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Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Back and Neck Pain (GOALS Trial)

N/A

Recruiting

Led By Sara Gombatto, PT, Ph.D

Research Sponsored by San Diego State University

Eligibility Criteria Checklist

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

Must have

18-66 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention (1-week, 3-month, 6-month)

Awards & highlights

GOALS Trial Summary

This trial is testing whether a culturally-adapted cognitive behavioral therapy program can help reduce pain-related disability for Hispanics/Latinos with chronic neck or low back pain, compared to usual care.

Who is the study for?

This trial is for Hispanic individuals aged 18-66 with chronic neck or low back pain, referred to physical therapy by a doctor. They must attend at least one session and cannot have major medical issues affecting the spine, severe mobility problems, be in litigation for pain, starting new psychotherapy for pain during the study, pregnant/lactating, or living with another participant.Check my eligibility

What is being tested?

The GOALS program—a culturally adapted cognitive behavioral tele-rehabilitation—is being tested against usual care physical therapy. It includes two in-person sessions and six weekly phone calls over eight weeks. The main goal is to see if GOALS reduces pain-related disability more effectively than standard treatment.See study design

What are the potential side effects?

Since this trial involves non-drug interventions like cognitive behavioral therapy and physical exercises provided via tele-rehabilitation or usual care physical therapy, typical medication side effects are not expected. However, participants may experience discomfort from engaging in new activities.

GOALS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 66 years old.

GOALS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention (1-week, 3-month, 6-month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention (1-week, 3-month, 6-month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention (1-week, 3-month, 6-month) for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

30-s Sit-to-Stand

6-Meter Walk Test

Brief Pain Inventory (BPI) - Pain Intensity

+5 more

Other outcome measures

Adverse Event Checklist

Fear Avoidance Beliefs Questionnaire (FABQ)

Global Impression of Change (GIC)

+23 more

GOALS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GOALS InterventionExperimental Treatment1 Intervention

The experimental arm is an 8-week cognitive-behavioral based physical therapy (PT) intervention for chronic spine pain. The manualized intervention utilizes a hybrid tele-rehabilitation delivery model. GOALS comprises an initial in-person evaluation (60 min) by a research physical therapist, followed by 6 remote treatment sessions (30-45 min each) conducted by the same physical therapist once a week by telephone. A second in-person evaluation is conducted at the midpoint of the GOALS intervention to assess progress and advance the participant's home exercise program.

Group II: Usual Care Physical TherapyActive Control1 Intervention

The control arm is Usual Care physical therapy (PT) at a local Federally Qualified Health Center (FQHC), which offers PT services at 4 outpatient clinics across San Diego county. Participants in the Usual Care group attend an initial PT evaluation at a FQHC Physical Rehabilitation Clinic. The frequency and type of PT intervention are then determined by the treating physical therapist in accordance with standard clinical practice at the FQHC.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

San Diego State UniversityLead Sponsor

153 Previous Clinical Trials

86,343 Total Patients Enrolled

Family Health Centers of San DiegoOTHER

6 Previous Clinical Trials

14,435 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,073 Total Patients Enrolled

Media Library

GOALS Intervention (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05005416 — N/A

Neck Pain Research Study Groups: GOALS Intervention, Usual Care Physical Therapy

Neck Pain Clinical Trial 2023: GOALS Intervention Highlights & Side Effects. Trial Name: NCT05005416 — N/A

GOALS Intervention (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05005416 — N/A

Neck Pain Patient Testimony for trial: Trial Name: NCT05005416 — N/A

Frequently Asked Questions

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

Does this research encompass individuals aged 55 and over?

"The age range for possible participants in this trial ranges from 18 to 66 years old."

Answered by AI

How many participants are currently engaging with this research project?

"Affirmative. According to information accessible on clinicaltrials.gov, this medical trial is actively seeking volunteers and began recruiting on August 4th 2021 with an update posted on May 13th 2022. The study requires 138 patients from two different sites for completion."

Answered by AI

Am I an eligible candidate for this medical trial?

"The research team is in search of 138 individuals between 18 and 66 years-old with chronic low back pain, who were referred to physical therapy by a primary care physician. Additionally, the participants must be Hispanic as well as attend at least one session of physical therapy treatment."

Answered by AI

Are there any available patient slots for this experiment?

"As of current, clinicaltrials.gov confirms that this medical trial is actively seeking participants. It was first posted on August 4th 2021 and the information has been most recently updated on May 13th 2022."

Answered by AI