Improving Outcomes for Older Veterans With Chronic Back Pain and Depression
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Back Pain, Depression, Depression, Healthy Studies |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 3/31/2019 |
| Start Date: | March 2019 |
| End Date: | December 2021 |
| Contact: | Cassie Lusk, CCRP |
| Email: | cassie.lusk@va.gov |
| Phone: | 214-857-2602 |
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.
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.
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.
Inclusion Criteria:
- Men and women Veterans aged 65+
- English- speaking
- Self-reported low back pain (+/-radiation) on most days for the past 3 months, that
interferes with daily activities. Low back pain interferes with daily activities,
assessed with the question "does your back pain limit your ability to do activities
around the home or activities that you enjoy?"
- Chronic low back pain with intensity of 4 or higher on 10 point scale
- Depression, PHQ-9>10 stable (per chart review, no psychotic or suicidal ideation;
confirmed over telephone)
- Capable of participating in home-based activity
Exclusion Criteria:
- No telephone
- Not English speaking
- Unwilling to be randomized to either study arm
- Self-reported uncorrected hearing or visual disturbance precluding ability to
participate in telephone sessions or read pedometer screen
- Cognitive impairment, assessed by Memory Impairment Screen
- Lumbar surgery within the last year
- Self-reported dependence on wheelchair, bed-bound, or severe balance impairment
(unable to participate in physical activity intervention)
- Illness requiring hospitalization within the last 3 months. Specific question: Have
you been hospitalized for an illness in the past 3 months that would make
participating in a physical activity program challenging or unsafe? (Examples include:
fall, gout attacks, stroke, heart attack, heart failure, or surgery for blocked
arteries)
- Suicidal ideation, prior psychotic episodes requiring hospitalization within the last
year
- Already achieving physical activity goals of > 4 hours per week. Recommendation are
for >150 minutes/ week of moderate activity. Four hours is 240 minutes and exceeds
this threshold.
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