Brief Behavioral Insomnia Treatment Study

Insomnia Disorder Clinical Trial

— BBTI  

Official title:

Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571452
• Other study ID #: D1539-I
• Status: Completed
• Phase: N/A
• Start date: January 6, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Insomnia Severity (ISI)	The ISI is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, 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
Secondary	Insomnia Severity (ISI)	Insomnia Severity Index (ISI) is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The ISI 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