Cognitive Behavioral Therapy for Back and Neck Pain

(GOALS Trial)

No longer recruiting at 1 trial location

Overseen By Yessenia Hernandez

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a culturally adapted cognitive behavioral therapy program for Hispanic/Latino individuals with chronic neck or low back pain. Participants will either join an 8-week tele-rehabilitation program called the GOALS Intervention or receive the usual care at a local clinic. Researchers aim to determine if this new approach can reduce pain-related disability more effectively than standard physical therapy. Hispanic individuals experiencing chronic neck or low back pain and referred to physical therapy may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research tailored to the community's needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cognitive behavioral therapy program is safe for treating back and neck pain?

Research has shown that cognitive behavioral therapy (CBT), such as the GOALS program, is generally safe for managing long-term pain. Studies have found that CBT can safely reduce pain and improve functionality. For example, a review of several studies found that CBT provided significant pain relief and outperformed standard care. Another study confirmed these results, showing safe improvements in pain management and overall function. No major negative effects have been reported with CBT, making it a well-tolerated choice for chronic spine pain. This therapy helps change thought patterns to manage pain without medication, reducing the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GOALS Intervention for back and neck pain because it combines cognitive-behavioral therapy with physical therapy in an innovative way. Unlike traditional in-person treatments, GOALS uses a hybrid tele-rehabilitation model, allowing patients to receive therapy remotely, which can be more convenient and accessible. This approach not only targets the physical aspects of pain but also addresses the mental components, potentially leading to more comprehensive and effective pain management.

What evidence suggests that this trial's treatments could be effective for chronic spine pain?

Research has shown that cognitive behavioral therapy (CBT) can aid individuals with chronic low back pain by improving pain, reducing disability, and boosting confidence in pain management. In this trial, participants may receive the GOALS Intervention, an experimental CBT-based program. Studies have found it often outperforms standard treatments in reducing pain and disability. Although evidence for neck pain is less robust, CBT still positively affects chronic back pain. The GOALS program has been specially adapted for Hispanic and Latino individuals, potentially enhancing its effectiveness for them. Overall, CBT is well-supported as a helpful treatment for chronic spine pain. ^{3 4 5 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05005416

Goal Oriented Activity for Latinos With Spine Pain The primary aim of the study is to determine the efficacy of a culturally adapted cognitive behavioral based PT tele-rehabilitation program compared to usual ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8957446/

Evaluation of Cognitive Behavioral Therapy on Improving ... CBT is beneficial in patients with CLBP for improving pain, disability, fear avoidance, and self-efficacy in CLBP patients.

3. icer.org icer.org/wp-content/uploads/2020/10/CTAF_Chronic_Pain__Evidence_Report_100417.pdf

Cognitive and Mind-Body Therapies for Chronic Low Back ... Cognitive Behavioral Therapy. The evidence for the effectiveness of CBT for the treatment of chronic neck pain is less robust than the evidence for low back ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0325122

The effect of cognitive behavioural therapy on pain and ... Results showed that CBT is more effective in reducing pain and disability compared to waiting list/usual care (WL/UC). CBT in conjunction with other active ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... Results of the study suggest that both treatments have potential utility in treating adults with refractory CLBP and improving pain, function, and quality-of- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637560/

Efficacy of cognitive behavioral therapy for reducing pain ... This study is a systematic evaluation of the literature related to the efficacy of CBT for chronic low back pain and is the first meta-analysis ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.