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

Primary Purpose

Chronic Pain, Headache, Migraine, Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Holographic Memory Resolution® (HMR)
Sponsored by
Billings Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Healing Dimensions ACC
  • Billings Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Holographic Memory Resolution® (HMR) Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Completion Rate of an HMR Intervention
The percentage of patients who complete 4 HMR sessions.

Secondary Outcome Measures

Somatic Symptomatic Scale (SSS-8)
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)].

Full Information

First Posted
July 29, 2021
Last Updated
October 31, 2022
Sponsor
Billings Clinic
Collaborators
Healing Dimensions, ACC
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1. Study Identification

Unique Protocol Identification Number
NCT05001399
Brief Title
Feasibility of Using Holographic Memory Resolution® (HMR) in Patients/Clients With Pain
Official Title
Feasibility of Using Holographic Memory Resolution® (HMR) in Patients/Clients With Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
June 29, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Billings Clinic
Collaborators
Healing Dimensions, ACC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Headache, Migraine, Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot and Feasibility Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holographic Memory Resolution® (HMR) Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Holographic Memory Resolution® (HMR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion Rate of an HMR Intervention
Description
The percentage of patients who complete 4 HMR sessions.
Time Frame
Following 4 HMR sessions, approximately 8-9 weeks per participant.
Secondary Outcome Measure Information:
Title
Somatic Symptomatic Scale (SSS-8)
Description
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)].
Time Frame
Baseline, prior to Session 3 ( Day 14-24), prior to Session 4 (8-9 weeks), and 1 month after Session 4.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Gaddy, MD
Organizational Affiliation
Billings Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healing Dimensions ACC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30212442
Citation
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Links:
URL
http://www.nimh.nih.gov/health/topics/index.shtml
Description
National Institute of Mental Health. Mental Health Information. 2020.

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

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