Chronic PainRISENCT04693728
Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE)
A study testing Resilient Intrinsic Self-Regulation Strategies in Extremes in people with Chronic Pain, run by Phoenix VA Health Care System at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Resilient Intrinsic Self-Regulation Strategies in Extremes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2014to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Phoenix VA Health Care System
Phoenix, Arizona, 85012
About this study
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
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.
- Conditions
- Chronic Pain
- Being tested
- Resilient Intrinsic Self-Regulation Strategies in Extremes
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilient Intrinsic Self-Regulation Strategies in ExtremesBehavioural
Also called Active Intervention arm
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Active comparator | The study intervention arm was a behavioral treatment that consisted of training resilient intrinsic self-regulation strategies to help alleviate chronic pain. Receives: Behavioral: Resilient Intrinsic Self-Regulation Strategies in Extremes |
| Wait-list with no treatment | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales
assessment of positive emotional health
Measured: 2 weeks
PTSD Check List-5
assessment of PTSD symptoms
Measured: 2 weeks
Patient Health Questionnaire, Depression Scale (PHQ-9)
assessment of depression symptoms
Measured: 2 weeks
Generalized Anxiety Disorder (GAD-7)
assessment of anxiety symptoms
Measured: 2 weeks
Pain Catastrophizing Scale
assessment of pain catastrophizing symptoms
Measured: 2 weeks
Physical Symptoms Scale (PHQ-15)
assessment of physical symptoms
Measured: 2 weeks
Insomnia Severity Index
assessment of insomnia symptoms
Measured: 2 weeks
West Haven-Yale Multidimensional Pain Inventory (WYMPI)
multidimensional assessment of pain
Measured: 2 weeks
Pain Outcomes Questionnaire (POQ)
multidimensional assessment of pain
Measured: 2 weeks
Neuropsychological Assessment Battery (NAB) - Word Generation subtest
neuropsychological assessment of executive functions
Measured: 2 weeks
Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests
neuropsychological assessement
Measured: 2 weeks
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
neuropsychological assessment of working memory, episodic memory, and complex attention
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start13 Aug 2014
- Primary completion30 Oct 2018
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix VA Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Aram Mardian, Phoenix VA Health Care System
- Investigators
- Martha Kent, PhD, Principal investigator, Phoenix VAHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693728
- Sponsor's protocol ID
- 1054
- Acronym
- RISE
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04693728
- Acronym / sponsor ID
- RISE / 1054
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Phoenix VA Health Care SystemUS federal agency
- Study start
- 13 Aug 2014 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Active comparator | Behavioral: Resilient Intrinsic Self-Regulation Strategies in ExtremesThe study intervention arm was a behavioral treatment that consisted of training resilient intrinsic self-regulation strategies to help alleviate chronic pain. |
| Wait-list with no treatment | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilient Intrinsic Self-Regulation Strategies in ExtremesAlso: Active Intervention armThe 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. | Behavioural | Behavioral Intervention |
Primary outcome
RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales
Time frame: 2 weeks
assessment of positive emotional health
PTSD Check List-5
Time frame: 2 weeks
assessment of PTSD symptoms
Patient Health Questionnaire, Depression Scale (PHQ-9)
Time frame: 2 weeks
assessment of depression symptoms
Generalized Anxiety Disorder (GAD-7)
Time frame: 2 weeks
assessment of anxiety symptoms
Pain Catastrophizing Scale
Time frame: 2 weeks
assessment of pain catastrophizing symptoms
Physical Symptoms Scale (PHQ-15)
Time frame: 2 weeks
assessment of physical symptoms
Insomnia Severity Index
Time frame: 2 weeks
assessment of insomnia symptoms
West Haven-Yale Multidimensional Pain Inventory (WYMPI)
Time frame: 2 weeks
multidimensional assessment of pain
Pain Outcomes Questionnaire (POQ)
Time frame: 2 weeks
multidimensional assessment of pain
Neuropsychological Assessment Battery (NAB) - Word Generation subtest
Time frame: 2 weeks
neuropsychological assessment of executive functions
Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests
Time frame: 2 weeks
neuropsychological assessement
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 2 weeks
neuropsychological assessment of working memory, episodic memory, and complex attention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 33912102Kent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Kent, PhD principal investigator
Phoenix VAHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilient Intrinsic Self-Regulation Strategies in Extremes in people with Chronic Pain, run by Phoenix VA Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales (time frame: 2 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.