Feasibility of Using Holographic Memory Resolution® (HMR) in Patients/Clients With Pain

NCT ID: NCT05001399

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2022-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study Purpose: This study will explore the feasibility of administering Holographic Memory Resolution® (HMR) to adults who are experiencing chronic pain for 6 months or more.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chronic pain is a significant health care problem and is one of the most common reasons individuals seek medical care. It is estimated that approximately 20.4% (50 million) of U.S. adults suffer from chronic pain, and 8% of those adults consider the pain to have high-impact on their quality of life. Chronic pain is also linked to many physical and mental health conditions, and for the most part, effective and safe strategies are lacking. While opioids are an option in the management of chronic pain, opioid misuse and abuse is common, making this a less desirable strategy. As noted, mental health concerns often co-exist with chronic pain. Depression and mental health concerns are skyrocketing across the U.S. Nearly one in five U.S. adults live with a mental illness, and only 50% of people with mental illnesses receive treatment. For those who do receive treatment, symptom resolution can be incomplete, and some psychotropic medications induce unwanted side effects, leading to decreased adherence and withdrawal of care.

Due to the scarcity of effective interventions to manage both chronic pain and mental health disorders, mind body interventions (MBI) are sometimes employed in these individuals. MBI are defined as a variety of activities that exercise and encourage mental and/or physical fitness. Lists of MBIs include diverse activities such as yoga, meditation, hypnosis, dance, or music therapy. Past meta-analyses have noted that primary studies on effective MBI to manage conditions such as fibromyalgia and depression in chronic pain are lacking. More recent publications indicate this is no longer the case. MBI may demonstrate small to moderate effects sizes in some populations for at least a short amount of time.

Holographic Memory Resolution® (HMR) is a proposed MBI for this study. HMR was developed by Brent Baum in the early 1990's, and he and several others have been using the technique to treat individuals with a variety of complaints including depression, anxiety, pain, post-traumatic stress disorder and related conditions. HMR incorporates elements of energy psychology, Eastern philosophical tradition, hypnosis, guided imagery, and clean-language interviewing into a single approach with the aim of changing the emotional component of a negative memory to resolve psychological distress. Despite being used for several decades, HMR appears to have received little attention in scientific literature. Only one citation appears in the National Library of Medicine, and this author only describes the technique. Theoretical, qualitative and quantitative studies of HMR appear to be non-existent in peer-reviewed literature.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Headache, Migraine Stress Disorders, Post-Traumatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot and Feasibility Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Holographic Memory Resolution® (HMR) Intervention

Intervention will be comprised of 4 sessions lasting approximately 90 minutes at one of two sites, Billings Clinic in Billings, Montana or Healing Dimensions AAC in Tucson, Arizona. The 4 sessions will be completed in approximately 9 weeks.

Group Type EXPERIMENTAL

Holographic Memory Resolution® (HMR)

Intervention Type BEHAVIORAL

Clients will participate in Holographic Memory Resolution® (HMR) administered by a trained HMR practitioner. Clients will be introduced to relaxation techniques and safe scene identification. This exercise encourages the client to identify a place in which they feel safe and where nobody can be there without client's invitation. Clients will then describe the place and associated colors of the experience, how the colors move in their body, and how they move through their safe scene. The subsequent 2-3 sessions will continue to explore safe scene and color therapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Holographic Memory Resolution® (HMR)

Clients will participate in Holographic Memory Resolution® (HMR) administered by a trained HMR practitioner. Clients will be introduced to relaxation techniques and safe scene identification. This exercise encourages the client to identify a place in which they feel safe and where nobody can be there without client's invitation. Clients will then describe the place and associated colors of the experience, how the colors move in their body, and how they move through their safe scene. The subsequent 2-3 sessions will continue to explore safe scene and color therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient age 18 years or older
* Suffering from pain of 4 or greater intensity on a 0-10 scale with "0" being no pain and "10" being worst possible pain.
* Pain symptoms will have been present for at least 6 months. Patients with chronic migraine headaches will be eligible if headaches occur at least every two months.
* Associated symptoms could include anxiety, depression, or physical symptoms such as pain, migraines, or other symptoms that have interfered with quality of life or work/life balance.
* Interested clients will have primary care provider agreement to participate in the study.

Exclusion Criteria

* Diagnosis of psychosis or schizoaffective disorder, personality disorder, or suicidal ideation.
* Clients taking mood altering substances and those that have a propensity toward altering delta, theta, alpha, and beta wave ranges will be excluded. These substances include but are not limited to Cannabis/Marijuana/ hashish/THC, PCP, phencyclidine, or Angel dust, Barbiturates, Benzodiazepines, Opioids/heroin, Clozapine (+++delta/slow waves/- - alpha waves), Lithium, Stimulants/ (Illicit: Cocaine, Methamphetamine), and Hallucinogens/MDMA (ecstasy)/LSD.
* Clients who ingest alcohol must be 3 months abstinent/in recovery before session if alcohol dependent and 48 hours abstinent before session if not alcohol dependent/in recovery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Healing Dimensions, ACC

UNKNOWN

Sponsor Role collaborator

Billings Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mary Gaddy

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary Gaddy, MD

Role: PRINCIPAL_INVESTIGATOR

Billings Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Healing Dimensions ACC

Tucson, Arizona, United States

Site Status

Billings Clinic

Billings, Montana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.

Reference Type BACKGROUND
PMID: 30212442 (View on PubMed)

Voon P, Karamouzian M, Kerr T. Chronic pain and opioid misuse: a review of reviews. Subst Abuse Treat Prev Policy. 2017 Aug 15;12(1):36. doi: 10.1186/s13011-017-0120-7.

Reference Type BACKGROUND
PMID: 28810899 (View on PubMed)

Fava M, Judge R, Hoog SL, Nilsson ME, Koke SC. Fluoxetine versus sertraline and paroxetine in major depressive disorder: changes in weight with long-term treatment. J Clin Psychiatry. 2000 Nov;61(11):863-7. doi: 10.4088/jcp.v61n1109.

Reference Type BACKGROUND
PMID: 11105740 (View on PubMed)

Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.

Reference Type BACKGROUND
PMID: 16172203 (View on PubMed)

Theadom A, Cropley M, Smith HE, Feigin VL, McPherson K. Mind and body therapy for fibromyalgia. Cochrane Database Syst Rev. 2015 Apr 9;2015(4):CD001980. doi: 10.1002/14651858.CD001980.pub3.

Reference Type BACKGROUND
PMID: 25856658 (View on PubMed)

Sud A, Lai KSP, Cheng DK, Chung C, Pico-Espinosa OJ, Rice DB. Mind-Body Interventions for Depressive Symptoms in Chronic Pain: A Systematic Review of Meta-Analyses. Pain Physician. 2021 Jan;24(1):61-72.

Reference Type BACKGROUND
PMID: 33400428 (View on PubMed)

Gomez-de-Regil L, Estrella-Castillo DF. Psychotherapy for Physical Pain in Patients with Fibromyalgia: A Systematic Review. Pain Res Manag. 2020 Jul 4;2020:3408052. doi: 10.1155/2020/3408052. eCollection 2020.

Reference Type BACKGROUND
PMID: 32714478 (View on PubMed)

Kwon CY, Lee B, Chung SY, Kim JW. Do Cochrane reviews reflect the latest evidence on meditation and mindfulness-based interventions? A snapshot of the current evidence. Explore (NY). 2021 Nov-Dec;17(6):557-565. doi: 10.1016/j.explore.2020.05.016. Epub 2020 May 30.

Reference Type BACKGROUND
PMID: 32527685 (View on PubMed)

Brandman W. Integrative perspectives. Holographic memory resolution. Perspect Psychiatr Care. 2005 Jul-Sep;41(3):139-41. doi: 10.1111/j.1744-6163.2005.00026.x. No abstract available.

Reference Type BACKGROUND
PMID: 16138824 (View on PubMed)

Murphy A, Steele M, Dube SR, Bate J, Bonuck K, Meissner P, Goldman H, Steele H. Adverse Childhood Experiences (ACEs) questionnaire and Adult Attachment Interview (AAI): implications for parent child relationships. Child Abuse Negl. 2014 Feb;38(2):224-33. doi: 10.1016/j.chiabu.2013.09.004. Epub 2013 Oct 24.

Reference Type BACKGROUND
PMID: 24670331 (View on PubMed)

Gierk B, Kohlmann S, Kroenke K, Spangenberg L, Zenger M, Brahler E, Lowe B. The somatic symptom scale-8 (SSS-8): a brief measure of somatic symptom burden. JAMA Intern Med. 2014 Mar;174(3):399-407. doi: 10.1001/jamainternmed.2013.12179.

Reference Type BACKGROUND
PMID: 24276929 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.

Reference Type BACKGROUND
PMID: 18752852 (View on PubMed)

Chen B, Van Assche J, Vansteenkiste M, Soenens B, Beyers W. Does Psychological Need Satisfaction Matter When Environmental or Financial Safety are at Risk? Journal of Happiness Studies. 2015;16(3):745-766.

Reference Type BACKGROUND

Chen B, Vansteenkiste M, Beyers W, et al. Basic psychological need satisfaction, need frustration, and need strength across four cultures. Motivation and Emotion. 2015;39(2):216-236.

Reference Type BACKGROUND

Nix G, Ryan R, Manly JB, Deci E. Revitalization through Self-Regulation: The Effects of Autonomous and Controlled Motivation on Happiness and Vitality. Journal of Experimental Social Psychology. 1999;35:266-284.

Reference Type BACKGROUND

Bostic TJ, Rubio DM, Hood M. A validation of the subjective vitality scale using structural equation modeling. Social Indicators Research. 2000;52(3):313-324.

Reference Type BACKGROUND

Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.

Reference Type BACKGROUND
PMID: 26653052 (View on PubMed)

Welsh JW, Durham RM, Sitar SI, Modisette KC, Estrada BD, Dennis ML. Diagnosing Adolescent Substance Use and Co-Occurring Disorders Using the Global Appraisal of Individual Needs Quick Version-4. Psychiatr Res Clin Pract. 2024 Jun 28;6(4):143-150. doi: 10.1176/appi.prcp.20230078. eCollection 2024 Winter.

Reference Type DERIVED
PMID: 39669537 (View on PubMed)

Gaddy MD, Baum B, Kiesow B, Coombs NC, Beamon ER, Mullowney Y, Williams GC, Brant JM. The Use of Holographic Memory Resolution(R) to Improve the Physical and Biopsychosocial Symptoms of Chronic Pain: A Feasibility, Mixed Methods Study. Psychiatr Res Clin Pract. 2023 Sep 19;6(1):4-11. doi: 10.1176/appi.prcp.20230028. eCollection 2024 Spring.

Reference Type DERIVED
PMID: 38510483 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.nimh.nih.gov/health/topics/index.shtml

National Institute of Mental Health. Mental Health Information. 2020.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21.012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HIRREM Developmental Study
NCT02709369 COMPLETED NA
Glymphatic MRI Study
NCT06452459 NOT_YET_RECRUITING