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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a web-based program and support from a care manager can help people with chronic pain manage their pain and improve daily living. The study tests three approaches: using an online tool called PainTrainer, starting with a social support program (Social Intervention), or a combination of both. PainTrainer provides coping skills for pain through eight self-guided sessions. Ideal candidates for the trial are those who have experienced daily musculoskeletal pain for more than three months and face challenges such as financial insecurity or lack of social support. As an unphased trial, this study offers participants a unique opportunity to explore innovative pain management strategies that could enhance their quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that online cognitive behavioral therapy (CBT), such as PainTrainer, is generally safe for individuals with chronic pain. Studies have found that patients using online CBT experienced significant improvements in pain management and exhibited fewer negative behaviors related to pain medication. They also demonstrated less negative thinking about their pain.

Social support, including assistance from care managers or patient navigators, has been linked to positive outcomes. These support systems can reduce feelings of loneliness and enhance emotional well-being. No major safety concerns have been reported for these social support methods.

Overall, previous studies have found both treatments to be well-received. They aim to improve pain management without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for pain management because they combine traditional cognitive behavioral therapy (CBT) with innovative delivery methods and social support. Unlike standard pain treatments, which often rely on medication or in-person therapy sessions, these programs offer a self-guided, web-based CBT called PainTrainer. This approach allows participants to learn coping strategies at their own pace, which can be more convenient and accessible. Additionally, the integration of social intervention through personalized phone calls provides an extra layer of support, which can help improve adherence and effectiveness. These features make the treatments stand out as potentially more flexible and supportive alternatives for managing pain.

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

This trial will evaluate different approaches to managing chronic pain. Research has shown that online cognitive behavioral therapy (CBT), such as PainTrainer, can help reduce chronic pain. Studies have found that people using online CBT experience less pain-related behavior and develop more positive thoughts about their pain. One study found that this method can lower pain levels more effectively than waiting for other treatments.

In this trial, some participants will receive PainTrainer followed by a social intervention, while others will start with the social intervention before receiving PainTrainer. Research emphasizes the importance of social support in managing chronic pain. Training in social skills and having support can improve social interactions and reduce feelings of loneliness, which are linked to better pain management. Together, these approaches aim to provide tools and support to help people manage their pain more effectively. ^{1 4 6 7 8}

Who Is on the Research Team?

Dennis Ang, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8742845/

Beyond pain, distress, and disability: the importance of ... Social isolation and low perceived social support is associated with worsening pain, distress, and disability over time.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9120981/

Effectiveness of Social Skills Training Groups in Persons ... The study aimed to evaluate the effectiveness of a social skills training program provided at the occupational therapy unit of a tertiary care center in India.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/15291006211008157

Psychological Interventions for the Treatment of Chronic ... Psychological treatments designed to alter processes that underlie or significantly contribute to pain, distress, or disability among adults with chronic pain.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213398423001689

Effectiveness of social skill program for social performance ... Social skills training focuses on improvement of social interaction, performance, interpersonal skills, and to reduce social anxiety. 11The approach of social ...

5. researchonline.lshtm.ac.uk researchonline.lshtm.ac.uk/id/eprint/4670478/1/Saran-etal-2023-Effectiveness-of-interventions-for-improving.pdf

Effectiveness of interventions for improving social inclusion ... Social inclusion outcomes can be improved through interventions designed to develop skills for social inclusion (e.g., social and communication skill training), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9579460/

A Community Health Worker-Led Positive Psychology ... A community health worker-led chronic pain self-management intervention combining positive activities with self-management skills training demonstrated the ...

7. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074823001762

Internet-Delivered Dialectical Behavioral Therapy Skills ... The secondary outcomes include pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, posttraumatic stress, harm avoidance, ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/15/1/e095354

Investigating a caregiver-assisted social skills group ... This trial will explore the perspectives and experiences of school-aged children (grades 3+; 8–13 years) and caregivers who participate in the Programme for the ...