NCT05001399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

July 29, 2021

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Completion Rate of an HMR Intervention

    The percentage of patients who complete 4 HMR sessions.

    Following 4 HMR sessions, approximately 8-9 weeks per participant.

Secondary Outcomes (1)

  • Somatic Symptomatic Scale (SSS-8)

    Baseline, prior to Session 3 ( Day 14-24), prior to Session 4 (8-9 weeks), and 1 month after Session 4.

Study Arms (1)

Holographic Memory Resolution® (HMR) Intervention

EXPERIMENTAL

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)

Interventions

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.

Holographic Memory Resolution® (HMR) Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Healing Dimensions ACC

Tucson, Arizona, 85718, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Related Publications (20)

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    PMID: 30212442BACKGROUND
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    PMID: 28810899BACKGROUND
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    PMID: 16172203BACKGROUND
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    PMID: 25856658BACKGROUND
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    PMID: 33400428BACKGROUND
  • 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.

    PMID: 32714478BACKGROUND
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    PMID: 32527685BACKGROUND
  • 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.

    PMID: 16138824BACKGROUND
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    PMID: 24670331BACKGROUND
  • 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.

    PMID: 24276929BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 18752852BACKGROUND
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    BACKGROUND
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    BACKGROUND
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  • 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.

    PMID: 26653052BACKGROUND
  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Chronic PainMigraine DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Mary Gaddy, MD

    Billings Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot and Feasibility Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 12, 2021

Study Start

October 25, 2021

Primary Completion

June 29, 2022

Study Completion

July 18, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations