Brief Behavioral Insomnia Treatment Study

NCT ID: NCT02571452

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-06
• Study Completion Date: 2019-06-30

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.

Detailed Description

This study is a randomized, controlled trial of a telephone-based, brief insomnia treatment in primary care in order to accomplish the goal of improving psychosocial functioning in Veterans who meet criteria for Insomnia Disorder. The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include evaluating durability of treatment gains and obtaining feedback from participants about the utility and feasibility of the proposed insomnia treatment.

Conditions

Insomnia Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief Behavioral Treatment for Insomnia

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.

Group Type: EXPERIMENTAL

Brief Behavioral Treatment for Insomnia

Intervention Type: BEHAVIORAL

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.

Progressive Muscle Relaxation

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.

Group Type: ACTIVE_COMPARATOR

Progressive Muscle Relaxation

Intervention Type: BEHAVIORAL

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.

Interventions

Brief Behavioral Treatment for Insomnia

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.

Intervention Type: BEHAVIORAL

Progressive Muscle Relaxation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shira Maguen, PhD

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Locations

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35393934 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33022048 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D1539-I

Identifier Type: -

Identifier Source: org_study_id