NCT00881647

Brief Summary

This study will test the effectiveness of cognitive behavioral therapy for insomnia in treating sleep disturbances in people with post-traumatic stress disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 21, 2014

Completed
Last Updated

March 17, 2014

Status Verified

February 1, 2014

Enrollment Period

4.4 years

First QC Date

April 14, 2009

Results QC Date

January 7, 2014

Last Update Submit

February 20, 2014

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSDInsomnia DisorderInsomniaCBT

Outcome Measures

Primary Outcomes (3)

  • Sleep Latency (SL)

    In a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.

    After 8 weeks of study participation

  • Minutes of Wake After Sleep Onset (WASO)

    WASO was the sum of wake time during sleep as recorded in a self-report sleep diary, and as measured in epochs (30 seconds of polysomnography \[PSG\]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording \[i.e. awake epoch immediately prior to the end of the recording\]). This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.

    After 8 weeks of study participation

  • Sleep Efficiency (SE)

    SE, as determined by polysomnography (PSG) and by self-reported sleep diary, was the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.

    After 8 weeks of study participation

Study Arms (2)

1

EXPERIMENTAL

Participants will receive an 8-week course of cognitive behavioral therapy for insomnia.

Other: Cognitive Behavioral Treatment for Insomnia (CBT-I)

2

NO INTERVENTION

Participants will be placed on a waitlist for 8 weeks.

Interventions

Cognitive Behavioral Treatment for Insomnia (CBT-I)OTHER

CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic PTSD for at least 3 months
  • Currently on first line treatment for PTSD, defined as selective serotonin reuptake inhibitor (SSRI) therapy, for at least 6 months
  • Persistent residual insomnia

You may not qualify if:

  • Conditions or substances that may be associated with comorbid insomnia independent of PTSD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

Related Publications (2)

  • Kanady JC, Talbot LS, Maguen S, Straus LD, Richards A, Ruoff L, Metzler TJ, Neylan TC. Cognitive Behavioral Therapy for Insomnia Reduces Fear of Sleep in Individuals With Posttraumatic Stress Disorder. J Clin Sleep Med. 2018 Jul 15;14(7):1193-1203. doi: 10.5664/jcsm.7224.

    PMID: 29991428DERIVED

  • Talbot LS, Maguen S, Metzler TJ, Schmitz M, McCaslin SE, Richards A, Perlis ML, Posner DA, Weiss B, Ruoff L, Varbel J, Neylan TC. Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. Sleep. 2014 Feb 1;37(2):327-41. doi: 10.5665/sleep.3408.

    PMID: 24497661DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Thomas C. Neylan, MD
Organization
University of California, San Francisco
thomas.neylan@ucsf.edu
415-750-6961

Study Officials

  • Thomas C. Neylan, MD

    University of California, San Francisco/VA Medical Center, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

November 1, 2008

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 17, 2014

Results First Posted

February 21, 2014

Record last verified: 2014-02

Locations

US(1)