138 Participants Needed

Cognitive Behavioral Therapy for Back and Neck Pain

(GOALS Trial)

Recruiting at 1 trial location
CR
YA
Overseen ByYessenia A Hernandez, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: San Diego State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests the GOALS program, which combines various sessions to help Hispanic/Latino people with long-term neck or back pain. The program uses mental and physical exercises to manage pain. It aims to improve daily functioning by changing how patients think about and respond to their pain.

Research Team

SG

Sara Gombatto, PT, Ph.D

Principal Investigator

San Diego State University

KM

Katrina Monroe, PT, Ph.D

Principal Investigator

San Diego State University

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with chronic neck or low back pain.
I will attend at least one physical therapy session.
This criterion means that individuals of Hispanic descent are being considered for the study.
See 1 more

Exclusion Criteria

I have a major issue with my neck or low back, such as a tumor or infection.
I have severe health issues that limit my mobility and exercise ability.
I am starting or currently in therapy for neck or low back pain.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants provide written informed consent and undergo baseline assessment

1 week
1 visit (in-person)

Treatment

Participants receive either the GOALS intervention or Usual Care PT for 8 weeks

8 weeks
2 visits (in-person), 6 visits (telephone for GOALS group)

Post-Intervention Assessment

Assessment conducted 1 week after completing the 8-week treatment

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
2 visits (in-person) at 3-month and 6-month post-intervention

Treatment Details

Interventions

  • GOALS Intervention
  • Usual Care Physical Therapy
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials
182
Recruited
119,000+

Family Health Centers of San Diego

Collaborator

Trials
9
Recruited
15,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+
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