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

Chronic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693728
• Other study ID #: 1054
• Status: Completed
• Phase: N/A
• Start date: August 13, 2014
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: Phoenix VA Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 1, 2020
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Phoenix VA Health Care System	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

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