N/A
N=302
Back on Track to Healthy Living Study
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03687762 ↗Enrolled (actual)
302
Serious AEs
8.3%
Results posted
Mar 2025
Primary outcome: Primary: Change in Pain Interference (Micro-level Change) — -1.34; -1.03; -0.50; -0.73 scores on a scale — p=>.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Therapy (CT) (Behavioral); Mindfulness Meditation (MM) (Behavioral); Behavioral Activation (BA) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Interference (Micro-level Change) |
-1.34; -1.03; -0.50; -0.73; 0.01; -0.73 | >.05 |
| PRIMARY Change in Pain Interference (Macro-level Change) |
-5.0; -4.5; -5.6; -4.7; -3.4; -5.6 | >.05 |
| SECONDARY Change in Pain Intensity (Micro-level) |
-0.40; -0.26; -0.23; -0.17; 0.09; -0.04 | >.05 |
| SECONDARY Change in Mood (Micro-level) |
0.13; 0.06; 0.01; -0.19; -0.08; -0.13 | >.05 |
| SECONDARY Change in Physical Function |
1.6; 1.1; 2.1; 2.0; 1.2; 2.7 | >.05 |
| SECONDARY Change in Sleep Quality |
-3.5; -1.7; -4.9; -3.5; -2.1; -4.3 | 0.01 sig |
| SECONDARY Change in Depression Severity |
-3.3; -2.6; -2.6; -2.4; -2.3; -2.0 | >.05 |
| SECONDARY Change in Anxiety Severity |
-2.2; -2.1; -1.5; -1.4; -2.2; -0.4 | >.05 |
| SECONDARY Change in Medication Use |
58; 61; 58; 53; 53; 49 | >.05 |
| SECONDARY Change in Pain Intensity (Macro-level) |
-1.0; -1.2; -1.3; -0.9; -0.8; -1.4 | >.05 |
| SECONDARY Change in Mood (Macro-level) |
1.5; 1.3; 1.6; -1.2; -0.8; -1.3 | >.05 |
Summary
Chronic pain is a significant problem affecting millions of Americans. Research has shown that psychological treatments can help people with chronic pain manage their pain and improve their quality of life. Three common psychological treatments for chronic pain are Cognitive Therapy (CT), Mindfulness Meditation (MM), and Behavioral Activation (BA). While research has shown these treatments are helpful for people with chronic pain, there is little research explaining why these treatments are helpful. The purpose of this study is to understand the specific ways these treatments work. Increasing our understanding of how these treatments work will help researchers and clinicians improve treatments for people with chronic pain in the future. As a secondary aim, this study will also examine the post-treatment mechanisms that explain relapse, maintenance, and continued gains associated with these treatments. Treatment moderators will also be explored.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years;
- Endorse having low back pain as a primary or secondary pain problem in the past 6 months;
- Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months);
- Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months;
- Chronic pain interference for general activities ≥3 on a 10-point scale for the past 3 months;
- Able to read, speak, and understand English;
- If currently taking analgesic or psychotropic medication, medications must have been stabilized for ≥4 weeks prior to this study; and
- Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access.
Exclusion Criteria
- Primary pain condition is headache;
- Severe cognitive impairment;
- Current alcohol or substance dependence;
- Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus);
- Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention;
- Significant pain from a recent surgery or injury;
- Pain condition for which surgery has been recommended and is planned;
- Any planned surgery, procedure, or hospitalization that may conflict with or otherwise influence participation in the study;
- Currently receiving or had received other psychosocial treatments for any pain condition;
- Current or past participation in a research study with treatment components that may overlap those in the current study;
- Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
- Psychiatric hospitalization within the past 6 months;
- Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months;
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT03687762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.