Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings (TOPPS)
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|ClinicalTrials.gov Identifier: NCT03698669|
Recruitment Status : Not yet recruiting
First Posted : October 8, 2018
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders||Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS) Behavioral: Health Education (HE)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2023|
Experimental: Treating Opioid Patients' Pain and Sadness (TOPPS)
TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.
Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)
TOPPS involves an initial face-to-face meeting followed by regular phone meetings. In preliminary research, patients found this format to be convenient. The initial meeting includes the patient, the BHS and the PCP; the PCP then regularly receives treatment notes from the BHS. Also, the PCP, who has a longitudinal relationship with the patient, is encouraged to further reinforce TOPPS goals. After each TOPPS session, the BHS also mails a copy of the clinical note to the patient. Additionally, each participant is provided with a workbook that reviews the key elements of each treatment session and provides exercises for at-home practice of skills.
Active Comparator: Health Education (HE)
After an initial, brief, joint, in-person meeting with the BHS and primary care physician (PCP), patients have a session that discusses nutrition. For the next 5 telephone sessions, they choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.
Behavioral: Health Education (HE)
After an initial, brief, joint, in-person meeting with the BHS and primary care physician (PCP), patients have a session that discusses nutrition. For the next 5 telephone sessions, they choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity. This control condition was accepted by our participants in preliminary studies; it does not directly target functional impairment, and participants do not set tailored goals relating to their own values. The BHS will communicate with the PCP only if a participant shows signs of clinical deterioration.
- Change in Pain Interference based on the BPI-I [ Time Frame: Baseline and Month 12 ]The Brief Pain Inventory Interference Scale (BPI-I) will be used to capture the domain of pain interference with physical and psychosocial functioning. The pain interference subscale includes 7 questions assessing the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life using a 0-to-10 numeric rating score. For interference items, 0 represents "does not interfere" and 10 indicates "interferes completely."
- Change in Pain Severity based on the VAS [ Time Frame: Baseline and Month 12 ]Pain severity will be measured by the Visual Analogue Scale (VAS) presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Participants will indicate "worst" and "average" pain in the last week.
- Change in Depression based on the QIDS [ Time Frame: Baseline and Month 12 ]The Quick Inventory of Depression Symptoms (QIDS) will be used to measure depression severity and suicidality. It is a commonly-used clinical interview that yields a depression severity score between 0 and 27 with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
- Rates of buprenorphine treatment retention [ Time Frame: Month 12. ]Using clinical records at the recruitment sites, we will record the date of last buprenorphine treatment visit and calculate the treatment retention rates up to 12 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698669
|Contact: Michael D Stein, MDfirstname.lastname@example.org|
|Contact: Julia E Keosaian, MPHemail@example.com|
|United States, Massachusetts|
|Boston Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Alicia Ventura|
|Principal Investigator:||Michael D Stein, MD||Boston University|