Clinical trial NCT04693728: Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Phoenix VA Health Care System
Sponsor class: FED
First posted: 2021-01-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales
timeFrame: 2 weeks
measure: PTSD Check List-5
timeFrame: 2 weeks
measure: Patient Health Questionnaire, Depression Scale (PHQ-9)
timeFrame: 2 weeks
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 2 weeks
measure: Pain Catastrophizing Scale
timeFrame: 2 weeks
measure: Physical Symptoms Scale (PHQ-15)
timeFrame: 2 weeks
measure: Insomnia Severity Index
timeFrame: 2 weeks
measure: West Haven-Yale Multidimensional Pain Inventory (WYMPI)
timeFrame: 2 weeks
measure: Pain Outcomes Questionnaire (POQ)
timeFrame: 2 weeks
measure: Neuropsychological Assessment Battery (NAB) - Word Generation subtest
timeFrame: 2 weeks
measure: Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests
timeFrame: 2 weeks
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System
state: Arizona
Study officials:
affiliation: Phoenix VAHCS
name: Martha Kent, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.