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

Sponsor
Phoenix VA Health Care System (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT04693728
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
73.6
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Resilient Intrinsic Self-Regulation Strategies in Extremes
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 13, 2014
Actual Primary Completion Date :
Oct 30, 2018
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Behavioral Intervention

The study intervention arm was a behavioral treatment that consisted of training resilient intrinsic self-regulation strategies to help alleviate chronic pain.

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.
Other Names:
  • Active Intervention arm

    		•
    No Intervention: Wait-list with no treatment

    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.

    Outcome Measures

    Primary Outcome Measures

    1. RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales [2 weeks]

      assessment of positive emotional health

    2. PTSD Check List-5 [2 weeks]

      assessment of PTSD symptoms

    3. Patient Health Questionnaire, Depression Scale (PHQ-9) [2 weeks]

      assessment of depression symptoms

    4. Generalized Anxiety Disorder (GAD-7) [2 weeks]

      assessment of anxiety symptoms

    5. Pain Catastrophizing Scale [2 weeks]

      assessment of pain catastrophizing symptoms

    6. Physical Symptoms Scale (PHQ-15) [2 weeks]

      assessment of physical symptoms

    7. Insomnia Severity Index [2 weeks]

      assessment of insomnia symptoms

    8. West Haven-Yale Multidimensional Pain Inventory (WYMPI) [2 weeks]

      multidimensional assessment of pain

    9. Pain Outcomes Questionnaire (POQ) [2 weeks]

      multidimensional assessment of pain

    10. Neuropsychological Assessment Battery (NAB) - Word Generation subtest [2 weeks]

      neuropsychological assessment of executive functions

    11. Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests [2 weeks]

      neuropsychological assessement

    12. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [2 weeks]

      neuropsychological assessment of working memory, episodic memory, and complex attention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix VA Health Care System Phoenix Arizona United States 85012

    Sponsors and Collaborators

    • Phoenix VA Health Care System

    Investigators

    • Principal Investigator: Martha Kent, PhD, Phoenix VAHCS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aram Mardian, Senior Research Scientist, Phoenix VA Health Care System
    ClinicalTrials.gov Identifier:
    NCT04693728
    Other Study ID Numbers:
    • 1054
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chronic Pain

    Study Results

    No Results Posted as of Jan 5, 2021