Post-Traumatic Stress Disorders, Sleep Initiation and Maintenance Disorders
Conditions
Keywords
cost effectiveness, patient satisfaction
Brief summary
Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD). Treatment of insomnia with a specialized type of psychotherapy has been shown to be more effective than treatment with medications. Unfortunately, few psychologists are trained to provide this treatment, limiting Veterans' access to care, especially those Veterans in remote and rural areas. This project will evaluate the ability to deliver this psychotherapy to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic insomnia will receive the psychotherapy treatment either by meeting in-person with the psychologist or by the psychologist delivering the treatment by video teleconferencing. Finding that video teleconferencing is a cost effective way to deliver this treatment could add an important new component to the care of Veterans with PTSD that provides an alternative to medications.
Detailed description
Objectives(s): The investigators are conducting a randomized, controlled trial of Veterans with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia (CBT-I) administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms. Secondary aims are 1) comparing the differences in cost and quality-adjusted life years between the treatment delivery approaches and 2) determining the effectiveness of CBT-I on functional outcomes, sleep quality, and non-sleep-related PTSD symptoms. The investigators are also conducting a patient- and provider-focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation. Research Design: This prospective randomized controlled non-inferiority study will determine if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an improvement in insomnia severity, as determined by change in Insomnia Severity Index (ISI) score, that is not clinically inferior to that in Veterans receiving in-person CBT-I. Differences in cost and quality-adjusted life years (QALY) between groups will also be compared. Methodology: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC are be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active control intervention. Participants are assessed at baseline, and 2 weeks and every 3 months following the intervention. The primary outcome measure in Aim 1 is the change in the Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods, with a pre-specified margin. Results will be ascertained via intent to treat and per-protocol procedures. The investigators hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery. In Aim 2, VA and non-VA total healthcare costs are being collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care. Preference is being assessed by the EuroQol and Health Utilities Index 2. Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes. Aim 3 is assessing the effect of CBT-I on functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the non-sleep component of the PTSD Checklist-Military). The investigators hypothesize that these functional outcomes and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative (targeted focus groups with participants and therapist interviews) and quantitative measures (Work Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future implementation of CBT-I by video teleconferencing Anticipated Findings: The investigators believe these results will demonstrate that: 1) Veterans in both CBT-I groups will have similar improvement in functional outcomes, and 2) treatment delivery by video teleconferencing will be more cost effective than in-person care. These findings should lead to wider acceptance of video teleconferencing, thereby increasing patient access to care and reducing treatment costs.
Interventions
BEHAVIORALCognitive behavioral therapy for insomnia
A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
Sponsors
University of Pennsylvania
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Veterans will have to meet the following inclusion criteria in order to be enrolled in this RCT: * Men and women at least 18 years of age. * Meet current DSM-IV-TR criteria for PTSD as determined by the Clinician Administered PTSD Scale (CAPS) * Insomnia Severity Index score \> 14, the commonly used threshold for clinical insomnia, with self-reported duration of insomnia \>6 months. * Ability to read and speak English (assessment instruments and therapy will be available only in English)
Exclusion criteria
Veterans will be excluded from participation if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Insomnia Severity Index Score | Baseline to 3 months | Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores | baseline to 3 months | Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score \< 5 is associated with good sleep quality. |
| Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) | baseline to 3 months | Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD. |
| Change From Baseline in Nightmare Distress Questionnaire Scores | baseline to 3 month | Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress. |
| Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score | baseline to 3 months | Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function. |
| Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score | baseline to 3 months | self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function. |
| Change From Baseline in Work and Social Adjustment Scale Scores | baseline to 3 months | A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment. |
| Change From Baseline PTSD Checklist-Military (PCL-M) Scores | baseline to 3 months | Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms. |
| Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks | 2-8 weeks | Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5. |
| Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores | baseline to 3 months, scores converted to yearly | Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly. |
| Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores | baseline to 3 months (converted to yearly) | Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly |
| Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks | 2-8 weeks | The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4. |
| Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks | 2-8 weeks | The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4. |
| Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks | 2-8 weeks | The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4. |
Countries
United States
Participant flow
Recruitment details
114 participants were consented and randomized in the study. 87 of those participants started in treatment in this study. Of those, 57 completed treatment sessions. 55 of the 57 who completed treatment are included in the analysis of this study.
Participants by arm
| Arm | Count |
|---|---|
| Control Non-active intervention of sleep education delivered in-person | 7 |
| CBT-I In-person Cognitive behavior therapy for insomnia (CBT-I) delivered in-person | 25 |
| CBT-I Telehealth Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing | 23 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 9 | 10 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Control | CBT-I In-person | CBT-I Telehealth | Total |
|---|---|---|---|---|
| Age, Continuous | 60.57 years STANDARD_DEVIATION 10.05 | 56.16 years STANDARD_DEVIATION 10.84 | 56.57 years STANDARD_DEVIATION 11.24 | 56.89 years STANDARD_DEVIATION 10.82 |
| Body Mass Index (BMI) | 32.05 kg/m^2 STANDARD_DEVIATION 2.79 | 34.02 kg/m^2 STANDARD_DEVIATION 6.77 | 34.31 kg/m^2 STANDARD_DEVIATION 4.97 | 33.89 kg/m^2 STANDARD_DEVIATION 5.64 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 11 Participants | 9 Participants | 23 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 12 Participants | 11 Participants | 27 Participants |
| Race/Ethnicity, Customized Unavailable (do not wish to provide information) | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 20 Participants | 23 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 2 / 35 | 0 / 37 |
| serious Total, serious adverse events | 0 / 15 | 0 / 35 | 1 / 37 |
Outcome results
Primary
Change From Baseline in Insomnia Severity Index Score
Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.
Time frame: Baseline to 3 months
Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations). This analysis was intended to only compare the two CBT-I groups for non-inferiority analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline in Insomnia Severity Index Score | 6.68 units on a scale | Standard Deviation 1.09 |
| CBT-I Telehealth | Change From Baseline in Insomnia Severity Index Score | 5.13 units on a scale | Standard Deviation 1.15 |
p-value: 0.13895% CI: [-4.63, 1.57]t-test, 1 sided
Secondary
Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score
self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.
Time frame: baseline to 3 months
Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score | 3.31 units on a scale | Standard Error 2.24 |
| CBT-I Telehealth | Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score | -1.37 units on a scale | Standard Error 1.22 |
| CBT-I Telehealth | Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score | 0.14 units on a scale | Standard Error 1.31 |
Secondary
Change From Baseline in Nightmare Distress Questionnaire Scores
Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.
Time frame: baseline to 3 month
Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline in Nightmare Distress Questionnaire Scores | -3.78 units on a scale | Standard Error 1.67 |
| CBT-I Telehealth | Change From Baseline in Nightmare Distress Questionnaire Scores | -2.65 units on a scale | Standard Error 0.98 |
| CBT-I Telehealth | Change From Baseline in Nightmare Distress Questionnaire Scores | -0.11 units on a scale | Standard Error 1.07 |
Secondary
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores
Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.
Time frame: baseline to 3 months, scores converted to yearly
Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores | -26.1 nights per year | Standard Error 20.13 |
| CBT-I Telehealth | Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores | 11.35 nights per year | Standard Error 11.39 |
| CBT-I Telehealth | Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores | -3.04 nights per year | Standard Error 12.65 |
Secondary
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores
Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly
Time frame: baseline to 3 months (converted to yearly)
Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores | -24.6 number of nightmares | Standard Error 23.87 |
| CBT-I Telehealth | Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores | 6.41 number of nightmares | Standard Error 13.48 |
| CBT-I Telehealth | Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores | -8.09 number of nightmares | Standard Error 15.27 |
Secondary
Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.
Time frame: baseline to 3 months
Population: Patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) | 0.30 units on a scale | Standard Error 1.13 |
| CBT-I Telehealth | Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) | 0.23 units on a scale | Standard Error 0.66 |
| CBT-I Telehealth | Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) | 0.51 units on a scale | Standard Error 0.71 |
Secondary
Change From Baseline in Work and Social Adjustment Scale Scores
A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.
Time frame: baseline to 3 months
Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline in Work and Social Adjustment Scale Scores | -0.54 units on a scale | Standard Error 2.77 |
| CBT-I Telehealth | Change From Baseline in Work and Social Adjustment Scale Scores | 0.01 units on a scale | Standard Error 1.46 |
| CBT-I Telehealth | Change From Baseline in Work and Social Adjustment Scale Scores | -0.85 units on a scale | Standard Error 1.63 |
Secondary
Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score
Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.
Time frame: baseline to 3 months
Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score | 0.26 units on a scale | Standard Error 2.79 |
| CBT-I Telehealth | Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score | 0.70 units on a scale | Standard Error 1.55 |
| CBT-I Telehealth | Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score | 2.76 units on a scale | Standard Error 1.65 |
Secondary
Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores
Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score \< 5 is associated with good sleep quality.
Time frame: baseline to 3 months
Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores | 2.03 units on a scale | Standard Error 1.36 |
| CBT-I Telehealth | Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores | 3.34 units on a scale | Standard Error 0.71 |
| CBT-I Telehealth | Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores | 2.50 units on a scale | Standard Error 0.76 |
Secondary
Change From Baseline PTSD Checklist-Military (PCL-M) Scores
Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.
Time frame: baseline to 3 months
Population: Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Change From Baseline PTSD Checklist-Military (PCL-M) Scores | 3.30 units on a scale | Standard Error 3.33 |
| CBT-I Telehealth | Change From Baseline PTSD Checklist-Military (PCL-M) Scores | 5.73 units on a scale | Standard Error 1.87 |
| CBT-I Telehealth | Change From Baseline PTSD Checklist-Military (PCL-M) Scores | 5.22 units on a scale | Standard Error 1.96 |
Secondary
Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks
Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.
Time frame: 2-8 weeks
Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks | 47.5 score on a scale | Standard Deviation 6.54 |
| CBT-I Telehealth | Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks | 46.7 score on a scale | Standard Deviation 9.09 |
| CBT-I Telehealth | Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks | 44.8 score on a scale | Standard Deviation 12.16 |
Secondary
Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
Time frame: 2-8 weeks
Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks | 72.8 score on a scale | Standard Deviation 11.15 |
| CBT-I Telehealth | Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks | 77.4 score on a scale | Standard Deviation 7.57 |
| CBT-I Telehealth | Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks | 76.8 score on a scale | Standard Deviation 8.41 |
Secondary
Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
Time frame: 2-8 weeks
Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks | 67.5 score on a scale | Standard Deviation 10.15 |
| CBT-I Telehealth | Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks | 75.8 score on a scale | Standard Deviation 7.54 |
| CBT-I Telehealth | Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks | 75.3 score on a scale | Standard Deviation 10.28 |
Secondary
Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
Time frame: 2-8 weeks
Population: patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I In-person | Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks | 62.5 score on a scale | Standard Deviation 6.24 |
| CBT-I Telehealth | Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks | 76.8 score on a scale | Standard Deviation 5.02 |
| CBT-I Telehealth | Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks | 74.1 score on a scale | Standard Deviation 8.64 |