NCT02571452

Brief Summary

The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

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

First Submitted

Initial submission to the registry

October 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 6, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

February 7, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

October 2, 2015

Results QC Date

January 8, 2020

Last Update Submit

January 28, 2020

Conditions

Insomnia Disorder

Keywords

VeteranInsomniaPrimary Healthcare

Outcome Measures

Primary Outcomes (2)

  • Work and Social Adjustment Scale (WSAS)

    The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) \& Post-treatment (week 5).

    Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate

  • Work and Social Adjustment Scale (WSAS)

    The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.

    Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only

Secondary Outcomes (2)

  • Insomnia Severity (ISI)

    Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate

  • Insomnia Severity (ISI)

    Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only

Study Arms (2)

Brief Behavioral Treatment for Insomnia

EXPERIMENTAL

Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.

Behavioral: Brief Behavioral Treatment for Insomnia

Progressive Muscle Relaxation

ACTIVE COMPARATOR

Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.

Behavioral: Progressive Muscle Relaxation

Interventions

Brief Behavioral Treatment for InsomniaBEHAVIORAL

Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.

Brief Behavioral Treatment for Insomnia
Progressive Muscle RelaxationBEHAVIORAL

Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.

Progressive Muscle Relaxation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans between the ages of 18-75 years.
  • Meet DSM-5 Criteria for Insomnia Disorder.
  • Able attend in-person appointments at the San Francisco VA Medical Center
  • The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.
  • Specifically, individuals receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will not be excluded provided they meet the criteria described above.
  • The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.
  • However, individual who need to start a new type of psychotherapy during the course of the treatment will be excluded, or they will need to wait three months in order to enroll in the trial.
  • The investigators will not exclude individuals with TBI.
  • The investigators will not exclude individuals with chronic pain.
  • The investigators will not exclude individuals based on any other mental health condition, including posttraumatic stress disorder and depression.

You may not qualify if:

  • Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
  • Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
  • Veterans with suicidal or homicidal ideation.
  • Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
  • Veterans who work night or rotating shifts.
  • Veterans with untreated moderate to severe sleep apnea (those receiving treatment will not be excluded from the study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (2)

  • Ranney RM, Gloria R, Metzler TJ, Huggins J, Neylan TC, Maguen S. Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. J Clin Sleep Med. 2022 Jul 1;18(7):1831-1839. doi: 10.5664/jcsm.10002.

    PMID: 35393934DERIVED

  • Maguen S, Gloria R, Huggins J, Goldstein LA, Kanady JC, Straus LD, Metzler TJ, Lujan C, Neylan TC. Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Sleep. 2021 Mar 12;44(3):zsaa205. doi: 10.1093/sleep/zsaa205.

    PMID: 33022048DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Shira Maguen
Organization
San Francisco VA Healthcare System
Shira.Maguen@va.gov
415-221-4810

Study Officials

  • Shira Maguen, PhD

    San Francisco VA Medical Center, San Francisco, CA

    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
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 8, 2015

Study Start

January 6, 2016

Primary Completion

March 31, 2019

Study Completion

June 30, 2019

Last Updated

February 7, 2020

Results First Posted

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)