Back Pain Lower Back ChronicNCT03914469
MOTIVATE: Moving to Improve Outcomes for Older Adults
A study testing Behavioral Intervention Group in people with Back Pain Lower Back Chronic, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
The overarching goal of this study is to evaluate a tele-based behavioral change intervention for older adults (aged 50 years and older) with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related disability and depressive symptoms. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Behavioral Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2019to 6 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 and older
- English- speaking
- Working telephone
- Capable of participating in home-based activity
- Chronic low back pain with intensity of 4 or higher on 10 point scale
- Self-reported low back pain (+/-radiation) in the past 3 months that interferes with daily activities on most days
- Depression, PHQ-9>10 stable (per chart review, no psychotic or suicidal ideation; confirmed over telephone)
Who cannot join
- Aged 49 or less
- 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
Show all 10Show fewer
- 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 (e.g., fall, gout attacks, stroke, heart attack, heart failure, or surgery for blocked arteries)
- Suicidal ideation or prior psychotic episodes requiring hospitalization within the last year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkland Health & Hospital System
Dallas, Texas, 75235
UT Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: MOTIVATE: Moving to Improve Chronic Back Pain and Depression in Older Adults
The overarching goal of this study is to evaluate a tele-based behavioral change intervention for older adults (aged 50 years and older) with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related disability and depressive symptoms.
Investigators will conduct a pilot randomized control trial to assess feasibility for older adults with chronic low back pain and depression to receive a behavioral change tele-based intervention delivered by a health coach trained in motivational interviewing. All participants, regardless of intervention arm assigned, will undergo outcomes assessments (baseline, mid-point, final assessments) conducted by a blinded research assistant.
Read the detailed description
Investigators will assess the feasibility of a tele-delivered behavioral change intervention among older adults (aged 50 and older) with chronic low back pain and depression. Fifty participants will be randomly assigned to one of two groups, behavioral intervention arm (n=25) versus the waitlist control arm (n=25). The active intervention will include eight tele-delivered health coach sessions, three tele-based outcome assessments, and up to two semi-structured interviews within 6 months of completion, post-intervention. Each tele-based outcome assessment is roughly 45-60 minutes and will be conducted by a member of the research team. Each intervention session will be delivered by a trained health coach over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).
The first session will introduce the participant to the health coach and the program, establish rapport, and measure baseline physical activity. The following six sessions address behavioral determinants, followed by a final session designed to be a booster session to the overall program.
An Omron pedometer will be provided to each participant for the assessment of physical activity. The Omron pedometer will be set up by a member of the research team (e.g., stride length, setting date/time) and will be mailed to the participant's home address between sessions one and two. Each participant will receive a courtesy phone call when the pedometer is mailed and will be asked to call the research coordinator when it arrives. The research team will provide technical assistance and instructions to the participant regarding use. The pedometer is intended to be worn on the waist band, daily, with the exception of times when the participant may shower or bathe. The research team will verbally instruct the participant on how to press the mode and memory buttons in order to provide weekly step counts for tracking physical activity. The participants will be prompted by the health coach or research staff to report step counts during subsequent weekly tele-based coaching sessions.
Since the investigators are interested in better understanding feasibility of the intervention as compared to the waitlist control, and how behaviors are sustained over time, the study involves follow-up to 6 months. Investigators will use these follow-up data to better understand differential attrition as well as preliminary formative implementation evaluation. Using purposive sampling, investigators will conduct ~ 10 in-depth semi-structured interviews. Each interview will occur ~six months post-intervention and will include key stakeholders from the following groups: study participants from each arm of the pilot study, the health coach, primary care and mental health providers.
The research staff will select participants identified as higher risk for drop-out, less engaged, or were particularly successful at achieving behavioral change. The purpose of the final interviews is to learn about the barriers and facilitators to successful intervention delivery and participant retention from the perspectives of the enrolled patients, health coach, and providers. Interview topics will borrow from components of the well-established framework, Promoting Action on Research Implementation in Health Services (PARiHS). Semi-structured interview strategy is informed by two Promoting Action on Research Implementation in Health Services (PARiHS) dimensions: context-how the microsystem (UTSW) impacts behavioral change uptake, for example, potential facilitators to intervention implementation; facilitation-identifying specific ways to augment the likelihood of implementation.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Behavioral Intervention Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention GroupBehavioural
The active intervention will include eight tele-delivered health coach sessions, three tele-based outcome assessments, and up to two semi-structured interviews at 6 months post-intervention. Each tele-based outcome assessment is roughly 45-60 minutes and will be conducted by a member of the research team. Each intervention session will be delivered by a trained health coach over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
Of patients pre-screened, the total number enrolled into the study
Measured: Through study completion, up to 6 months
Rate of Intervention Completion
Of patients randomized into the intervention arm, the total number retained for follow-up
Measured: Through study completion, up to 6 months
Secondary outcomes (4)
Pain Scale
Pain intensity on 0-10 scale where higher values are worse pain. The data reported is the averaged data for the end assessments.
Measured: at approximately 4 months
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. The data reported is the averaged data for the end assessments.
Measured: at approximately 4 months
Depression
Depression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression. The data reported is the averaged data for the end assessments.
Measured: at approximately 4 months
Step Counts
Physical activity: step counts measured using Omron pedometer. Participants will wear the pedometer clipped to their right lateral waistband for 24 hours per day for 7 consecutive days (except during shower or water activities) to obtain 5 complete days of physical activity data. The data reported is the averaged data for session 8 of the intervention for each participant, among those who stayed in the study for all sessions.
Measured: at approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Aug 2019
- Primary completion7 Nov 2022
- Study completion6 Dec 2022
Why it stopped: Study was terminated due to poor recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will assess the feasibility of a tele-delivered behavioral change intervention among older adults (aged 50 and older) with cLBP and depression. Fifty participants will be randomly assigned to one of two groups, behavioral intervention arm (n=25) versus the waitlist control arm (n=25).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Una Makris, University of Texas Southwestern Medical Center
- Investigators
- Una Makris, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914469
- Sponsor's protocol ID
- STU 2018-0084
- Status last verified
- Feb 2025
- First submitted
- 1 Apr 2019
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOTIVATE: Moving to Improve Chronic Back Pain and Depression in Older Adults
- ClinicalTrials.gov ID
- NCT03914469
- Acronym / sponsor ID
- STU 2018-0084
- Conditions
- Back Pain Lower Back Chronic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to poor recruitment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 12 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this study is to evaluate a tele-based behavioral change intervention for older adults (aged 50 years and older) with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related disability and depressive symptoms.
Investigators will conduct a pilot randomized control trial to assess feasibility for older adults with chronic low back pain and depression to receive a behavioral change tele-based intervention delivered by a health coach trained in motivational interviewing. All participants, regardless of intervention arm assigned, will undergo outcomes assessments (baseline, mid-point, final assessments) conducted by a blinded research assistant.
Detailed description
Investigators will assess the feasibility of a tele-delivered behavioral change intervention among older adults (aged 50 and older) with chronic low back pain and depression. Fifty participants will be randomly assigned to one of two groups, behavioral intervention arm (n=25) versus the waitlist control arm (n=25). The active intervention will include eight tele-delivered health coach sessions, three tele-based outcome assessments, and up to two semi-structured interviews within 6 months of completion, post-intervention. Each tele-based outcome assessment is roughly 45-60 minutes and will be conducted by a member of the research team. Each intervention session will be delivered by a trained health coach over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).
The first session will introduce the participant to the health coach and the program, establish rapport, and measure baseline physical activity. The following six sessions address behavioral determinants, followed by a final session designed to be a booster session to the overall program.
An Omron pedometer will be provided to each participant for the assessment of physical activity. The Omron pedometer will be set up by a member of the research team (e.g., stride length, setting date/time) and will be mailed to the participant's home address between sessions one and two. Each participant will receive a courtesy phone call when the pedometer is mailed and will be asked to call the research coordinator when it arrives. The research team will provide technical assistance and instructions to the participant regarding use. The pedometer is intended to be worn on the waist band, daily, with the exception of times when the participant may shower or bathe. The research team will verbally instruct the participant on how to press the mode and memory buttons in order to provide weekly step counts for tracking physical activity. The participants will be prompted by the health coach or research staff to report step counts during subsequent weekly tele-based coaching sessions.
Since the investigators are interested in better understanding feasibility of the intervention as compared to the waitlist control, and how behaviors are sustained over time, the study involves follow-up to 6 months. Investigators will use these follow-up data to better understand differential attrition as well as preliminary formative implementation evaluation. Using purposive sampling, investigators will conduct ~ 10 in-depth semi-structured interviews. Each interview will occur ~six months post-intervention and will include key stakeholders from the following groups: study participants from each arm of the pilot study, the health coach, primary care and mental health providers.
The research staff will select participants identified as higher risk for drop-out, less engaged, or were particularly successful at achieving behavioral change. The purpose of the final interviews is to learn about the barriers and facilitators to successful intervention delivery and participant retention from the perspectives of the enrolled patients, health coach, and providers. Interview topics will borrow from components of the well-established framework, Promoting Action on Research Implementation in Health Services (PARiHS). Semi-structured interview strategy is informed by two Promoting Action on Research Implementation in Health Services (PARiHS) dimensions: context-how the microsystem (UTSW) impacts behavioral change uptake, for example, potential facilitators to intervention implementation; facilitation-identifying specific ways to augment the likelihood of implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Investigators will assess the feasibility of a tele-delivered behavioral change intervention among older adults (aged 50 and older) with cLBP and depression. Fifty participants will be randomly assigned to one of two groups, behavioral intervention arm (n=25) versus the waitlist control arm (n=25).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Behavioral Intervention GroupFor 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 50 and older
- English- speaking
- Working telephone
- Capable of participating in home-based activity
- Chronic low back pain with intensity of 4 or higher on 10 point scale
Key exclusion criteria (10 listed)
- Aged 49 or less
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Intervention GroupThe active intervention will include eight tele-delivered health coach sessions, three tele-based outcome assessments, and up to two semi-structured interviews at 6 months post-intervention. Each tele-based outcome assessment is roughly 45-60 minutes and will be conducted by a member of the research team. Each intervention session will be delivered by a trained health coach over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). | Behavioural | Behavioral Intervention Group |
Primary outcome
Recruitment Rates
Time frame: Through study completion, up to 6 months
Of patients pre-screened, the total number enrolled into the study
Rate of Intervention Completion
Time frame: Through study completion, up to 6 months
Of patients randomized into the intervention arm, the total number retained for follow-up
4 secondary outcomes
Pain Scale
Time frame: at approximately 4 months
Roland Morris Disability Questionnaire (RMDQ)
Time frame: at approximately 4 months
Depression
Time frame: at approximately 4 months
Step Counts
Time frame: at approximately 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Una Makris, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention Group in people with Back Pain Lower Back Chronic, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: Through study completion, up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.