Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE) (RISE)

Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE): A Controlled Clinical Trial as an Intervention for Chronic Pain From a Homeostatic Perspective

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Resilient Intrinsic Self-Regulation Strategies in Extremes

Detailed Description

After being consented and screened for eligibility, participants completed baseline assessments and then were randomized to either the study intervention or wait list control. Participants who were randomized to the study intervention completed post testing assessment measures within two weeks of the final treatment. Participants who were randomized to waitlist conditions completed post testing assessment measures within 2 weeks of the end of the waitlist condition and then subsequently received the study intervention.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Phoenix VA Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1.18-80 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Behavioral Intervention; 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; 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.; Other Names: Active Intervention arm
No Intervention: Wait-list with no treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Phoenix VA Health Care System
• Investigators: Principal Investigator: Martha Kent, PhD, Phoenix VAHCS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2014
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1054

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