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Completed

NCT Number: NCT04693728

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

The purpose of this study is to assess the efficacy of a resilience intervention in Veterans with chronic pain compared to wait list control.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Active suicidality of suicidal intent requiring a greater than outpatient level of care (Columbia Suicidality Rating Scale screen, C-SSRS)
  • Active alcohol abuse (Alcohol Use Disorder Identification Test, AUDIT-C)
  • Active psychosis (Psychosis Screener)
  • Current severe disabling illness
  • Inability to participate in a small group interactive setting
  • Inability to meet attendance requirement
  • Neurocognitive conditions other than TBI (e.g. dementia, Parkinsons, stroke)
  • Concurrently receiving Exposure Therapy, Cognitive Behavior Therapy, Acceptance and Commitment Therapy

Treatment and study plan

Resilient Intrinsic Self-Regulation Strategies in Extremes

Behavioral

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

Primary outcomes

  1. RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales

    Time frame: 2 weeks

    assessment of positive emotional health

  2. PTSD Check List-5

    Time frame: 2 weeks

    assessment of PTSD symptoms

  3. Patient Health Questionnaire, Depression Scale (PHQ-9)

    Time frame: 2 weeks

    assessment of depression symptoms

  4. Generalized Anxiety Disorder (GAD-7)

    Time frame: 2 weeks

    assessment of anxiety symptoms

  5. Pain Catastrophizing Scale

    Time frame: 2 weeks

    assessment of pain catastrophizing symptoms

  6. Physical Symptoms Scale (PHQ-15)

    Time frame: 2 weeks

    assessment of physical symptoms

  7. Insomnia Severity Index

    Time frame: 2 weeks

    assessment of insomnia symptoms

  8. West Haven-Yale Multidimensional Pain Inventory (WYMPI)

    Time frame: 2 weeks

    multidimensional assessment of pain

  9. Pain Outcomes Questionnaire (POQ)

    Time frame: 2 weeks

    multidimensional assessment of pain

  10. Neuropsychological Assessment Battery (NAB) - Word Generation subtest

    Time frame: 2 weeks

    neuropsychological assessment of executive functions

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

    Time frame: 2 weeks

    neuropsychological assessement

  12. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Phoenix VA Health Care System

Fed

Registry information

Official study 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

Acronym: RISE

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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