Psychological Interventions for Pain Perception

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Lauren Y Atlas, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Must not be taking: Opiates, Antidepressants, Anticonvulsants, others

Disqualifiers: Cardiovascular, Neurological, Mood disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: - Painful stimuli cause changes in a network of brain regions called the "Pain Matrix." But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision. Objectives: - To better understand how pain and emotions are processed and influenced by psychological factors. Eligibility: - Healthy volunteers ages 18-50. Design: * This study requires 1 to 2 clinic visits that last 1 to 3 hours. * Participants will be screened with medical history and physical exam. * Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs. * Participants heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored. * Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI. * Participants will fill out questionnaires. * The study will last 3 years.

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

Yes, if you regularly use prescription medications that significantly affect pain or heat perception, you will need to stop taking them to participate in the trial. This includes medications like opiates, antidepressants, anticonvulsants, and others listed in the exclusion criteria.

What data supports the effectiveness of the treatment Attention, Mindfulness, Cognitive Training, Focus Therapy, Instructions, Liquid tastants, Placebo instructions, Thermal Pain for pain perception?

Research suggests that psychological interventions like mindfulness and cognitive strategies can help manage pain by changing how people think about and experience it. Mindfulness, in particular, has been shown to improve pain outcomes by increasing pain tolerance and reducing pain intensity, partly due to the belief in its effectiveness. ^{1 2 3 4 5}

Is it safe to participate in psychological interventions for pain perception?

Research on psychological interventions like mindfulness and attention training for pain perception suggests they are generally safe for humans. These studies often involve healthy participants and focus on cognitive processes without reporting significant adverse effects. ^{1 4 6 7 8}

How is the treatment in the trial 'Psychological Interventions for Pain Perception' different from other treatments for pain?

This treatment is unique because it focuses on psychological strategies like distraction and attention redirection to manage pain, rather than relying on medication. These strategies involve shifting focus away from pain, which can help reduce the perception of pain intensity. ^{9 10 11 12 13}

Research Team

Lauren Y Atlas, Ph.D.

Principal Investigator

National Center for Complementary and Integrative Health (NCCIH)

Eligibility Criteria

This trial is for healthy individuals between the ages of 18 and 50 who speak English fluently and can consent to participate. It's not suitable for those with conditions affecting touch sensation, chronic pain history, skin issues in test areas, major medical conditions that affect heat sensitivity or pain thresholds, pregnancy, NCCIH/NIMH employees, or regular use of certain prescription medications.

Inclusion Criteria

You are in good overall health.

I am between 18 and 50 years old.

Fluent in English

Exclusion Criteria

I have or had a pain condition lasting more than six months.

I have a health condition that could affect my sensitivity to heat, pain, or ability to follow study rules.

I have scars, burns, or a recent tattoo that could affect skin sensitivity in the test area.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Study Visits

Participants undergo various tests including MRI scans, taste tests, and pain assessments. Physiological responses are measured.

1-3 hours per visit

1 to 2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after study visits

4 weeks

Treatment Details

Interventions

• Attention (Behavioural Intervention)
• Instructions (Behavioural Intervention)
• Liquid tastants (Behavioural Intervention)
• Placebo instructions (Behavioural Intervention)
• Thermal Pain (Behavioural Intervention)

Trial Overview The study aims to understand how psychological factors like expectations influence pain perception and decision-making. Participants may undergo MRI scans while experiencing controlled thermal pain or electric shocks, perform tasks, take taste tests, and complete questionnaires during one to two clinic visits over three years.

Participant Groups

Group I: Substudy 5: healthy volunteers Experimental Treatment 2 Interventions

Participants experience both placebo and cue-based expectations within subjects

Group II: Substudy 4: healthy volunteers Experimental Treatment 1 Intervention

Participants are instructed to attend toward or away from the stimulus

Group III: Substudy 2: sugar group Experimental Treatment 1 Intervention

Participants learn about sugar outcomes through conditioning

Group IV: Substudy 2: salt group Experimental Treatment 1 Intervention

Participants learn about salt outcomes through conditioning

Group V: Substudy 2: heat group Experimental Treatment 1 Intervention

Participants learn about heat outcomes through conditioning

Group VI: Substudy 1: Uninstructed subjects Experimental Treatment 1 Intervention

Participants learn through experience

Group VII: Substudy 1: Instructed subjects Experimental Treatment 1 Intervention

Participants are instructed about outcomes

Group VIII: Substudy 3: healthy volunteers Active Control 1 Intervention

All participants experience all outcomes, within subjects designs

Who Is Running the Clinical Trial?

National Center for Complementary and Integrative Health (NCCIH)

Lead Sponsor

Trials

886

Recruited

677,000+

Dr. Amy P. Patterson

National Center for Complementary and Integrative Health (NCCIH)

Chief Medical Officer

MD from Johns Hopkins University

Dr. Helene Langevin

National Center for Complementary and Integrative Health (NCCIH)

Chief Executive Officer since 2018

MD from McGill University

Findings from Research

In a study of 153 healthy adults, both mindfulness and sham interventions led to improved pain outcomes compared to no treatment, indicating that any form of intervention can help reduce pain.

The belief in receiving mindfulness treatment significantly predicted increased pain tolerance, suggesting that expectancy and belief may be more influential in pain relief than the specific mindfulness techniques used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do placebo effects contribute to mindfulness-based analgesia? Probing acute pain effects and interactions using a randomized balanced placebo design. Davies, JN., Sharpe, L., Day, MA., et al.[2022]

Psychological interventions, such as mindfulness and cognitive coaching, can significantly influence analgesic requirements and improve patient outcomes in managing chronic or acute wound pain, suggesting a complementary role alongside traditional pain medications.

Recent systematic reviews indicate that these interventions may enhance patient experiences and clinical outcomes during and after surgical procedures, highlighting their potential effectiveness in pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Methods of Managing Surgical Pain. Bolton, L.[2021]

Chronic pain patients who underwent cognitive treatment showed effective changes in their pain experience, indicating that cognitive strategies can help manage clinical pain.

The study suggests that pain can be viewed as a cognitive label for a general state of arousal, highlighting the importance of mental processes in pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reinterpretative cognitive strategies in chronic pain management. Blinchik, ER., Grzesiak, RC.[2011]

Open monitoring (OM) meditation techniques show promise in reducing both sensory and emotional aspects of pain, while focused attention (FA) practices are generally less effective for pain relief.

The neural mechanisms involved in OM suggest that practitioners can focus on pain while suppressing other thoughts, aligning with mindfulness principles, and there is potential for further exploration of compassion meditation as a pain management technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditative analgesia: the current state of the field. Grant, JA.[2022]

A pilot study involving 147 persistent pain patients tested a brief mindfulness-based intervention (MBI) and found it feasible to recruit participants, although there were no significant immediate effects on pain severity.

The MBI group reported greater 'usefulness' of the intervention at 1 week and improved pain self-efficacy at 1 month compared to the control group, suggesting potential long-term benefits of mindfulness practices for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of a brief mindfulness-based intervention for those with persistent pain. Howarth, A., Riaz, M., Perkins-Porras, L., et al.[2021]

Long-term meditation practitioners experienced a significant reduction in the unpleasantness of pain during Open Monitoring meditation, suggesting that this technique enhances emotional regulation in response to pain.

Focused Attention meditation did not show any significant effects on pain perception, indicating that Open Monitoring may be a more effective approach for managing negative emotional responses to painful stimuli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects on pain intensity and unpleasantness of two meditation practices. Perlman, DM., Salomons, TV., Davidson, RJ., et al.[2022]

The study involved 103 undergraduate students and found that an attention training technique (ATT) reduced hypervigilance to pain-related words, suggesting it can alter cognitive processes related to pain perception.

Participants who received ATT reported pain less quickly than those who underwent progressive muscle relaxation, indicating that ATT may help in managing the initial response to pain, although it did not significantly change overall pain ratings or tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effect of attention training and relaxation on responses to pain. Sharpe, L., Perry, NK., Rogers, P., et al.[2022]

Retraining attentional bias towards neutral stimuli using a short stimulus duration (500 ms) significantly increased pain threshold and tolerance in pain-free volunteers compared to a placebo group.

In contrast, a longer stimulus duration (1250 ms) did not produce any beneficial effects on pain outcomes, indicating that shorter exposure times may be more effective for modifying pain responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attentional bias modification for acute experimental pain: A randomized controlled trial of retraining early versus later attention on pain severity, threshold and tolerance. Bowler, JO., Bartholomew, KJ., Kellar, I., et al.[2018]

Distraction techniques, which involve focusing on activities or thoughts other than pain, are effective strategies for pain management, as they help compete for attention against the sensation of pain.

While distraction is generally endorsed for acute pain relief, its effectiveness in chronic pain situations is less clear, suggesting that caution should be exercised when applying these techniques in long-term pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does distraction work in the management of pain? Johnson, MH.[2022]

Relaxation training effectively reduced distress and verbally reported pain in individuals experiencing acute ischemic pain, while simple relaxation instructions did not show any significant benefits.

The attention-redirection technique was also effective in reducing pain as measured by cross-modality matching, suggesting that focusing attention away from pain can be a useful strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relaxation training and cognitive redirection strategies in the treatment of acute pain. Clum, GA., Luscomb, RL., Scott, L.[2021]

A mental strategy that involves shifting attention from painful stimuli to self-generated, less painful images can help modulate the perception of pain intensity, as shown in a study with 18 pain-free participants.

The study found that this focus-and-orient strategy activates specific brain waves (P2, P3, N400, and P600) that correlate with reduced pain ratings, suggesting that maintaining sub-nociceptive images in working memory can effectively alter pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orienting attention modulates pain perception: an ERP study. Chan, SC., Chan, CC., Kwan, AS., et al.[2022]

Chronic pain patients with high intensity pain showed significantly impaired performance on attention-demanding tasks compared to those with low pain and normal controls, indicating that high pain levels can negatively affect cognitive function.

The study suggests that low intensity pain patients may cope better by quickly switching their attention between pain and tasks, highlighting the potential for attention-based coping strategies to help manage pain in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic pain and distraction: an experimental investigation into the role of sustained and shifting attention in the processing of chronic persistent pain. Eccleston, C.[2019]

Cognitive behavioural therapy (CBT) is the most effective psychological intervention for managing chronic pain, showing significant benefits in pain, mood, and disability for adults and adolescents.

Despite its effectiveness, the overall impact of psychological treatments for chronic pain is modest, indicating that while CBT can help, it may not be a complete solution on its own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological approaches to chronic pain management: evidence and challenges. Eccleston, C., Morley, SJ., Williams, AC.[2022]

References

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

How do placebo effects contribute to mindfulness-based analgesia? Probing acute pain effects and interactions using a randomized balanced placebo design. [2022]

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

Psychological Methods of Managing Surgical Pain. [2021]

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

Reinterpretative cognitive strategies in chronic pain management. [2011]

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

Meditative analgesia: the current state of the field. [2022]

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

Pilot randomised controlled trial of a brief mindfulness-based intervention for those with persistent pain. [2021]

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

Differential effects on pain intensity and unpleasantness of two meditation practices. [2022]

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

A comparison of the effect of attention training and relaxation on responses to pain. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Attentional bias modification for acute experimental pain: A randomized controlled trial of retraining early versus later attention on pain severity, threshold and tolerance. [2018]

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

How does distraction work in the management of pain? [2022]

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

Relaxation training and cognitive redirection strategies in the treatment of acute pain. [2021]

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

Orienting attention modulates pain perception: an ERP study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Chronic pain and distraction: an experimental investigation into the role of sustained and shifting attention in the processing of chronic persistent pain. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Psychological approaches to chronic pain management: evidence and challenges. [2022]