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

Phoenix VA Health Care System

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: Resilient Intrinsic Self-Regulation Strategies in Extremes

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04693728

1054

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

88 participants in 2 patient groups

Behavioral Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Resilient Intrinsic Self-Regulation Strategies in Extremes

Wait-list with no treatment

No Intervention group

Description:

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.