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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03469505
Other study ID # 2000024225
Secondary ID 1UG3AT009767-014
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 27, 2019
Est. completion date February 20, 2025

Study information

Verified date March 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (CBT-CP)


Description:

Our prior efficacy trial found that COPES was not inferior to in-person CBT-CP and that participants attended, on average, a little over two more treatment weeks in COPES than in-person treatment, presumably due to the ease of in-home treatment attendance relative to in-person treatment.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 764
Est. completion date February 20, 2025
Est. primary completion date June 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with chronic musculoskeletal pain receiving care in VHA. - A pain-related musculoskeletal diagnosis indicated by an EHR identified ICD-9 or -10 code. - The presence of chronic pain of at least moderate severity with EHR NRS pain scores = 4 in three separate months for a period of 12 months. - Absence of mental illness serious enough to have resulted in an inpatient psychiatric hospitalization in the prior 3 months excluding detoxification of alcohol or drugs. - Absence of malignant cancer diagnosis or receipt of hospice or end-of-life palliative care. - Ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block and absence of diabetic foot ulcers at the time of the enrollment. - Absence of significant cognitive impairment as identified by a dementia-related diagnosis. - Availability of a touch-tone land-line or cellular telephone and no vision or hearing deficits that would impair participation verified by patient report at the time of the enrollment call. Exclusion Criteria: - Patients not fitting criteria for inclusion.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
COPES
Cooperative Pain Education and Self-Management for chronic pain therapy.
CBT-CP
Cognitive Behavioral Therapy for Chronic Pain

Locations

Country Name City State
United States VA Ann Arbor Healthcare System Ann Arbor Michigan
United States Ralph H. Johnson VA Medical Center Charleston South Carolina
United States VA North Texas Healthcare System Dallas Texas
United States Edward Hines, Jr. VA Hospital Hines Illinois
United States G.V. (Sonny) Montgomery VA Medical Center Jackson Mississippi
United States VA Central Western Massachusetts Leeds Massachusetts
United States Oklahoma City VA Health Care System Oklahoma City Oklahoma
United States VA Puget Sound Healthcare System Seattle Washington
United States VA Central Texas Healthcare System Temple Texas

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Pain Inventory The Total Brief Pain Inventory Score is a composite of patient-reported pain intensity and pain-related interference. Data will be collected through automated Interactive Voice Response (IVR) calls. 1 month
Primary Brief Pain Inventory The Total Brief Pain Inventory Score is a composite of patient-reported pain intensity and pain-related interference. Data will be collected through automated IVR calls. 3 months
Primary Brief Pain Inventory The Total Brief Pain Inventory Score is a composite of patient-reported pain intensity and pain-related interference. Data will be collected through automated IVR calls. 6 months
Primary Brief Pain Inventory The Total Brief Pain Inventory Score is a composite of patient-reported pain intensity and pain-related interference. Data will be collected through automated IVR calls. 12 months
Secondary Current Pain Intensity Rating VHA care guidelines specify that the 11-point (no pain) to (worst pain imaginable) Numeric Rating Scale (NRS) for current pain be collected at the point of care for every visit as part of the vital signs assessment. This data will be extracted from the electronic health records (EHR). 1 month
Secondary Current Pain Intensity Rating VHA care guidelines specify that the 11-point (no pain) to (worst pain imaginable) NRS for current pain be collected at the point of care for every visit as part of the vital signs assessment.This data will be extracted from the electronic health records (EHR). 3 months
Secondary Current Pain Intensity Rating VHA care guidelines specify that the 11-point (no pain) to (worst pain imaginable) NRS for current pain be collected at the point of care for every visit as part of the vital signs assessment.This data will be extracted from the electronic health records (EHR). 6 months
Secondary Current Pain Intensity Rating VHA care guidelines specify that the 11-point (no pain) to (worst pain imaginable) NRS for current pain be collected at the point of care for every visit as part of the vital signs assessment.This data will be extracted from the electronic health records (EHR). 12 months
Secondary Patient Global Perception of Change The Patient Global Perception of Change scale is a single item measure that quantifies a participant's overall perception of improvement since beginning treatment and the clinical importance of that improvement. Participants indicate improvement on a 7 point "much worse" to "much better" scale. 1 month
Secondary Patient Global Perception of Change The Patient Global Perception of Change scale is a single item measure that quantifies a participant's overall perception of improvement since beginning treatment and the clinical importance of that improvement. Participants indicate improvement on a 7 point "much worse" to "much better" scale. 3 months
Secondary Patient Global Perception of Change The Patient Global Perception of Change scale is a single item measure that quantifies a participant's overall perception of improvement since beginning treatment and the clinical importance of that improvement. Participants indicate improvement on a 7 point "much worse" to "much better" scale. 6 months
Secondary Patient Global Perception of Change The Patient Global Perception of Change scale is a single item measure that quantifies a participant's overall perception of improvement since beginning treatment and the clinical importance of that improvement. Participants indicate improvement on a 7 point "much worse" to "much better" scale. 12 months
Secondary Depression symptom severity Depression symptom severity will be assessed using the 9-item Patient Health Questionnaire (PHQ-9) a widely-used measure with excellent internal consistency and stability. Data will be collected through an automated IVR. 1 month
Secondary Depression symptom severity Depression symptom severity will be assessed using the 9-item Patient Health Questionnaire (PHQ-9) a widely-used measure with excellent internal consistency and stability. Data will be collected through an automated IVR. 3 months
Secondary Depression symptom severity Depression symptom severity will be assessed using the 9-item Patient Health Questionnaire (PHQ-9) a widely-used measure with excellent internal consistency and stability. Data will be collected through an automated IVR. 6 months
Secondary Depression symptom severity Depression symptom severity will be assessed using the 9-item Patient Health Questionnaire (PHQ-9) a widely-used measure with excellent internal consistency and stability. Data will be collected through an automated IVR. 12 months
Secondary Pain Catastrophizing Scale The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain 1 month
Secondary Pain Catastrophizing Scale The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain 3 months
Secondary Pain Catastrophizing Scale The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain 6 months
Secondary Pain Catastrophizing Scale The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain 12 months
Secondary Sleep Quality Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and will assess subjective sleep quality. Data will be collected through automated IVR calls. 1 month
Secondary Sleep Quality Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and will assess subjective sleep quality. Data will be collected through automated IVR calls. 3 months
Secondary Sleep Quality Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and will assess subjective sleep quality. Data will be collected through automated IVR calls. 6 months
Secondary Sleep Quality Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and will assess subjective sleep quality. Data will be collected through automated IVR calls. 12 months
Secondary Pain Efficacy Self-Efficacy will be assessed using the 2-Item Short Form of the Pain Self-Efficacy Questionnaire (PSEQ-2). Data will be collected through automated IVR calls. 1 month
Secondary Pain Efficacy Self-Efficacy will be assessed using the 2-Item Short Form of the Pain Self-Efficacy Questionnaire (PSEQ-2). Data will be collected through automated IVR calls. 3 months
Secondary Pain Efficacy Self-Efficacy will be assessed using the 2-Item Short Form of the Pain Self-Efficacy Questionnaire (PSEQ-2). Data will be collected through automated IVR calls. 6 months
Secondary Pain Efficacy Self-Efficacy will be assessed using the 2-Item Short Form of the Pain Self-Efficacy Questionnaire (PSEQ-2). Data will be collected through automated IVR calls. 12 months
Secondary Health-Related Quality of Life We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls. 1 month
Secondary Health-Related Quality of Life We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls. 3 months
Secondary Health-Related Quality of Life We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls. 6 months
Secondary Health-Related Quality of Life We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls. 12 months
Secondary Pain Outcomes Pain outcomes will be measured using the Patient Outcomes Questionnaire. This 5-item measure shows good internal consistency and significant associations with staff and patient ratings of patient improvement. The data will be collected through automated IVR calls. 1 month
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