Tele-Self CBTI Trial

Summary

Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia has been shown to play a causal role in mental health, hypertension, obesity, and other health conditions, increasing risk for all-cause mortality. Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and sustained resolution of insomnia with fewer adverse side effects than medications, but access to behavioral sleep medicine expertise within the VA is very limited.

This study compares Tele-Self CBTI to Health Education Control for improved insomnia severity among treatment-seeking Veterans with Insomnia. In this study, 200 participants will be randomized with a 50/50 chance to either Tele-Self CBTI or a Health Education Control condition. Eligible participants are Veterans who are: a) prescribed sleep medications; b) diagnosed with insomnia; and/or c) referred for clinic-based CBTI (but not yet treated) for insomnia. Participants will be identified using electronic health records (EHR) and telephone interviews.

Participants' sleep will be assessed at three time points, at Baseline, 8 weeks and 6 months after Baseline. The Tele-Self CBTi intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period. Participants randomized to Tele-Self CBTI will complete 6 weekly readings in addition to having 6 weekly telephone contacts with a study nurse; each call lasting approximately 20 minutes. Patients randomized to Health Education Control (HEC) will receive a health education manual on 6 health topics. They will also complete 6 weekly readings from the HEC manual and receive 6 weekly telephone contacts from a study nurse. All participants will continue to receive usual medical care while participating in the study. Following completion of this 6 month study, participants randomized to HEC and interested in additional help for their sleep will be referred to the Durham VA Behavioral Sleep Medicine Clinic.

Conditions

• Insomnia Disorder

Interventions

BEHAVIORAL

Tele-Self CBTI

The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period. Participants have 8 weeks to complete 6 study-related phone calls

OTHER

Health Education Control

The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 8 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Christi S. Ulmer, PhD · Durham VA Medical Center, Durham, NC

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-04

Primary Completion

2022-12-16

Completion

2023-04-01

Countries

• United States

Study Locations