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CompletedNCT04693728RISEUpdated Jan 5, 2021

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

An interventional study of Resilient Intrinsic Self-Regulation Strategies in Extremes in Chronic Pain, sponsored by Phoenix VA Health Care System. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Phoenix VA Health Care System · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 4 months after the study started (first participant enrolled Aug 2014, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Chronic Pain

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In context

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's enrollment of 88 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Phoenix VA Health Care System is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
88 participants (actual)

Study arms

  • 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

  • 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.

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.

    Also known as: Active Intervention arm

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What researchers measure

Primary outcomes

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

    assessment of positive emotional health

    Time frame: 2 weeks

  2. PTSD Check List-5

    assessment of PTSD symptoms

    Time frame: 2 weeks

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

    assessment of depression symptoms

    Time frame: 2 weeks

  4. Generalized Anxiety Disorder (GAD-7)

    assessment of anxiety symptoms

    Time frame: 2 weeks

  5. Pain Catastrophizing Scale

    assessment of pain catastrophizing symptoms

    Time frame: 2 weeks

  6. Physical Symptoms Scale (PHQ-15)

    assessment of physical symptoms

    Time frame: 2 weeks

  7. Insomnia Severity Index

    assessment of insomnia symptoms

    Time frame: 2 weeks

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

    multidimensional assessment of pain

    Time frame: 2 weeks

  9. Pain Outcomes Questionnaire (POQ)

    multidimensional assessment of pain

    Time frame: 2 weeks

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

    neuropsychological assessment of executive functions

    Time frame: 2 weeks

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

    neuropsychological assessement

    Time frame: 2 weeks

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

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

    Time frame: 2 weeks

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Study locations

1 site
  • Phoenix VA Health Care System
    Phoenix, Arizona 85012, United States
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References and documents

Publications

  • 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. PubMed 33912102 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04693728
Lead sponsor
Phoenix VA Health Care System
Responsible party
Aram Mardian (Senior Research Scientist, Phoenix VA Health Care System) — Principal investigator
First posted
Jan 5, 2021
Start date
Aug 13, 2014
Primary completion
Oct 30, 2018
Completion
Oct 1, 2020
Last update
Jan 5, 2021

Study contacts

Martha Kent, PhD
principal investigator · Phoenix VAHCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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