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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Resilient Intrinsic Self-Regulation Strategies in Extremes

• Registration Number: NCT04693728
• Lead Sponsor: Phoenix VA Health Care System

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.

Study Timeline

• Study Start: 2014-08-13
• Primary Completion: 2018-10-30
• Study Completion: 2020-10-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-30
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Intervention	Resilient Intrinsic Self-Regulation Strategies in Extremes	The study intervention arm was a behavioral treatment that consisted of training resilient intrinsic self-regulation strategies to help alleviate chronic pain.

Primary Outcome Measures

Name	Time	Method
RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales	2 weeks	assessment of positive emotional health
PTSD Check List-5	2 weeks	assessment of PTSD symptoms
Insomnia Severity Index	2 weeks	assessment of insomnia symptoms
Pain Catastrophizing Scale	2 weeks	assessment of pain catastrophizing symptoms
Neuropsychological Assessment Battery (NAB) - Word Generation subtest	2 weeks	neuropsychological assessment of executive functions
Patient Health Questionnaire, Depression Scale (PHQ-9)	2 weeks	assessment of depression symptoms
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	2 weeks	neuropsychological assessment of working memory, episodic memory, and complex attention
Generalized Anxiety Disorder (GAD-7)	2 weeks	assessment of anxiety symptoms
Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests	2 weeks	neuropsychological assessement
West Haven-Yale Multidimensional Pain Inventory (WYMPI)	2 weeks	multidimensional assessment of pain
Pain Outcomes Questionnaire (POQ)	2 weeks	multidimensional assessment of pain
Physical Symptoms Scale (PHQ-15)	2 weeks	assessment of physical symptoms

Trial Locations

Locations (1)

Phoenix VA Health Care System; 🇺🇸 Phoenix, Arizona, United States