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Managing Sleep Symptoms and Modifying Mechanisms of Traumatic Stress

NCT01743339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-04-27

No results posted yet for this study

Summary

The primary purpose of this study is to test whether and how cognitive-behavioral therapy for insomnia (CBTi), a well-supported and highly effective insomnia treatment, may directly improve Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) symptoms. The study is designed as a randomized controlled trial (RCT) to test the effect of CBTi on symptoms of PTSD and co-morbid depression prior to an evidence-based PTSD intervention and to assess the role of neurobiological processes and sleep architecture in mediating treatment outcomes.

Conditions

  • Stress Disorders, Post-Traumatic
  • Depression
  • Sleep

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Insomnia(4 individual therapy sessions over 5 weeks) will consist of a standard, structured, multi-component CBT intervention (sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention) Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions

BEHAVIORAL

Control

Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • Wilfred R. Pigeon, Ph.D. · University of Rochester

  • Kathi L. Heffner, Ph.D. · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01743339 on ClinicalTrials.gov