female, Male Female	13 Participants	6 Participants	14 Participants	33 Participants
Sex: Female, Male Male	62 Participants	28 Participants	62 Participants	152 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	52 / 75	8 / 34	10 / 76
other Total, other adverse events	47 / 75	8 / 34	9 / 76
serious Total, serious adverse events	5 / 75	0 / 34	1 / 76

Outcome results

Primary

Sleep Diary Sleep Efficiency

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.