Trial Outcomes & Findings for Treatment, Pain, and Opioids (NCT NCT05363176)
NCT ID: NCT05363176
Last Updated: 2026-05-29
Results Overview
This will capture treatment initiation (attending at least one appointment). Treatment includes non-pharmacological pain treatments (e.g., psychosocial interventions, movement-related interventions.) This was captured through medical record chart review. The investigators calculated percent who initiated treatment by the 6 month follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
6-months post-treatment
Results posted on
2026-05-29
Participant Flow
Participant milestones
| Measure |
CBT for Treatment Seeking
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
149
|
|
Overall Study
COMPLETED
|
129
|
136
|
|
Overall Study
NOT COMPLETED
|
22
|
13
|
Reasons for withdrawal
| Measure |
CBT for Treatment Seeking
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
8
|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
Baseline Characteristics
Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
Baseline characteristics by cohort
| Measure |
CBT for Treatment Seeking
n=146 Participants
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=148 Participants
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.73 Years
STANDARD_DEVIATION 10.83 • n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
65.20 Years
STANDARD_DEVIATION 9.51 • n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
63.97 Years
STANDARD_DEVIATION 10.24 • n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Sex: Female, Male
Female
|
22 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
21 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
43 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Sex: Female, Male
Male
|
124 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
127 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
251 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
1 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
3 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
0 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
1 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
0 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
0 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
52 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
103 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Race (NIH/OMB)
White
|
85 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
83 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
168 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
8 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
10 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=146 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
4 Participants
n=148 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
9 Participants
n=294 Participants • Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=146 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
12 Participants
n=147 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
19 Participants
n=293 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=146 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
135 Participants
n=147 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
274 Participants
n=293 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=146 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
0 Participants
n=147 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
0 Participants
n=293 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
|
PROMIS Pain interference
|
15.61 units on scale
STANDARD_DEVIATION 3.68 • n=146 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
14.8 units on scale
STANDARD_DEVIATION 4.21 • n=147 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
15.2 units on scale
STANDARD_DEVIATION 3.97 • n=293 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
|
Pain Catastrophizing Scale
|
22.39 Units on a scale
STANDARD_DEVIATION 12.44 • n=146 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
22.47 Units on a scale
STANDARD_DEVIATION 12.43 • n=147 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
22.43 Units on a scale
STANDARD_DEVIATION 12.41 • n=293 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
|
Pain Treatment Willingness Scale
|
3.68 Units on a scale
STANDARD_DEVIATION 1.19 • n=146 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
3.59 Units on a scale
STANDARD_DEVIATION 1.12 • n=147 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
3.63 Units on a scale
STANDARD_DEVIATION 1.15 • n=293 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
|
Tampa Scale of Kinesiophobia
|
30.31 Units on a scale
STANDARD_DEVIATION 5.74 • n=146 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
30.73 Units on a scale
STANDARD_DEVIATION 5.85 • n=147 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
30.52 Units on a scale
STANDARD_DEVIATION 5.79 • n=293 Participants • Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent.
|
|
Medication Beliefs Questionnaire
|
16.2 Units on a scale
STANDARD_DEVIATION 2.76 • n=146 Participants • Numbers differ from participant flow because of missing data.
|
16.49 Units on a scale
STANDARD_DEVIATION 2.86 • n=146 Participants • Numbers differ from participant flow because of missing data.
|
16.35 Units on a scale
STANDARD_DEVIATION 2.81 • n=292 Participants • Numbers differ from participant flow because of missing data.
|
|
Beck Hopelessness Scale
|
5.04 Units on a scale
STANDARD_DEVIATION 4.79 • n=145 Participants • Data missing for 8 participants.
|
4.97 Units on a scale
STANDARD_DEVIATION 5.1 • n=147 Participants • Data missing for 8 participants.
|
5.01 Units on a scale
STANDARD_DEVIATION 4.94 • n=292 Participants • Data missing for 8 participants.
|
PRIMARY outcome
Timeframe: 6-months post-treatmentThis will capture treatment initiation (attending at least one appointment). Treatment includes non-pharmacological pain treatments (e.g., psychosocial interventions, movement-related interventions.) This was captured through medical record chart review. The investigators calculated percent who initiated treatment by the 6 month follow-up.
Outcome measures
| Measure |
CBT for Treatment Seeking
n=129 Participants
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=136 Participants
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Medical Record Review and Treatment Utilization Form
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6-months post-treatmentPopulation: Participants analyzed differs from participant flow due to missing data.
Beliefs about psychosocial and other non-pharmacological pain treatments will be assessed using a modified PTWS, a 7-item scale to assess willingness to try various pain treatments. Scores range from 0 to 6 (averaged across items) with 6 indicating greater willingness to engage in the treatment.
Outcome measures
| Measure |
CBT for Treatment Seeking
n=114 Participants
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=117 Participants
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Pain Treatment Willingness Scale (PTWS)
|
3.7 score on a scale
Standard Deviation 1.31
|
3.61 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 6-months post-treatmentPopulation: Participants analyzed differs from participant flow due to missing data.
The Medication Beliefs Questionnaire uses five items to assess beliefs about one's response to, relief from, and potential for addiction to opioid analgesics. Respondents are asked to select one of five responses for each item (e.g., "None at all" to "Complete", "Much worse" to "Much better"). Scores range from 0 to 20 with higher scores indicating greater endorsement of beliefs.
Outcome measures
| Measure |
CBT for Treatment Seeking
n=116 Participants
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=114 Participants
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Medication Beliefs Questionnaire
|
15.97 scores on a scale
Standard Deviation 2.84
|
15.97 scores on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: 6-months post-treatmentPopulation: Participants analyzed differs from participant flow due to missing data.
The Beck Hopelessness Scale contains 20 true-false items designed to assess beliefs about the future. Scores range from 0-20. Higher scores represents greater hopelessness.
Outcome measures
| Measure |
CBT for Treatment Seeking
n=114 Participants
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=117 Participants
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Beck Hopelessness Scale (BHS)
|
4.82 scores on a scale
Standard Deviation 5.17
|
5.04 scores on a scale
Standard Deviation 5.73
|
SECONDARY outcome
Timeframe: 6-months post-treatmentPopulation: Participants analyzed differs from participant flow due to missing data.
The PCS is a 13-item measure, with each item rated on a 5-point rating scale to assess pain catastrophizing. Scores range from 0 to 52 with higher scores indicating higher pain catastrophizing.
Outcome measures
| Measure |
CBT for Treatment Seeking
n=114 Participants
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=116 Participants
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
|
21.12 scores on a scale
Standard Deviation 12.57
|
20.9 scores on a scale
Standard Deviation 14.57
|
SECONDARY outcome
Timeframe: 6-months post-treatmentPopulation: Participants analyzed differs from participant flow due to missing data.
The TSK-11 is an 17-item measure assessing pain-related fear of movement or injury. Scores range from 17 to 68 with higher scores indicating greater kinesiophobia.
Outcome measures
| Measure |
CBT for Treatment Seeking
n=114 Participants
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=117 Participants
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Tampa Scale for Kinesiophobia-17 (TSK-17)
|
44.36 scores on a scale
Standard Deviation 7.52
|
44.16 scores on a scale
Standard Deviation 7.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-months post-treatmentPopulation: Participants analyzed differs from participant flow due to missing data.
The PROMIS-29 provides a profile of one's health-related quality of life, in various life domains, including pain interference. Scores range from 4 to 20 with higher scores are indicative of higher pain interference.
Outcome measures
| Measure |
CBT for Treatment Seeking
n=114 Participants
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=117 Participants
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
PROMIS Profile-29 Pain Interference
|
15 scores on a scale
Standard Deviation 4.07
|
14.59 scores on a scale
Standard Deviation 4.19
|
Adverse Events
CBT for Treatment Seeking
Serious events: 10 serious events
Other events: 28 other events
Deaths: 1 deaths
Pain Treatment Education
Serious events: 12 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CBT for Treatment Seeking
n=151 participants at risk
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=149 participants at risk
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Cardiac disorders
cardiac issues
|
1.3%
2/151 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
0.67%
1/149 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
|
Surgical and medical procedures
Surgery/procedure
|
2.0%
3/151 • Number of events 3 • Baseline to 6 month post treatment follow-up
|
1.3%
2/149 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
|
Nervous system disorders
Encephalopathy
|
0.66%
1/151 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
0.00%
0/149 • Baseline to 6 month post treatment follow-up
|
|
General disorders
Fatigue
|
0.66%
1/151 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
0.67%
1/149 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
|
Gastrointestinal disorders
Gastrointestinal issues
|
0.66%
1/151 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
0.67%
1/149 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.66%
1/151 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
1.3%
2/149 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
|
Injury, poisoning and procedural complications
Car accident
|
0.66%
1/151 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
0.00%
0/149 • Baseline to 6 month post treatment follow-up
|
|
Blood and lymphatic system disorders
Leukemia
|
0.00%
0/151 • Baseline to 6 month post treatment follow-up
|
0.67%
1/149 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization associated with respiratory issues
|
0.00%
0/151 • Baseline to 6 month post treatment follow-up
|
2.7%
4/149 • Baseline to 6 month post treatment follow-up
|
|
Renal and urinary disorders
Hospitalization associated with renal functioning
|
0.00%
0/151 • Baseline to 6 month post treatment follow-up
|
1.3%
2/149 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
Other adverse events
| Measure |
CBT for Treatment Seeking
n=151 participants at risk
CBT delivered over the course of 1, \~45 minute session delivered via telehealth.
|
Pain Treatment Education
n=149 participants at risk
Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth
|
|---|---|---|
|
Eye disorders
Emergency department visit due to visual impairment
|
0.00%
0/151 • Baseline to 6 month post treatment follow-up
|
0.67%
1/149 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Emergency department visit related to respiratory issues
|
5.3%
8/151 • Number of events 8 • Baseline to 6 month post treatment follow-up
|
3.4%
5/149 • Number of events 6 • Baseline to 6 month post treatment follow-up
|
|
Surgical and medical procedures
Outpatient procedure
|
4.0%
6/151 • Number of events 6 • Baseline to 6 month post treatment follow-up
|
1.3%
2/149 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
|
General disorders
Weakness, achiness, general pain
|
1.3%
2/151 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
0.00%
0/149 • Baseline to 6 month post treatment follow-up
|
|
Gastrointestinal disorders
Abdominal or other pain related to GI system
|
4.0%
6/151 • Number of events 6 • Baseline to 6 month post treatment follow-up
|
0.67%
1/149 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
|
Skin and subcutaneous tissue disorders
Emergency department visit related to skin
|
1.3%
2/151 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
2.0%
3/149 • Number of events 3 • Baseline to 6 month post treatment follow-up
|
|
Infections and infestations
Infections
|
2.0%
3/151 • Number of events 4 • Baseline to 6 month post treatment follow-up
|
2.7%
4/149 • Number of events 4 • Baseline to 6 month post treatment follow-up
|
|
Injury, poisoning and procedural complications
Fall or accident
|
1.3%
2/151 • Number of events 3 • Baseline to 6 month post treatment follow-up
|
2.0%
3/149 • Number of events 3 • Baseline to 6 month post treatment follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
5/151 • Number of events 8 • Baseline to 6 month post treatment follow-up
|
6.0%
9/149 • Number of events 9 • Baseline to 6 month post treatment follow-up
|
|
Renal and urinary disorders
Emergency department visit related to color of urine
|
0.66%
1/151 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
0.00%
0/149 • Baseline to 6 month post treatment follow-up
|
|
Nervous system disorders
Emergency department visit for headaches
|
1.3%
2/151 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
0.00%
0/149 • Baseline to 6 month post treatment follow-up
|
|
Psychiatric disorders
Psychiatric distress
|
1.3%
2/151 • Number of events 3 • Baseline to 6 month post treatment follow-up
|
4.7%
7/149 • Number of events 7 • Baseline to 6 month post treatment follow-up
|
|
Reproductive system and breast disorders
Emergency department visit related to reproductive organs
|
1.3%
2/151 • Number of events 2 • Baseline to 6 month post treatment follow-up
|
0.67%
1/149 • Number of events 1 • Baseline to 6 month post treatment follow-up
|
Additional Information
Lisham Ashrafioun
VA Center of Excellence for Suicide Prevention
Phone: 585-430-2026
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place