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| ID | Type | Description | Link |
|---|---|---|---|
| K2HX001916 | Other Identifier | VA HSRD |
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| Name | Class |
|---|---|
| Dallas VA Medical Center | FED |
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The overarching goal of this study is to develop and evaluate a telephone delivered behavioral change intervention for older Veterans with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related pain, depressive symptoms, and disability.
Investigators will conduct a pilot randomized controlled trial to assess feasibility for older Veterans with cLBP and depression assigned to receive the behavioral interventions (n=25) versus waitlist control (n=25). For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments.
In this pilot RCT, investigators will assess the feasibility for older Veterans with cLBP and depression assigned to receive the behavioral intervention (n=25) versus the waitlist control (n=25). Follow-up will also include assessments at 6 months and 12 months post-intervention.
Overview of Proposed intervention: The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). Exceptions may be made for highly motivated subjects who had unfortunate life circumstances arise.
For the physical activity component of the intervention, investigators will provide an Omron pedometer to subjects, as previously used in VA research studies. The Omron pedometer will be set up by the research team (stride length, setting date/time) and will be mailed to the subject's home in between session 1 and 2. The health coach will remind the subject that this pedometer will arrive via United States Postal Service mail to their home and to call the research coordinator when it arrives. The research team will provide technical assistance and instructions to the subject regarding use of the Omron pedometer (to be worn on the waist band, daily, all day aside from showers/baths). The research team will also verbally show the subject how to press the mode and memory buttons to obtain weekly step counts for documentation/tracking physical activity. The subjects will be prompted by the health coach or research staff to report out weekly step counts during subsequent coaching sessions.
In addition to the assessments outlined later in this protocol, specifically at 12 months, investigators will conduct in-depth semi-structured interviews with ~10-15 participants (8 from both arms of the pilot trial, the health coaches, 2 primary care providers, and 1 mental health provider) using purposive sampling. The health coach/research coordinator will identify Veterans who are at higher risk for drop-out, were less engaged, or were particularly successful at achieving behavioral change. The purpose of this final interview is to learn about the barriers and facilitators to successful intervention delivery and participant retention from the Veteran, health coach, and provider perspective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waitlist Control Group | No Intervention | The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments. | |
| Behavioral Intervention Group | Experimental | For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention Group | Behavioral | The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Intervention Completion | Feasibility Outcome includes percentage of participants completing each arm | Through intervention delivery of 8 sessions, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scale- PEG-3 | Pain intensity on 0-10 scale where higher values are worse pain; PEG-3 assesses 3 aspects of pain interference and averages these values | Through study completion, up to 1 year |
| Roland Morris Disability Questionnaire (RMDQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Una E. Makris, MD MSc | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Waitlist Control Group | The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments. |
| FG001 | Behavioral Intervention Group | For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Behavioral Intervention Group: The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Waitlist Control Group | The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Intervention Completion | Feasibility Outcome includes percentage of participants completing each arm | Posted | Count of Participants | Participants | Through intervention delivery of 8 sessions, up to 24 weeks |
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Adverse event data reported over 1 year period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Waitlist Control Group | The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments. |
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This pilot trial was designed to assess feasibility: ability to recruit, refine protocols and procedures and retain participants. The pilot trial was active during 2019-2020 when COVID restrictions were severe, locally, and several participants in the active arm were lost to follow-up for health related reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Una Makris, MD (PI) | VANTHCS | 2148570240 | una.makris2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2021 | Apr 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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This pilot RCT will use a waitlist control
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The research staff conducting outcomes assessments will be blinded to whether the subject is in active or waitlist group
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Disability related to back pain. Scale ranges from 0-24 with larger numbers indicating worse disability related to chronic back pain
| Through study completion, up to 1 year |
| Depression | Depression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression | Through study completion, up to 1 year |
| Health/family health issues during COVID |
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| BG001 | Behavioral Intervention Group | For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Behavioral Intervention Group: The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pain Scale | PEG-3 measures pain interference. Pain intensity on 0-10 scale where higher values are worse pain. | Mean | Standard Deviation | units on a scale |
|
| Depression | PHQ-9 measures depressive symptom severity. Scored between 0-27 with higher numbers indicated worse depression. | Mean | Standard Deviation | units on a scale |
|
For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Behavioral Intervention Group: The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). |
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| Secondary | Pain Scale- PEG-3 | Pain intensity on 0-10 scale where higher values are worse pain; PEG-3 assesses 3 aspects of pain interference and averages these values | Posted | Mean | Standard Deviation | units on a scale | Through study completion, up to 1 year |
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|
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| Secondary | Roland Morris Disability Questionnaire (RMDQ) | Disability related to back pain. Scale ranges from 0-24 with larger numbers indicating worse disability related to chronic back pain | Posted | Mean | Standard Deviation | score on a scale | Through study completion, up to 1 year |
|
|
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| Secondary | Depression | Depression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression | Posted | Mean | Standard Deviation | score on a scale | Through study completion, up to 1 year |
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|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Behavioral Intervention Group | For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Behavioral Intervention Group: The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). | 0 | 26 | 0 | 26 | 0 | 26 |
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