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.

MOTIVATE: Moving to Improve Outcomes for Older Adults

Back Pain Lower Back Chronic

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.

Behavioral Intervention Group

MOTIVATE: Moving to Improve Chronic Back Pain and Depression in Older Adults

Of patients pre-screened, the total number enrolled into the study

Of patients randomized into the intervention arm, the total number retained for follow-up

Principal Investigator

Pain intensity on 0-10 scale where higher values are worse pain

Disability related to back pain. Scale ranges from 0-24 with larger numbers indicating worse disability related to chronic back pain.

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

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 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.

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.

MOTIVATE: Moving to Improve Outcomes for Older Adults

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?