Trial Outcomes & Findings for Improving Outcomes for Older Veterans With Chronic Back Pain and Depression (NCT NCT03896035)
NCT ID: NCT03896035
Last Updated: 2024-03-15
Results Overview
Feasibility Outcome includes percentage of participants completing each arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Through intervention delivery of 8 sessions, up to 24 weeks
Results posted on
2024-03-15
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
22
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Health/family health issues during COVID
|
0
|
4
|
Baseline Characteristics
Improving Outcomes for Older Veterans With Chronic Back Pain and Depression
Baseline characteristics by cohort
| Measure |
Waitlist Control Group
n=24 Participants
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
n=26 Participants
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).
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.21 years
STANDARD_DEVIATION 3.11 • n=5 Participants
|
70.96 years
STANDARD_DEVIATION 3.49 • n=7 Participants
|
71.08 years
STANDARD_DEVIATION 3.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, any race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Pain Scale
|
6.81 units on a scale
STANDARD_DEVIATION 1.78 • n=5 Participants
|
6.76 units on a scale
STANDARD_DEVIATION 1.70 • n=7 Participants
|
6.78 units on a scale
STANDARD_DEVIATION 1.72 • n=5 Participants
|
|
Depression
|
12.75 units on a scale
STANDARD_DEVIATION 4.78 • n=5 Participants
|
13.92 units on a scale
STANDARD_DEVIATION 4.89 • n=7 Participants
|
13.36 units on a scale
STANDARD_DEVIATION 4.82 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through intervention delivery of 8 sessions, up to 24 weeksFeasibility Outcome includes percentage of participants completing each arm
Outcome measures
| Measure |
Waitlist Control Group
n=24 Participants
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
n=26 Participants
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).
|
|---|---|---|
|
Rate of Intervention Completion
|
22 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Through 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
Outcome measures
| Measure |
Waitlist Control Group
n=21 Participants
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
n=15 Participants
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).
|
|---|---|---|
|
Pain Scale- PEG-3
|
6.57 units on a scale
Standard Deviation 1.89
|
5.13 units on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Waitlist Control Group
n=21 Participants
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
n=15 Participants
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).
|
|---|---|---|
|
Roland Morris Disability Questionnaire (RMDQ)
|
17.10 score on a scale
Standard Deviation 4.05
|
13.07 score on a scale
Standard Deviation 4.22
|
SECONDARY outcome
Timeframe: Through study completion, up to 1 yearDepression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression
Outcome measures
| Measure |
Waitlist Control Group
n=21 Participants
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
n=15 Participants
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).
|
|---|---|---|
|
Depression
|
10 score on a scale
Standard Deviation 4.35
|
7.4 score on a scale
Standard Deviation 4.90
|
Adverse Events
Waitlist Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place