Recruiting

Self-Hypnosis & Mindfulness

Sponsor:

VA Puget Sound Health Care System

Code:

NCT03558594

Conditions

Pain Related to Cancer

Cancer of Head and Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypnosis

Mindfulness

Study Details

Brief summary:

The research study involves an open label trial (i.e., participant selects one of 2 interventions) to determine whether Veterans engaged in treatment for head and/or neck cancers find either of the two available behavioral treatments for pain (Self-Hypnosis or Mindfulness) helpful in managing pain, and if the study's delivery modality (providing audio recordings and workbooks for home use) is acceptable and feasible. If neither of the 2 interventions seems appealing, the participant can participate in the study by completing the study assessments only (this option is usual care); however, the participant will not receive the study materials or one-on-one appointments with the study clinician.

Conditions

Pain Related to Cancer

Cancer of Head and Neck

Study ID

NCT03558594

Start date

Jul 31, 2018

Status verified date

Aug, 2019

Completion date

Jul 28, 2020

Anticipated

Primary completion date

Jul 28, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Veteran status (defined as prior service in the US Armed Forces and eligible to receive health care services through Veterans Health Affairs)
2. 18 years of age or older
3. Undergoing head and/or neck cancer treatment at the VAPSHCS in Seattle.
4. Less than two (2) errors on the 6-item Cognitive Screener
5. Able to read, speak, and understand English

Exclusion Criteria:

1. Primary psychotic or major thought disorder as listed in participant's medical record or self-reported
2. Psychiatric or behavioral conditions in which symptoms were unstable or severe (e.g., current delirium, mania, psychosis, suicidal ideation, homicidal ideation, active substance use disorder, psychiatric hospitalization) as listed in participant's medical record or self-reported within the past six months
3. Hospitalization for psychiatric reasons involving psychosis other than suicidal ideation, homicidal ideation, and/or PTSD as noted in chart (within the past 5 years).
4. Difficulties or limitations communicating over the telephone

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hypnosis

Participant will have one brief meeting with a clinician in which they will learn about hypnosis and be provided with an informational booklet and with audiorecordings of hypnosis exercises. Participants will be encouraged to listen to the hypnosis recordings as much as they would like, whenever they would like to listen. The recordings are short inductions 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 audio recordings 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).

experimental: Mindfulness

Participant will have one brief meeting with a clinician in which they will learn about mindfulness meditation and be provided with an informational booklet and with audio recordings of mindfulness exercises. Participants will learn Vipassana meditation by listening to audio recordings, 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.Participants will be encouraged to listen to the meditation recordings as much as they would like, whenever they would like to listen.

no intervention: No intervention

Participants will enroll in the study, but do not select a study intervention. They will complete study assessments on the same schedule as those participants who select either experimental arm.

Interventions

Hypnosis

Behavioral Condition

Mindfulness

Behavioral Condition

Primary outcome measure

  • Change in Self-Reported Pain Intensity from Pre to post-treatment [ Time Frame: Baseline and 4 weeks post-baseline ]

Central Contacts and Locations

Central contacts

Carrie Kincaid, BA

206-277-3959carrie.kincaid@va.gov

Locations

VA Puget Sound Heathcare System

Recruiting

Seattle, Washington, United States, 98108

More Information

Sponsor

VA Puget Sound Health Care System

Last update posted

Aug 28, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Puget Sound Health Care System on 2019-08-28.