Cognitive Behavioral Therapy for Back and Neck Pain

(GOALS Trial)

Recruiting at 1 trial location

Overseen By Yessenia A Hernandez, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Tumor, Major health problems, Psychological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

138 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Sara Gombatto, PT, Ph.D

Principal Investigator

San Diego State University

Katrina Monroe, PT, Ph.D

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: GOALS Intervention Experimental Treatment 1 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 Therapy Active Control 1 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.

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+