NCT06820242

Open Pilot Trial of a Mind-Body Intervention for Patients With Chronic Hip Pain

Development and Feasibility of a Mind-Body Intervention to Improve Physical Activity for Patients With Chronic Hip Pain: Open Pilot (HIPS Study)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic hip joint-related pain (HRP). We will use this mixed methods information to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT). Deliverables: \[1\] Adapt and refine open pilot protocol, patient recruitment, provider training, and other study materials. \[2\] Assess the feasibility, acceptability, and credibility of HIPS in preparation for a future feasibility RCT.

Detailed description

Aim: Conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic HRP. The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT). HIPS Intervention: HIPS is a 6-session (one 30-minute session per week) mind-body intervention delivered virtually via live-video by a trained physical therapist (PT). In addition to participating in the HIPS intervention, all participants will attend their prescribed physical therapy with a physical therapist of their choosing. To minimize variability in physical rehabilitation, we will send the physical therapist the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. Across the six 30-minute sessions, the HIPS intervention aims to teach relaxation and coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and provides pain education. After each session, the participant is instructed to set and meet a physical activity SMART goal for the coming week. Within the program manual will be a log where the participant may track their completion of home practice. Each week, participants will receive a survey to formally report their daily home practice data over the last 7 days. Following program completion, there will be a one-time 30-minute virtual exit interview to elicit subject perceptions of HIPS and any recommendations to improve intervention quality. This information will be used to further adapt and optimize HIPS prior to future efficacy testing. Assessments: Baseline (0 weeks), post-test (6 weeks), and 6-month follow-up (30 weeks) survey assessments.

Conditions

• Hip Pain
• Hip Pain Chronic
• Mind-Body Therapies

Interventions

Type	Name	Description
BEHAVIORAL	HIPS	HIPS is a 6-session (one 30-minute session per week) mind-body intervention delivered virtually via live video by a trained physical therapist (PT). Across these six 30-minute sessions, the HIPS intervention aims to teach relaxation and coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and provides pain education.

Timeline

• Start date: 2025-04-04
• Primary completion: 2026-04-30
• Completion: 2026-09-01
• First posted: 2025-02-11
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States