Insomnia Disorder
Conditions
Keywords
Veteran, Insomnia, Primary Healthcare
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.
Interventions
BEHAVIORALBrief 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.
BEHAVIORALProgressive 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.
Sponsors
University of California, San Francisco
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work and Social Adjustment Scale (WSAS) | Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity (ISI) | Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate | 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). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 1/6/16 to 8/9/18 through local advertisements, referrals from other research studies or VA clinicians and direct mailings to veterans that had established care at the San Francisco VA (SFVA) or that lived within a 40-mile radius of the SFVA.
Pre-assignment details
A total of 157 people provided consent for screening, 119 completed screening and 93 were eligible, enrolled and randomized to treatment. Of the 93, two were withdrawn during treatment or 6-month follow-up due to no longer meeting eligibility and two were pilot subjects that didn't meet inclusion criteria and weren't included in data analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 47 |
| Progressive Muscle Relaxation Training 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: 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. | 46 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study 6-Month Follow-up | Lost to Follow-up | 4 | 0 |
| Overall Study 6-Month Follow-up | Protocol Violation | 1 | 0 |
| Overall Study Treatment | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Brief Behavioral Treatment for Insomnia | Total | Progressive Muscle Relaxation Training |
|---|---|---|---|
| Age, Continuous | 48.87 years STANDARD_DEVIATION 15.66 | 49.32 years STANDARD_DEVIATION 15.48 | 49.80 years STANDARD_DEVIATION 15.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 77 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 17 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 22 Participants | 46 Participants | 24 Participants |
| Region of Enrollment United States | 46 participants | 91 participants | 45 participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 37 Participants | 73 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 46 |
| other Total, other adverse events | 0 / 47 | 0 / 46 |
| serious Total, serious adverse events | 0 / 47 | 0 / 46 |
Outcome results
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.
Time frame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
Population: An intent-to-treat analysis was conducted on the 46 participants that completed BBTI treatment. Participants in the PMRT group did not complete the 6-month follow-up assessment and were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Treatment for Insomnia | Work and Social Adjustment Scale (WSAS) | Post-Treatment | 10.8 score on a scale | Standard Deviation 9.3 |
| Brief Behavioral Treatment for Insomnia | Work and Social Adjustment Scale (WSAS) | 6-month follow-up | 11.2 score on a scale | Standard Deviation 10.3 |
p-value: 0.56895% CI: [-1.26, 2.3]Mixed Models Analysis
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).
Time frame: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Population: An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Treatment for Insomnia | Work and Social Adjustment Scale (WSAS) | Baseline | 20.1 score on a scale | Standard Deviation 9.6 |
| Brief Behavioral Treatment for Insomnia | Work and Social Adjustment Scale (WSAS) | Mid-Treatment | 14.1 score on a scale | Standard Deviation 9.1 |
| Brief Behavioral Treatment for Insomnia | Work and Social Adjustment Scale (WSAS) | Post-Treatment | 10.8 score on a scale | Standard Deviation 9.3 |
| Progressive Muscle Relaxation | Work and Social Adjustment Scale (WSAS) | Baseline | 19.7 score on a scale | Standard Deviation 8.9 |
| Progressive Muscle Relaxation | Work and Social Adjustment Scale (WSAS) | Mid-Treatment | 15.8 score on a scale | Standard Deviation 9.5 |
| Progressive Muscle Relaxation | Work and Social Adjustment Scale (WSAS) | Post-Treatment | 14.1 score on a scale | Standard Deviation 10 |
p-value: 0.02195% CI: [-6.65, -0.55]Mixed Models Analysis
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).
Time frame: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Population: An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Treatment for Insomnia | Insomnia Severity (ISI) | Baseline | 17.1 score on a scale | Standard Deviation 3.6 |
| Brief Behavioral Treatment for Insomnia | Insomnia Severity (ISI) | Mid-Treatment | 10.4 score on a scale | Standard Deviation 4.6 |
| Brief Behavioral Treatment for Insomnia | Insomnia Severity (ISI) | Post-Treatment | 8.1 score on a scale | Standard Deviation 5.4 |
| Progressive Muscle Relaxation | Insomnia Severity (ISI) | Baseline | 17.4 score on a scale | Standard Deviation 4 |
| Progressive Muscle Relaxation | Insomnia Severity (ISI) | Mid-Treatment | 14.2 score on a scale | Standard Deviation 4.3 |
| Progressive Muscle Relaxation | Insomnia Severity (ISI) | Post-Treatment | 12.4 score on a scale | Standard Deviation 5.4 |
p-value: <0.00195% CI: [-5.87, -2.33]Mixed Models Analysis
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.
Time frame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
Population: An intent-to-treat analysis was conducted on the 46 participants that completed BBTI treatment. Participants in the PMRT group did not complete the 6-month follow-up assessment and were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Treatment for Insomnia | Insomnia Severity (ISI) | Post-Treatment | 8.1 score on a scale | Standard Deviation 5.4 |
| Brief Behavioral Treatment for Insomnia | Insomnia Severity (ISI) | 6-month follow-up | 7.5 score on a scale | Standard Deviation 5.7 |
p-value: 0.17395% CI: [-1.61, 0.29]Mixed Models Analysis