Back to resultsAdaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE) (RISE)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resilient Intrinsic Self-Regulation Strategies in Extremes
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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:
- 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
Sites / Locations
- Phoenix VA Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Behavioral Intervention
Wait-list with no treatment
Arm Description
The study intervention arm was a behavioral treatment that consisted of training resilient intrinsic self-regulation strategies to help alleviate chronic pain.
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.
Outcomes
Primary Outcome Measures
RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales
assessment of positive emotional health
PTSD Check List-5
assessment of PTSD symptoms
Patient Health Questionnaire, Depression Scale (PHQ-9)
assessment of depression symptoms
Generalized Anxiety Disorder (GAD-7)
assessment of anxiety symptoms
Pain Catastrophizing Scale
assessment of pain catastrophizing symptoms
Physical Symptoms Scale (PHQ-15)
assessment of physical symptoms
Insomnia Severity Index
assessment of insomnia symptoms
West Haven-Yale Multidimensional Pain Inventory (WYMPI)
multidimensional assessment of pain
Pain Outcomes Questionnaire (POQ)
multidimensional assessment of pain
Neuropsychological Assessment Battery (NAB) - Word Generation subtest
neuropsychological assessment of executive functions
Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests
neuropsychological assessement
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
neuropsychological assessment of working memory, episodic memory, and complex attention
Secondary Outcome Measures
Full Information
NCT ID
NCT04693728
First Posted
December 23, 2020
Last Updated
December 30, 2020
Sponsor
Phoenix VA Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT04693728
Brief Title
Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE)
Acronym
RISE
Official Title
Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE): A Controlled Clinical Trial as an Intervention for Chronic Pain From a Homeostatic Perspective
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2014 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix VA Health Care System
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
The purpose of this study is to assess the efficacy of a resilience intervention in Veterans with chronic pain compared to wait list control.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Intervention
Arm Type
Active Comparator
Arm Description
The study intervention arm was a behavioral treatment that consisted of training resilient intrinsic self-regulation strategies to help alleviate chronic pain.
Arm Title
Wait-list with no treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resilient Intrinsic Self-Regulation Strategies in Extremes
Other Intervention Name(s)
Active Intervention arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales
Description
assessment of positive emotional health
Time Frame
2 weeks
Title
PTSD Check List-5
Description
assessment of PTSD symptoms
Time Frame
2 weeks
Title
Patient Health Questionnaire, Depression Scale (PHQ-9)
Description
assessment of depression symptoms
Time Frame
2 weeks
Title
Generalized Anxiety Disorder (GAD-7)
Description
assessment of anxiety symptoms
Time Frame
2 weeks
Title
Pain Catastrophizing Scale
Description
assessment of pain catastrophizing symptoms
Time Frame
2 weeks
Title
Physical Symptoms Scale (PHQ-15)
Description
assessment of physical symptoms
Time Frame
2 weeks
Title
Insomnia Severity Index
Description
assessment of insomnia symptoms
Time Frame
2 weeks
Title
West Haven-Yale Multidimensional Pain Inventory (WYMPI)
Description
multidimensional assessment of pain
Time Frame
2 weeks
Title
Pain Outcomes Questionnaire (POQ)
Description
multidimensional assessment of pain
Time Frame
2 weeks
Title
Neuropsychological Assessment Battery (NAB) - Word Generation subtest
Description
neuropsychological assessment of executive functions
Time Frame
2 weeks
Title
Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests
Description
neuropsychological assessement
Time Frame
2 weeks
Title
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description
neuropsychological assessment of working memory, episodic memory, and complex attention
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Kent, PhD
Organizational Affiliation
Phoenix VAHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33912102
Citation
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.
Results Reference
derived
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Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE)
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