Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV (STOMP)
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|ClinicalTrials.gov Identifier: NCT03692611|
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : August 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Skills TO Manage Pain (STOMP) Behavioral: comparison group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomized controlled trial to discover whether STOMP is an efficacious Pain Self-Management (PSM) intervention, mediated by the hypothesized Social Cognitive Theory (SCT) constructs.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV|
|Actual Study Start Date :||August 14, 2019|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Experimental: Skills to Manage Pain (STOMP)
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Behavioral: Skills TO Manage Pain (STOMP)
12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
Active Comparator: comparison group
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
Behavioral: comparison group
Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
Other Name: active comparator
- Brief Pain Inventory (BPI) score immediately post intervention [ Time Frame: BPI will be conducted at baseline and immediately after the intervention ]the BPI asks 11 questions about pain severity (pain at its worst, least, average, and right now) and the interference of pain in several aspects of patients' lives (activity, mood, walking ability, work, relations with other people, sleep, and enjoyment of life) on a scale of 0 (no pain/does not interfere) to 10 (pain as bad as you imagine/completely interferes). The BPI-Total score is the average score across all 11 questions.
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): NCT03692611
|Contact: Deena Blumenfeld, BAemail@example.com|
|Contact: Adam Buttafirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama||Recruiting|
|Birmingham, Alabama, United States, 352940|
|Contact: Greer Greer Burkholder, MD 205-934-1917 email@example.com|
|Principal Investigator: Greer Burkholder, MD|
|United States, North Carolina|
|University of North Carolina||Enrolling by invitation|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Jessica Merlin, MD PhD MBA||Univ of Pittsburgh|