Chronic Pain Skills Study

NCT02653664 | Completed Results DMC

• 1 other identifier: 49799
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 5

Brief Summary

Chronic pain is a significant problem for many Veterans, including new Veterans returning from Iraq and Afghanistan. It is also associated with a number of other significant problems, such as post-traumatic stress disorder and sleep problems. All of these can have significant negative effects of the quality of life of Veterans Three different types of treatment that have been used to treat chronic pain in the general population include self-hypnosis, education about chronic pain, and teaching individuals how to be more mindful. The purpose of this study is to see if these three treatments can help decrease pain in Veterans. Additionally, the researchers want to determine if each of these treatments can help reduce the negative consequences associated with pain, such as changes in mood, sleep, and enjoyment of life. Different types of treatment that include self-hypnosis, education about chronic pain, and learning skills on how to change how a person perceives his/her pain have been used to treat chronic pain the general population. The purpose of this study of this study is to see if these different treatments can help decrease pain and improve quality of life in Veterans with chronic pain, and determine how and why these treatments are effective. A subject must have a Veteran status, have chronic pain, speak English and be at least 18 years old to participate. Sleep Sub-Study Chronic pain and sleep problems are common among Veterans. Study researchers believe the treatment interventions provided as part of the main study will help improve pain and sleep. However, the main study does not include a "real time" measurement of sleep nor does it include any specific strategies for examining the relationship between sleep and pain. Previous research has shown that adequate sleep has been linked to improvements in pain reports. Adversely, sleep deprivation has been found to increase pain perception since it decreases a person's ability to disengage from pain. Therefore, the purpose of this sub-study is to measure sleep in order to learn more about how it interacts with chronic pain. All of the subjects in this sub-study will be Veterans recruited from VA Puget Sound who experience moderate-to-severe chronic pain on a regular basis and who have enrolled in the main study. Study investigators will enroll up to 135 subjects into the sub-study.

Conditions

Chronic Pain

Keywords

Chronic Pain; Sleep

Outcome Measures

Primary Outcomes (1)

• Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment)

  An average of all of the 24-hour ratings (range=1-4 ratings) of average pain intensity was obtained over a period of one week during each assessment period, pre-treatment and post-treatment. Range: 0-10, 0='no pain' and 10 ='pain as bad as you can imagine' The difference between the two average scores from the different assessment periods (pre-treatment and post-treatment) was computed by subtracting the pre-treatment score from the post-treatment score, resulting in a change score. A negative value denotes a decrease in pain intensity between the two assessment periods, whereas a positive value denotes an increase.

  Change in Average Pain Intensity from Pre-Treatment to Immediately Following End of Approximately Eight Weeks of Treatment (Post-Treatment)

Other Outcomes (2)

• Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 3 Months Following End of Treatment

  Change in Average Pain Intensity from Pre-Treatment to 3 Months Following End of Treatment

• Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 6 Months Following End of Treatment

  Change in Average Pain Intensity from Pre-Treatment to 6 Months Following End of Treatment

Study Arms (3)

Condition #1: PsychoEducation (ED)

EXPERIMENTAL

Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to.

Behavioral: PsychoEducation

Condition #2:Self-Hypnosis Training (HYP)

EXPERIMENTAL

In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality).

Behavioral: Self-Hypnosis Training

Condition #3: Mindfulness Meditation (MM)

EXPERIMENTAL

In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice.

Behavioral: Mindfulness Meditation

Interventions

PsychoEducation BEHAVIORAL

Condition #1

Condition #1: PsychoEducation (ED)

Self-Hypnosis Training BEHAVIORAL

Condition #2

Condition #2:Self-Hypnosis Training (HYP)

Mindfulness Meditation BEHAVIORAL

Condition #3

Condition #3: Mindfulness Meditation (MM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• Veteran eligible for services through Veteran Health Affairs;
• experience moderate to severe chronic pain on a regular basis; and
• able to read, speak and understand English.

You may not qualify if:

• severe cognitive impairment;
• current or history of psychiatric or behavioral issues that require immediate attention and/or prevent the subject from participating effectively in the study;
• reported use of a high dose of an opioid(s).

Sponsors & Collaborators

• University of Washington: lead
• VA Puget Sound Health Care System: collaborator
• Washington State University: collaborator

Study Sites (5)

University of Washington, Ninth and Jefferson Building

Seattle, Washington, 98104, United States

Location

University of Washington- Harborview Medical Center

Seattle, Washington, 98104, United States

Location

VA Puget Sound Health Care System, Seattle Division

Seattle, Washington, 98108, United States

Location

University of Washington, Integrated Brain Imaging Center

Seattle, Washington, 98195, United States

Location

VA Puget Sound Health Care System, American Lake

Tacoma, Washington, 98493, United States

Location

Related Publications (7)

• Jensen MP, Ciol MA, Gertz KJ, Ehde DM, Hakimian S, Day MA, Pettet MW, Turner AP, Sarabosing CG, Williams RM. Potential mediators of the effects of clinical hypnosis, mindfulness meditation, and pain education on chronic pain in Veterans. J Pain. 2026 Jan 6:106176. doi: 10.1016/j.jpain.2025.106176. Online ahead of print.

  PMID: 41506354 DERIVED

• Ho EJ, Turner AP, Jensen MP, Day MA, Ehde DM, Anastas TM, Williams RM. Positive impacts of psychological pain treatments: Supplementary analyses of a randomized clinical trial. Rehabil Psychol. 2025 Feb;70(1):36-45. doi: 10.1037/rep0000557. Epub 2024 Mar 28.

  PMID: 38546554 DERIVED

• Anastas TM, Turner AP, Ho EJ, Day MA, Ehde DM, Jensen MP, Williams RM. Evaluating the benefits of a second pain treatment following a clinical trial. Rehabil Psychol. 2024 Feb;69(1):74-83. doi: 10.1037/rep0000510. Epub 2023 Jun 19.

  PMID: 37338442 DERIVED

• Turner AP, Edwards KA, Jensen MP, Ehde DM, Day MA, Williams RM. Effects of hypnosis, mindfulness meditation, and education for chronic pain on substance use in veterans: A supplementary analysis of a randomized clinical trial. Rehabil Psychol. 2023 Aug;68(3):261-270. doi: 10.1037/rep0000507. Epub 2023 Jun 8.

  PMID: 37289535 DERIVED

• Williams RM, Day MA, Ehde DM, Turner AP, Ciol MA, Gertz KJ, Patterson D, Hakimian S, Suri P, Jensen MP. Effects of hypnosis vs mindfulness meditation vs education on chronic pain intensity and secondary outcomes in veterans: a randomized clinical trial. Pain. 2022 Oct 1;163(10):1905-1918. doi: 10.1097/j.pain.0000000000002586. Epub 2022 Jan 25.

  PMID: 35082248 DERIVED

• Turner AP, Jensen MP, Day MA, Williams RM. Behavioral activation and behavioral inhibition: An examination of function in chronic pain. Rehabil Psychol. 2021 Feb;66(1):57-64. doi: 10.1037/rep0000316. Epub 2020 Mar 9.

  PMID: 32150432 DERIVED

• Williams RM, Ehde DM, Day M, Turner AP, Hakimian S, Gertz K, Ciol M, McCall A, Kincaid C, Pettet MW, Patterson D, Suri P, Jensen MP. The chronic pain skills study: Protocol for a randomized controlled trial comparing hypnosis, mindfulness meditation and pain education in Veterans. Contemp Clin Trials. 2020 Mar;90:105935. doi: 10.1016/j.cct.2020.105935. Epub 2020 Jan 9.

  PMID: 31926321 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Mark Jensen
• Organization: University of Washington

mjensen@uw.edu

206-543-3185

Study Officials

• Mark Jensen, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Rhonda Williams, PhD

  VA Puget Sound Healthcare System (VAPSHCS)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: January 12, 2016
• Study Start: October 9, 2015
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: October 29, 2021
• Results First Posted: October 18, 2021

Record last verified: 2021-10

Locations

US (5)