NCT04693728

Brief Summary

The purpose of this study is to assess the efficacy of a resilience intervention in Veterans with chronic pain compared to wait list control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 13, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

4.2 years

First QC Date

December 23, 2020

Last Update Submit

December 30, 2020

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (12)

  • RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales

    assessment of positive emotional health

    2 weeks

  • PTSD Check List-5

    assessment of PTSD symptoms

    2 weeks

  • Patient Health Questionnaire, Depression Scale (PHQ-9)

    assessment of depression symptoms

    2 weeks

  • Generalized Anxiety Disorder (GAD-7)

    assessment of anxiety symptoms

    2 weeks

  • Pain Catastrophizing Scale

    assessment of pain catastrophizing symptoms

    2 weeks

  • Physical Symptoms Scale (PHQ-15)

    assessment of physical symptoms

    2 weeks

  • Insomnia Severity Index

    assessment of insomnia symptoms

    2 weeks

  • West Haven-Yale Multidimensional Pain Inventory (WYMPI)

    multidimensional assessment of pain

    2 weeks

  • Pain Outcomes Questionnaire (POQ)

    multidimensional assessment of pain

    2 weeks

  • Neuropsychological Assessment Battery (NAB) - Word Generation subtest

    neuropsychological assessment of executive functions

    2 weeks

  • Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests

    neuropsychological assessement

    2 weeks

  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    neuropsychological assessment of working memory, episodic memory, and complex attention

    2 weeks

Study Arms (2)

Behavioral Intervention

ACTIVE COMPARATOR

The study intervention arm was a behavioral treatment that consisted of training resilient intrinsic self-regulation strategies to help alleviate chronic pain.

Behavioral: Resilient Intrinsic Self-Regulation Strategies in Extremes

Wait-list with no treatment

NO INTERVENTION

The control comparison arm consisted of a wait-list condition in which participants received no treatment during a time interval comparable to the intervention arm.

Interventions

Resilient Intrinsic Self-Regulation Strategies in ExtremesBEHAVIORAL

The manualized intervention covered resilience strategies organized into four modules: (1) engagement, (2) social relatedness, (3) transformation of pain and (4) building a good life. The modules were delivered in 8 weekly sessions of 90 minutes each.

Also known as: Active Intervention arm
Behavioral Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age 2. United States Veterans from the conflicts of OEF/OIF to Vietnam era 3. Self-identified chronic pain or chart diagnosis of chronic pain

You may not qualify if:

  • Active suicidality of suicidal intent requiring a greater than outpatient level of care (Columbia Suicidality Rating Scale screen, C-SSRS)
  • Active alcohol abuse (Alcohol Use Disorder Identification Test, AUDIT-C)
  • Active psychosis (Psychosis Screener)
  • Current severe disabling illness
  • Inability to participate in a small group interactive setting
  • Inability to meet attendance requirement
  • Neurocognitive conditions other than TBI (e.g. dementia, Parkinsons, stroke)
  • Concurrently receiving Exposure Therapy, Cognitive Behavior Therapy, Acceptance and Commitment Therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

Related Publications (1)

  • Kent M, Mardian AS, Regalado-Hustead ML, Gress-Smith JL, Ciciolla L, Kim JL, Scott BA. Adaptive Homeostatic Strategies of Resilient Intrinsic Self-Regulation in Extremes (RISE): A Randomized Controlled Trial of a Novel Behavioral Treatment for Chronic Pain. Front Psychol. 2021 Apr 12;12:613341. doi: 10.3389/fpsyg.2021.613341. eCollection 2021.

    PMID: 33912102DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martha Kent, PhD

    Phoenix VAHCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

December 23, 2020

First Posted

January 5, 2021

Study Start

August 13, 2014

Primary Completion

October 30, 2018

Study Completion

October 1, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)