Treatment, Pain, and Opioids
Primary Purpose
Chronic Pain
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy for Treatment Seeking
Pain treatment education
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Prescription opioids, Treatment, Treatment engagement, Beliefs
Eligibility Criteria
Inclusion Criteria:
- Participants will include English-speaking Veterans on long-term opioid therapy prescribed opioid analgesics (>20mg morphine equivalent daily [MEDD] and at least a 90 days supply).
Participants must report pain that occurs on at least half the days for six months.
- They must score at least a 4 on each item of the three items on a brief pain intensity and interference measure.
Exclusion Criteria:
- Veterans will be excluded if they are currently undergoing oncology treatment, are hospice patients, and have a recent or upcoming surgery.
- Veterans will be excluded if they are currently engaged (i.e., within the past month) in non-pharmacological pain treatment.
Sites / Locations
- VA Finger Lakes Healthcare System, Canandaigua, NY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT for Treatment Seeking
Pain Treatment Education
Arm Description
CBT delivered over the course of 1, ~45 minute session delivered via telehealth.
Pain treatment education is delivered over the course of 1, ~45 minute session delivered via telehealth
Outcomes
Primary Outcome Measures
Medical Record Review and Treatment Utilization Form
This will capture treatment initiation and treatment retention information including treatment types, dates of service, number of sessions, and type and dose of VHA and non-VHA medications dispensed.
Secondary Outcome Measures
Pain Treatment Willingness Scale (PTWS)
Beliefs about psychosocial and other non-pharmacological pain treatments will be assessed using a modified PTWS. The scale consists of seven items assessing respondents' willingness to use opioids or non-pharmacological approaches using a 6-point rating scale. (1 = "not at all willing" to 6 "extremely willing").
Medication Beliefs Questionnaire
The MBQ 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").
Beck Hopelessness Scale (BHS)
The BHS contains 20 true-false items designed to assess beliefs about the future. Higher scores represents greater hopelessness.
Pain Catastrophizing Scale
The PCS is a 13-item measure, with each item rated on a 5-point rating scale (0 = "Not at all" to 4 = "All the time"). Higher scores represent more rumination, magnification, and helplessness over pain.
Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ is an 11-item measure that assesses one's confidence in performing activities while in pain.
Tampa Scale for Kinesiophobia-11 (TSK-11)
The TSK-11 is an 11-item measure assessing pain-related fear of movement or injury with higher scores representing greater fear of movement.
Full Information
NCT ID
NCT05363176
First Posted
May 2, 2022
Last Updated
May 26, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05363176
Brief Title
Treatment, Pain, and Opioids
Official Title
Telehealth CBT to Increase Engagement in Pain Treatment Among Veterans Using Prescription Opioids
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Chronic pain and negative consequences of long-term opioid therapy are related public health concerns associated with significant functional impairment, high psychiatric comorbidity, and premature mortality, particularly among Veterans. Clinical Practice Guidelines for opioid prescribing and pain management recommend using non-pharmacological approaches as first-line treatments. Psychosocial interventions (e.g., cognitive-behavioral therapy) have strong evidence supporting their ability to improve pain outcomes. Patient beliefs about the stigma associated with psychological interventions, opioid analgesics, ability of psychosocial intervention to improve pain among others can greatly interfere with the patients' ability to initiate and maintain engagement in psychosocial interventions and other non-pharmacological approaches.
Significance/Impact: Without a concerted effort at affecting beliefs that impede engagement in treatment, Veterans who may benefit from the treatment, will not receive it. This can result in continued risk for negative consequences associated with long-term opioid therapy and inadequate pain management. Cognitive-Behavioral Therapy for Treatment Seeking (CBT-TS) is an evidence-based intervention that directly intervenes on beliefs that act as barriers to treatment initiation and retention. By intervening on these beliefs, this study has the potential to improve engagement in psychosocial pain interventions and other non-pharmacological pain treatments, which will improve pain-related interference and functioning and reduce reliance on opioid analgesics. This study addresses VHA/VA Veteran care priorities including opioid use, pain management, and access and directly addresses priorities of the HSR&D Targeted Solicitation for Service Directed Research on Opioid Safety and Opioid Use Disorder.
Innovation: The proposed study is the first application of CBT-TS for Veterans with chronic pain who are receiving opioid analgesics-a notably high-risk, treatment-resistant population. This is the first study to directly intervene on thoughts about psychosocial interventions.
Specific Aims: The specific aims are to: test the effects of CBT-TS to increase initiation of psychosocial interventions for pain among Veterans receiving opioid analgesics for chronic pain (Aim 1), test the effects of CBT-TS to increase the retention in psychosocial interventions for pain among Veterans receiving opioid analgesics for chronic pain (Aim 2), and evaluate the effects of CBT-TS in improving pain and substance use outcomes among Veterans receiving opioid analgesics for chronic pain (Aim 3). The investigators will also test the effects of CBT-TS on the initiation of and retention to other non-pharmacological pain treatments (Exploratory Aim).
Methodology: Participants (N = 300) will be randomized to either the CBT-TS condition or an education control condition. Participants in both conditions will complete assessments on pain, treatment engagement, and opioid use at baseline, and 1-, 3-, and 6-months post-treatment to assess primary, secondary, and exploratory outcomes.
Implementation/Next Steps: Results from this study will provide critical information on increasing engagement of psychosocial interventions for pain, which can be used to inform future implementation and dissemination efforts. The research team will work with the VHA National Pain Management and Opioid Safety office and the VHA Office of Patient Centered Care & Cultural Transformation to identify implementation and dissemination efforts. CBT-TS is undergoing current implementation research to increase mental health functioning and this effort could be expanded to also increase treatment engagement of psychosocial interventions for pain and other non-pharmacological pain treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Prescription opioids, Treatment, Treatment engagement, Beliefs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to one of two interventions.
Masking
InvestigatorOutcomes Assessor
Masking Description
The outcomes assessors will not know what condition that the participant was allocated to, nor will the statistician who is one of the co-investigators.
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT for Treatment Seeking
Arm Type
Experimental
Arm Description
CBT delivered over the course of 1, ~45 minute session delivered via telehealth.
Arm Title
Pain Treatment Education
Arm Type
Active Comparator
Arm Description
Pain treatment education is delivered over the course of 1, ~45 minute session delivered via telehealth
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy for Treatment Seeking
Other Intervention Name(s)
CBT-TS
Intervention Description
CBT delivered over the course of 1, ~45 minute sessions delivered via telehealth.
Intervention Type
Behavioral
Intervention Name(s)
Pain treatment education
Intervention Description
Pain treatment education describes a variety of pain treatments offered in the VA. It is delivered over the course of 1, ~45 minute session delivered via telehealth
Primary Outcome Measure Information:
Title
Medical Record Review and Treatment Utilization Form
Description
This will capture treatment initiation and treatment retention information including treatment types, dates of service, number of sessions, and type and dose of VHA and non-VHA medications dispensed.
Time Frame
Baseline to 6-months post-treatment
Secondary Outcome Measure Information:
Title
Pain Treatment Willingness Scale (PTWS)
Description
Beliefs about psychosocial and other non-pharmacological pain treatments will be assessed using a modified PTWS. The scale consists of seven items assessing respondents' willingness to use opioids or non-pharmacological approaches using a 6-point rating scale. (1 = "not at all willing" to 6 "extremely willing").
Time Frame
Baseline to 6-months post-treatment
Title
Medication Beliefs Questionnaire
Description
The MBQ 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").
Time Frame
Baseline to 6-months post-treatment
Title
Beck Hopelessness Scale (BHS)
Description
The BHS contains 20 true-false items designed to assess beliefs about the future. Higher scores represents greater hopelessness.
Time Frame
Baseline to 6-months post-treatment
Title
Pain Catastrophizing Scale
Description
The PCS is a 13-item measure, with each item rated on a 5-point rating scale (0 = "Not at all" to 4 = "All the time"). Higher scores represent more rumination, magnification, and helplessness over pain.
Time Frame
Baseline to 6-months post-treatment
Title
Pain Self-Efficacy Questionnaire (PSEQ)
Description
The PSEQ is an 11-item measure that assesses one's confidence in performing activities while in pain.
Time Frame
Baseline to 6-months post-treatment
Title
Tampa Scale for Kinesiophobia-11 (TSK-11)
Description
The TSK-11 is an 11-item measure assessing pain-related fear of movement or injury with higher scores representing greater fear of movement.
Time Frame
Baseline to 6-months post-treatment
Other Pre-specified Outcome Measures:
Title
PROMIS Profile-29
Description
The PROMIS-29 provides a profile of one's health-related quality of life with components including pain interference, physical functioning, sleep disturbance, social functioning, anxiety, fatigue, and depression.
Time Frame
Baseline to 6-months post-treatment
Title
Opioid use
Description
A 17-item measure will be used that assesses the frequency of aberrant drug-related behaviors and other behaviors that are prevalent among pain patients who are using prescription opioids. The rating scale ranges from 0 ("Never") to 4 ("Very Often"), with higher scores indicating greater risk.
Time Frame
Baseline to 6-months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants will include English-speaking Veterans on long-term opioid therapy prescribed opioid analgesics (>20mg morphine equivalent daily [MEDD] and at least a 90 days supply).
Participants must report pain that occurs on at least half the days for six months.
They must score at least a 4 on each item of the three items on a brief pain intensity and interference measure.
Exclusion Criteria:
Veterans will be excluded if they are currently undergoing oncology treatment, are hospice patients, and have a recent or upcoming surgery.
Veterans will be excluded if they are currently engaged (i.e., within the past month) in non-pharmacological pain treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisham Ashrafioun, PhD
Organizational Affiliation
VA Finger Lakes Healthcare System, Canandaigua, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Finger Lakes Healthcare System, Canandaigua, NY
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424-1159
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Treatment, Pain, and Opioids
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