Social Intervention + Online CBT for Pain

(PANDA Trial)

Overseen By Christine O'Neill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Active cancer, Cognitive impairment, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

30 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for pain?

Research shows that cognitive behavioral therapy for chronic pain (CBT-CP), including online versions, is effective in helping people manage their pain. Studies highlight that making CBT-CP more accessible, especially through online platforms, can help people in rural or underserved areas who might not otherwise have access to this treatment. ^{1 2 3 4 5}

Is the combination of social intervention and online CBT for pain safe for humans?

Research on web-based cognitive behavioral therapy (CBT) for chronic pain shows it is generally safe, with minor and temporary adverse effects reported. The studies suggest that these interventions have a lower risk of adverse effects compared to medication-based treatments. ^{1 2 6 7 8}

How is the treatment 'Web-Based Cognitive Behavioral Therapy (PainTrainer)' unique for chronic pain?

This treatment is unique because it offers cognitive behavioral therapy (CBT) for chronic pain through an online platform, making it more accessible to people who may not have easy access to in-person therapy, especially in rural or underserved areas. It allows patients to manage their pain from home, which can be more convenient and cost-effective compared to traditional face-to-face therapy. ^{1 2 3 9 10}

What is the purpose of this trial?

The purpose of this study is to see if patients with chronic pain can improve how they manage their pain and daily function by working with a care manager and by learning pain coping skills from an online teaching tool.

Research Team

Dennis Ang, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Eligibility Criteria

This trial is for individuals who have been experiencing daily pain for at least three months, with a significant impact on their enjoyment and general activity. They must be under the care of an Atrium provider and face social challenges like financial insecurity or food scarcity. It's not open to those without these specific criteria.

Inclusion Criteria

I face challenges like financial issues, housing, or lack of social support.

I have been experiencing pain daily for at least 3 months.

My primary care doctor is with Atrium Health.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

Participants receive either PainTrainer or social intervention at study entry

12 weeks

At least 6 phone call visits for social intervention

Crossover Intervention

Participants switch to the alternate intervention (PainTrainer or social intervention) after 12 weeks

12 weeks

At least 6 phone call visits for social intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Social Intervention
• Web-Based Cognitive Behavioral Therapy (PainTrainer)

Trial Overview The study tests whether chronic pain management can improve by using a patient navigator—a type of care manager—and an online tool called PainTrainer that teaches coping skills.

Participant Groups

Group I: Social Intervention Followed by PainTrainer Experimental Treatment 2 Interventions

Participants will have social intervention at study entry. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care. At week 12, web-based cognitive behavior therapy (PainTrainer) will begin. PainTrainer is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Group II: PainTrainer Only Experimental Treatment 1 Intervention

At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Group III: PainTrainer Followed by Social Intervention Experimental Treatment 2 Interventions

At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. At Week 12, social intervention will begin. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

Web-Based Cognitive Behavioral Therapy (PainTrainer) is already approved in United States, European Union for the following indications:

Approved in United States as CBT-CP for:

• Chronic pain
• Chronic musculoskeletal pain
• Chronic low back pain

Approved in European Union as CBT-CP for:

• Chronic pain
• Chronic musculoskeletal pain

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

This trial involves 764 veterans with chronic musculoskeletal pain and compares an innovative remote cognitive behavioral therapy (CBT-CP) delivered via interactive voice response (IVR) to traditional in-person CBT-CP, aiming to determine which method is more effective in reducing pain interference after 4 months.

The study will assess not only pain interference but also other important factors like pain intensity, depression, and sleep, providing comprehensive insights into the effectiveness and implementation of these therapies in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-Operative Pain Education and Self-management (COPES) Expanding Treatment for Real-World Access (ExTRA): Pragmatic Trial Protocol. Heapy, AA., Driscoll, MA., Buta, E., et al.[2022]

The RESOLVE trial is a large-scale, 3-arm randomized control trial designed to compare the effectiveness of telephonic/video and online CBT for chronic pain against usual care, involving diverse populations across urban and rural areas.

This study aims to assess not only the clinical effectiveness of these CBT interventions in reducing pain severity but also their cost-effectiveness, potentially improving access to treatment for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Mayhew, M., Balderson, BH., Cook, AJ., et al.[2023]

A 1.5-day training program for therapists on online cognitive-behavioral therapy (iCBT) for chronic pain was developed, focusing on knowledge, skills, motivation, and organization, which are crucial for effective implementation.

Initial evaluations from 22 participating therapists indicated positive attitudes towards e-health and high acceptance of iCBT, suggesting that the training could enhance the integration of iCBT into clinical practice, although organizational support remains essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Becoming an eCoach: Training therapists in online cognitive-behavioral therapy for chronic pain. Terpstra, JA., van der Vaart, R., Spillekom-van Koulil, S., et al.[2019]

In a study of 108 individuals with chronic back pain undergoing cognitive behavioral therapy (CBT-CP), 46% experienced a significant reduction in pain intensity, while 66% increased their daily steps, indicating the therapy's effectiveness.

Most participants who responded positively to treatment achieved meaningful changes within 4 weeks for pain reduction and 2 weeks for increased activity, highlighting the potential for early benefits from CBT-CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial. MacLean, RR., Buta, E., Higgins, DM., et al.[2023]

Chronic pain treatments utilizing new information and communication technologies, such as online therapies and patient discussion forums, have been found to be generally effective and efficient based on a review of eight studies.

Patients reported positive attitudes towards these technology-based treatments, although the effectiveness varied due to differences in study design, indicating a need for standardized approaches in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New information and communication technologies in the treatment of chronic pain]. Nieto, R., Miró, J., Huguet, A.[2019]

Internet-based cognitive behavioral therapy (CBT) interventions for chronic pain have shown significant efficacy, with improvements in disability/interference (Hedge's g = -0.39) and pain intensity (Hedge's g = -0.33) across 22 trials involving various chronic pain diagnoses.

The interventions also positively impacted psychological factors such as catastrophizing (Hedge's g = -0.49) and depression (Hedge's g = -0.26), indicating that these online treatments can effectively address both physical and mental health aspects of chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet interventions for chronic pain including headache: A systematic review. Buhrman, M., Gordh, T., Andersson, G.[2022]

Web-based cognitive behavioral interventions for chronic pain showed a small but statistically significant effect, with a pooled effect size of 0.285, indicating some benefit over waiting-list controls based on 11 studies.

Despite a high dropout rate of 26.6%, the low cost and minimal risk of adverse effects compared to traditional pharmacological treatments suggest that web-based interventions could be a valuable option for managing chronic pain, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. Macea, DD., Gajos, K., Daglia Calil, YA., et al.[2022]

A 10-week walking program integrated into cognitive behavioral therapy for chronic pain significantly increased participants' daily step counts by an average of 1648 steps, indicating its effectiveness in promoting physical activity.

The program was safe, with mostly minor and temporary adverse events reported, and it was equally effective whether delivered in person or via interactive voice response, suggesting flexibility in treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention. Heapy, AA., Tankha, H., Higgins, DM., et al.[2023]

A pilot study involving 47 chronic pain patients showed that group cognitive behavioral therapy (CBT) delivered via teletherapy is feasible and well-tolerated, with 62.5% of participants rating it as very helpful.

Both online and in-person CBT groups demonstrated similar modest improvements in coping with chronic pain, suggesting that online therapy could be an effective alternative to traditional in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online group pain management for chronic pain: Preliminary results of a novel treatment approach to teletherapy. Mariano, TY., Wan, L., Edwards, RR., et al.[2021]

Guided internet-based cognitive-behavioral therapy (iCBT) has been shown to be effective for chronic pain management, outperforming both passive and active control conditions in improving psychological, physical, and daily life outcomes across 33 studies with 5133 participants.

The treatment was generally safe with high satisfaction rates and minor adverse events, although dropout rates were influenced by factors like time commitment and technical issues, suggesting that optimizing delivery methods could enhance patient retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. Terpstra, JA., van der Vaart, R., van Beugen, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Co-Operative Pain Education and Self-management (COPES) Expanding Treatment for Real-World Access (ExTRA): Pragmatic Trial Protocol. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Becoming an eCoach: Training therapists in online cognitive-behavioral therapy for chronic pain. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

[New information and communication technologies in the treatment of chronic pain]. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Internet interventions for chronic pain including headache: A systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Online group pain management for chronic pain: Preliminary results of a novel treatment approach to teletherapy. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. [2022]