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Improving Outcomes for Older Veterans With Chronic Back Pain and Depression

Improving Outcomes for Older Veterans With Chronic Back Pain and Depression (CDA 14-425)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03896035
Enrollment
50
Registered
2019-03-29
Start date
2019-03-28
Completion date
2022-06-30
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Chronic Back Pain, Depression

Keywords

Chronic Back Pain, Depression, Veterans, Aging

Brief summary

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.

Detailed description

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.

Interventions

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).

Sponsors

Dallas VA Medical Center
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

The research staff conducting outcomes assessments will be blinded to whether the subject is in active or waitlist group

Intervention model description

This pilot RCT will use a waitlist control

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Intervention CompletionThrough intervention delivery of 8 sessions, up to 24 weeksFeasibility Outcome includes percentage of participants completing each arm

Secondary

MeasureTime frameDescription
Pain Scale- PEG-3Through study completion, up to 1 yearPain intensity on 0-10 scale where higher values are worse pain; PEG-3 assesses 3 aspects of pain interference and averages these values
Roland Morris Disability Questionnaire (RMDQ)Through study completion, up to 1 yearDisability related to back pain. Scale ranges from 0-24 with larger numbers indicating worse disability related to chronic back pain
DepressionThrough study completion, up to 1 yearDepression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
24
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).
26
Total50

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyHealth/family health issues during COVID04
Overall StudyLost to Follow-up26
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicWaitlist Control GroupBehavioral Intervention GroupTotal
Age, Continuous71.21 years
STANDARD_DEVIATION 3.11
70.96 years
STANDARD_DEVIATION 3.49
71.08 years
STANDARD_DEVIATION 3.28
Depression12.75 units on a scale
STANDARD_DEVIATION 4.78
13.92 units on a scale
STANDARD_DEVIATION 4.89
13.36 units on a scale
STANDARD_DEVIATION 4.82
Pain Scale6.81 units on a scale
STANDARD_DEVIATION 1.78
6.76 units on a scale
STANDARD_DEVIATION 1.7
6.78 units on a scale
STANDARD_DEVIATION 1.72
Race/Ethnicity, Customized
Black, non-Hispanic
11 Participants10 Participants21 Participants
Race/Ethnicity, Customized
Hispanic, any race
2 Participants2 Participants4 Participants
Race/Ethnicity, Customized
White, non-Hispanic
11 Participants14 Participants25 Participants
Region of Enrollment
United States
24 Participants26 Participants50 Participants
Sex: Female, Male
Female
5 Participants5 Participants10 Participants
Sex: Female, Male
Male
19 Participants21 Participants40 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 26
other
Total, other adverse events
0 / 240 / 26
serious
Total, serious adverse events
0 / 240 / 26

Outcome results

Primary

Rate of Intervention Completion

Feasibility Outcome includes percentage of participants completing each arm

Time frame: Through intervention delivery of 8 sessions, up to 24 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Waitlist Control GroupRate of Intervention Completion22 Participants
Behavioral Intervention GroupRate of Intervention Completion15 Participants
Secondary

Depression

Depression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression

Time frame: Through study completion, up to 1 year

ArmMeasureValue (MEAN)Dispersion
Waitlist Control GroupDepression10 score on a scaleStandard Deviation 4.35
Behavioral Intervention GroupDepression7.4 score on a scaleStandard Deviation 4.9
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

Time frame: Through study completion, up to 1 year

ArmMeasureValue (MEAN)Dispersion
Waitlist Control GroupPain Scale- PEG-36.57 units on a scaleStandard Deviation 1.89
Behavioral Intervention GroupPain Scale- PEG-35.13 units on a scaleStandard Deviation 2.04
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

Time frame: Through study completion, up to 1 year

ArmMeasureValue (MEAN)Dispersion
Waitlist Control GroupRoland Morris Disability Questionnaire (RMDQ)17.10 score on a scaleStandard Deviation 4.05
Behavioral Intervention GroupRoland Morris Disability Questionnaire (RMDQ)13.07 score on a scaleStandard Deviation 4.22

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026