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

October 31, 2022 updated by: Mary Gaddy, Billings Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Healing Dimensions ACC
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion Rate of an HMR Intervention
Time Frame: Following 4 HMR sessions, approximately 8-9 weeks per participant.
The percentage of patients who complete 4 HMR sessions.
Following 4 HMR sessions, approximately 8-9 weeks per participant.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Somatic Symptomatic Scale (SSS-8)
Time Frame: Baseline, prior to Session 3 ( Day 14-24), prior to Session 4 (8-9 weeks), and 1 month after Session 4.
The SSS-8, an abbreviated version of the PHQ-15, is a validated 8-item client-report measure of somatic symptom burden. Respondents are asked to answer the question "During the past 7 days, how much have you been bothered by any of the following problems?" concerning gastrointestinal, pain, fatigue, and cardiopulmonary aspects. Items are scored on a 5-point Likert scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). Somatic symptom scoring ranges from 0-32 [(no to minimal (0-3 points), low (4-7 points), medium (8-11 points), high (12-15 points), and very high (16-32 points)].
Baseline, prior to Session 3 ( Day 14-24), prior to Session 4 (8-9 weeks), and 1 month after Session 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Billings Clinic

Collaborators

Healing Dimensions, ACC

Investigators

  • Principal Investigator: Mary Gaddy, MD, Billings Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Actual)

June 29, 2022

Study Completion (Actual)

July 18, 2022

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21.012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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