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Behavioral Intervention

Physical Self-Regulation, PSR for Muscle Pain (BBTI_PSR_21 Trial)

N/A

Waitlist Available

Research Sponsored by Linda Sangalli

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)

Awards & highlights

BBTI_PSR_21 Trial Summary

This trial will compare two methods of psychological intervention delivered over telehealth to help manage chronic pain conditions.

Eligible Conditions

Muscle Pain
Myofascial Pain Syndrome

BBTI_PSR_21 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Self-report Average Pain Intensity

Sleeplessness

Change in Self-report Quality of Life

Secondary outcome measures

Change in Self-report Anxiety Symptoms

Change in Self-report Depression Symptoms

Change in Self-report Headache Frequency

+3 more

BBTI_PSR_21 Trial Design

2Treatment groups

Experimental Treatment

Group I: Physical Self-Regulation, PSRExperimental Treatment1 Intervention

Participants in this group will receive 3 sessions of PSR over telehealth.

Group II: Brief Behavioral Therapy for Insomnia, BBTIExperimental Treatment1 Intervention

Participants in this group will receive 3 sessions of BBTI over telehealth.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brief Behavioral Therapy for Insomnia, BBTI

2021

N/A

~20

Physical Self-Regulation, PSR

2021

N/A

~20

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Linda SangalliLead Sponsor

Ian Boggero, PhDLead Sponsor

1 Previous Clinical Trials

104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the hoped-for results from this investigation?

"The primary aim of this study, to be assessed before and after the intervention is administered, pertains to changes in self-reported insomnia symptoms. Other objectives include looking into modifications in anxiety symptoms (via PHQ4) as well as sleep quality (with RU-SATED) and headache frequency (utilizing MIDAS). Scores on these questionnaires can range from 0 - 4 or 0 - 150 respectively; with a cut off score of 3 indicative of possible depression requiring referral for counselling. Morning and evening diaries will also be employed daily via REDCap surveys."

Answered by AI

How many individuals are participating in this research endeavor?

"Affirmative, the clinical trial is presently recruiting patients. According to details posted on clinicaltrials.gov, enrolment for this study opened October 21st 2021 and was last updated November 16th 2022. The research team seeks 100 volunteers across a single site."

Answered by AI

Are there presently any opportunities to join this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this scientific trial is currently in the process of recruiting patients, which began on October 21st 2021 and was recently updated November 16th 2022. The research requires 100 participants from a single site to partake."

Answered by AI