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Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04693728
Acronym
RISE
Enrollment
88
Registered
2021-01-05
Start date
2014-08-13
Completion date
2020-10-01
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

BEHAVIORALResilient 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.

Sponsors

Phoenix VA Health Care System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire, Depression Scale (PHQ-9)2 weeksassessment of depression symptoms
Generalized Anxiety Disorder (GAD-7)2 weeksassessment of anxiety symptoms
RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales2 weeksassessment of positive emotional health
PTSD Check List-52 weeksassessment of PTSD symptoms
Pain Catastrophizing Scale2 weeksassessment of pain catastrophizing symptoms
Physical Symptoms Scale (PHQ-15)2 weeksassessment of physical symptoms
Insomnia Severity Index2 weeksassessment of insomnia symptoms
West Haven-Yale Multidimensional Pain Inventory (WYMPI)2 weeksmultidimensional assessment of pain
Pain Outcomes Questionnaire (POQ)2 weeksmultidimensional assessment of pain
Neuropsychological Assessment Battery (NAB) - Word Generation subtest2 weeksneuropsychological assessment of executive functions
Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests2 weeksneuropsychological assessement
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)2 weeksneuropsychological assessment of working memory, episodic memory, and complex attention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026