Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for Treatment Seeking | Experimental | CBT delivered over the course of 1, ~45 minute session delivered via telehealth. |
|
| Pain Treatment Education | Active Comparator | Pain treatment education is delivered over the course of 1, ~45 minute session delivered via telehealth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy for Treatment Seeking | Behavioral | CBT delivered over the course of 1, ~45 minute sessions delivered via telehealth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medical Record Review and Treatment Utilization Form | 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. | 6-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Treatment Willingness Scale (PTWS) | 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. | 6-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Profile-29 Pain Interference | 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. | 6-months post-treatment |
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisham Ashrafioun, PhD | VA Finger Lakes Healthcare System, Canandaigua, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Finger Lakes Healthcare System, Canandaigua, NY | Canandaigua | New York | 14424-1159 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CBT for Treatment Seeking | CBT delivered over the course of 1, ~45 minute session delivered via telehealth. |
| FG001 | Pain Treatment Education | Pain treatment education is delivered over the course of 1, ~45 minute session delivered via telehealth |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CBT for Treatment Seeking | CBT delivered over the course of 1, ~45 minute session delivered via telehealth. |
| BG001 | Pain Treatment Education | Pain treatment education is delivered over the course of 1, ~45 minute session delivered via telehealth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | data missing for 6 participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medical Record Review and Treatment Utilization Form | 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. | Posted | Count of Participants | Participants | 6-months post-treatment |
|
Baseline to 6 month post treatment follow-up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT for Treatment Seeking | CBT delivered over the course of 1, ~45 minute session delivered via telehealth. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac issues | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Outpatient procedure | Surgical and medical procedures | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisham Ashrafioun | VA Center of Excellence for Suicide Prevention | 585-430-2026 | lisham.ashrafioun@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2023 | Mar 23, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2023 | May 8, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Participants are randomized to one of two interventions.
Not provided
Not provided
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.
|
| Pain treatment education | Behavioral | 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 |
|
| Medication Beliefs Questionnaire | 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. | 6-months post-treatment |
| Beck Hopelessness Scale (BHS) | 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. | 6-months post-treatment |
| Pain Catastrophizing Scale (PCS) | 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. | 6-months post-treatment |
| Tampa Scale for Kinesiophobia-17 (TSK-17) | 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. | 6-months post-treatment |
| BG002 | Total | Total of all reporting groups |
Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | data missing for 6 participants | Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent. | Count of Participants | Participants |
|
| Race (NIH/OMB) | data missing for 6 participants | Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | data missing for 7 participants | Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent. | Count of Participants | Participants |
|
| PROMIS Pain interference | Data from the PROMIS Pain Interference scale was used to assess pain-related interference in various life domains. Scores range from 4 to 20 with higher scores are indicative of higher pain interference. Data missing for 7 participants | Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent. | Mean | Standard Deviation | units on scale |
|
| Pain Catastrophizing Scale | We used the Pain Catastrophizing Scale to assess pain catastrophizing. Each of the 13 items are rated on a 5-point rating scale. Scores range from 0 to 52 with higher scores indicating higher pain catastrophizing. Data missing for 7 participants | Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent. | Mean | Standard Deviation | Units on a scale |
|
| Pain Treatment Willingness Scale | We used the 7-item Pain Treatment Willingness 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. Data missing for 7 participants | Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent. | Mean | Standard Deviation | Units on a scale |
|
| Tampa Scale of Kinesiophobia | We used the 17-item Tampa Scale of Kinesiophobia to assess pain-related fear of movement. Scores range from 17 to 68 with higher scores indicating greater kinesiophobia. | Baseline characteristics not assessed in 7 participants because they were lost to follow-up after consent. | Mean | Standard Deviation | Units on a scale |
|
| Medication Beliefs Questionnaire | 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. | Numbers differ from participant flow because of missing data. | Mean | Standard Deviation | Units on a scale |
|
| Beck Hopelessness Scale | 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. | Data missing for 8 participants. | Mean | Standard Deviation | Units on a scale |
|
|
|
|
| Secondary | Pain Treatment Willingness Scale (PTWS) | 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. | Participants analyzed differs from participant flow due to missing data. | Posted | Mean | Standard Deviation | score on a scale | 6-months post-treatment |
|
|
|
|
| Secondary | Medication Beliefs Questionnaire | 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. | Participants analyzed differs from participant flow due to missing data. | Posted | Mean | Standard Deviation | scores on a scale | 6-months post-treatment |
|
|
|
|
| Secondary | Beck Hopelessness Scale (BHS) | 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. | Participants analyzed differs from participant flow due to missing data. | Posted | Mean | Standard Deviation | scores on a scale | 6-months post-treatment |
|
|
|
|
| Secondary | Pain Catastrophizing Scale (PCS) | 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. | Participants analyzed differs from participant flow due to missing data. | Posted | Mean | Standard Deviation | scores on a scale | 6-months post-treatment |
|
|
|
|
| Secondary | Tampa Scale for Kinesiophobia-17 (TSK-17) | 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. | Participants analyzed differs from participant flow due to missing data. | Posted | Mean | Standard Deviation | scores on a scale | 6-months post-treatment |
|
|
|
|
| Other Pre-specified | PROMIS Profile-29 Pain Interference | 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. | Participants analyzed differs from participant flow due to missing data. | Posted | Mean | Standard Deviation | scores on a scale | 6-months post-treatment |
|
|
|
|
| 1 |
| 151 |
| 10 |
| 151 |
| 28 |
| 151 |
| EG001 | Pain Treatment Education | Pain treatment education is delivered over the course of 1, ~45 minute session delivered via telehealth | 0 | 149 | 12 | 149 | 28 | 149 |
| Surgery/procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Gastrointestinal issues | Gastrointestinal disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Car accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Leukemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hospitalization associated with respiratory issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization associated with renal functioning | Renal and urinary disorders | Non-systematic Assessment |
|
| Weakness, achiness, general pain | General disorders | Non-systematic Assessment |
|
| Abdominal or other pain related to GI system | Gastrointestinal disorders | Non-systematic Assessment |
|
| Emergency department visit related to skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Infections | Infections and infestations | Non-systematic Assessment |
|
| Fall or accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Emergency department visit related to color of urine | Renal and urinary disorders | Non-systematic Assessment |
|
| Emergency department visit for headaches | Nervous system disorders | Non-systematic Assessment |
|
| Psychiatric distress | Psychiatric disorders | Non-systematic Assessment |
|
| Emergency department visit related to reproductive organs | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Emergency department visit related to respiratory issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Emergency department visit due to visual impairment | Eye disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|