Back on Track to Healthy Living Study

The purpose of this randomized controlled trial is to evaluate the mechanisms of cognitive
therapy (CT), mindfulness meditation (MM), and activation skills (AS) as treatments for
chronic low back pain (CLBP) in a sample of 240 individuals. Participants will be randomly
assigned to eight (8), 1.5 hour telehealth group sessions of (1) CT, (2) MM, or (3) AS.
Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment
period, and 4-week post-treatment epoch via cue-elicited ecological momentary assessment
(EMA); activity level will be monitored during these time epochs via daily monitoring with
ActiGraph technology. Follow-up macro-level assessments will be conducted at 3- and 6-months
post-treatment. The study will address two aims.

Primary Objective: The objective of the proposed research is to examine the mechanisms of
cognitive therapy (CT), mindfulness meditation training (MM), and activation skills treatment
(AS) [Aim 1; Primary]. After ensuring that there is at least a small effect of time on early
treatment changes in the three mechanism variables, researchers will determine the extent to
which late-treatment improvement in primary outcome (pain interference) associated with CT,
MM, and AS is predicted by early-treatment changes in cognitive content (i.e., pain
catastrophizing), cognitive process (i.e., non-judgment), and/or activity level (i.e.,
ActiGraph "activity counts").

Hypothesis 1a: Early treatment changes in pain catastrophizing, non-judgment, and activity
counts are significantly associated with late treatment improvements in pain interference.

Hypothesis 1b: The Shared Mechanisms Model hypothesizes that if changes in cognitive content,
cognitive process, and activity levels are shared mechanisms across the three treatments,
then treatment condition will have small and non-significant effects on early changes in the
mechanism variables (i.e., the effects of the three treatments on the three mechanism
variables will be similar; Shared Mechanisms Model).

Hypothesis 1c: The Specific Mechanisms Model hypothesizes that if changes in content,
process, and activity level are mechanisms specific to CT, MM, and AS, respectively, then
treatment condition will have a significant effect on early changes in the mechanism
variables (i.e., the effects of the three treatments on the three mechanism variables will be
different, with CT having the largest effects on early treatment decreases in
catastrophizing, MM having the largest effects on early treatment increases in non-judgment,
and AS having the largest effects on early treatment increases in activity level). Further,
later improvement in the primary outcome will be predicted by different mechanism variables
as a function of treatment condition; that is, late treatment changes in pain interference
will be substantially and uniquely predicted by early treatment changes in: (1) cognitive
content (i.e., pain catastrophizing) in CT but not in MM or AS; (2) cognitive process (i.e.,
non-judgment) in MM but not in CT or AS; and (3) activity level in AS but not in CT or MM, in
addition to each mechanism variable significantly predicting the primary outcome (Specific
Mechanisms Model).

Researchers also predict that change in the mechanism variables will precede and predict
change in outcome, but not vice versa.

Secondary Objective: As a secondary aim, this study will also evaluate the post-treatment
mechanisms that explain relapse, maintenance, and continued gains associated with these
treatments [Aim 2; Secondary]. The Shared (Hypothesis 2a) and Specific (Hypothesis 2b)
Mechanism models will also be applied to data collected via EMA and ActiGraph daily during
the 4-weeks post-treatment to better understand the post-treatment mechanisms that underlie
maintenance of gains and relapse.

Exploratory Objective: Test the Limit, Activate, and Enhance (LAE) moderation model.
Specifically, to test if (1) higher baseline levels of catastrophizing are associated with a
positive response to the CT intervention, (2) lower baseline levels of activity are
associated with a positive response to AS, and (3) higher baseline levels of non-judgment are
associated with a positive response to MM.

Primary and Secondary Endpoint: The primary endpoint researchers propose for the primary
study aim (Aim 1) is the post-treatment pain interference score, operationalized as an
average of pain interference ratings made on the twice-daily diaries during the first four
days after treatment (i.e., Days 43-46). The endpoint for the secondary study aim (Aim 2) is
the post-treatment score at 28 days follow-up, as operationalized as the average of days
67-70 of pain interference ratings on the diaries.

Design and Outcomes

A randomized, 3-group parallel design, 240-subject clinical trial to test the mechanisms of
cognitive therapy, mindfulness meditation, and activation skills on individuals with chronic
low back pain.

Interventions and Duration

Participants will be randomly assigned to eight (8) telehealth group sessions of (1)
cognitive therapy (CT), (2) mindfulness meditation (MM), or (3) activation skills (AS).
Treatment groups will meet, on average, twice per week over the Zoom videoconferencing
platform. Each session will last for a duration of about 90 minutes. Proposed mechanisms and
outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and
4-week post-treatment epoch via cue-elicited ecological momentary assessment (EMA); activity
level will be monitored during these time epochs via daily monitoring with ActiGraph
technology. Macro-level assessments will be conducted at pre- and post-treatment and at 3-
and 6-months post-treatment.

The total time involved in the study (excluding between session skills practice) is
approximately 35-40 hours over an 8 to 9-month period.

Sample Size and Population

Researchers plan to enroll 300 participants with moderate to severe chronic low back pain to
achieve a sample size of 240 completers, with 80 completers in each of the treatment groups.

Enrolled participants who complete the required baseline components (baseline data and
demographic questions, pre-treatment extended assessment period, technology training,
re-assessment of low back pain interference for general activities with a score of ≥3 for the
past 3 months, a minimum number of EMA surveys during one week of Baseline Monitoring (Days
1-7), and returning their ActiGraph after one week of ActiGraph Compliance Monitoring with
overall wear compliance at 70% of time or higher) will be randomized in stratified blocks to
ensure that participants with each sex and pain interference level (mild/moderate or severe)
have an equal chance of being randomized to one of the three conditions. Stratifying in this
manner will ensure the groups are balanced to reduce variation in outcome that is associated
with each stratification variable.

Inclusion Criteria:

1. Age ≥18 years;

2. Diagnosis of low back pain;

3. Location of primary (i.e., worst) pain source is the low back region;

4. Chronic (≥3 months, with pain experienced on ≥50% of days) musculoskeletal pain of the
lower back;

5. Average intensity of low back pain ≥3 on a 10-point scale for most days of the
previous 3 months;

6. Low back pain interference for general activities ≥3 on a 10-point scale for the past
3 months;

7. Able to read, speak, and understand English;

8. If currently taking analgesic or psychotropic medication, medications must have been
stabilized for ≥4 weeks prior to this study; and

9. Availability of a telephone, webcam and microphone through computer or telephone, as
well as daily internet access.

Exclusion Criteria:

1. Severe cognitive impairment;

2. Current alcohol or substance dependence;

3. Active malignancy (e.g., cancer not in remission) or autoimmune disorders with a pain
component (e.g., lupus);

4. Another confounding chronic pain condition that interacts with or complicates one's
low back pain, causing the low back pain to be qualitatively distinct from typical,
non-specific low back pain;

5. CLBP condition for which surgery is recommended and/or planned;

6. Currently receiving other psychosocial treatments for any pain condition;

7. Current or past participation in a UW Department of Rehabilitation Medicine research
study with treatment components that may overlap those in the current study;

8. Current or history of diagnosis of primary psychotic or major thought disorder within
the past 5 years;

9. Psychiatric hospitalization within the past 6 months;

10. Psychiatric or behavioral conditions in which symptoms were unstable or severe within
the past 6 months;

11. Any psychiatric or behavioral issues as noted in the medical record or
disclosed/observed during self-report screening that would indicate participant may be
inappropriate in a group setting; and

12. Presenting symptoms at the time of screening that would interfere with participation,
specifically active suicidal or homicidal ideation with intent to harm oneself or
others or active delusional or psychotic thinking.