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

Insomnia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:In-person Cognitive Behavioral Therapy of Insomnia

Behavioral:Internet Cognitive Behavioral Therapy of InsomniaThe 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

In-person CBT of InsomniaCBTi 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.

Internet CBT of InsomniaThe 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.

Minimal ContactThose 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.

Study Status

Completed

Start Date: March 2012

Completed Date: September 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Sleep Diary

Secondary Outcome: Beck Depression Inventory II

Study sponsors, principal investigator, and references

Principal Investigator: Daniel J Taylor, Ph.D.

Lead Sponsor: Dr. Daniel Taylor

Collaborator: United States Department of Defense

More information:https://clinicaltrials.gov/show/NCT01549899

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