The Effects and Mechanisms of Brief Mindfulness Meditation and Hypnosis for Pain

NCT05323383 | Recruiting

• 1 other identifier: 2019/HE000347
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effects and mechanisms of 1 x 20-min training in mindfulness meditation and self-hypnosis relative to an inert control. Participants will be randomly assigned to condition. The dual primary outcomes will be pre- to post-training changes in current pain intensity and pain unpleasantness. The active treatments are hypothesized to produce greater reductions in pain outcomes than the control. It is also hypothesized that change in mindfulness will be a mediator specific to mindfulness meditation, while change in affect and decentering will be mediators of the hypnosis condition. Moderators of response will also be explored.

Conditions

Pain; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Current pain intensity

  Numerical rating scale ranging from 0-10

  Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

• Current pain unpleasantness

  Numerical rating scale ranging from 0-10

  Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

Secondary Outcomes (3)

• Mechanism: Mindfulness

  Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

• Mechanism: Positive Affect

  Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

• Mechanism: Decentering

  Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

Study Arms (3)

Mindfulness meditation

EXPERIMENTAL

Participants in the mindfulness meditation condition will practice one, 20-minute breath and body focused meditation.

Behavioral: Mindfulness Meditation

Self-Hypnosis

ACTIVE COMPARATOR

Participants in self-hypnosis will practice one, 20-minute audio-guided hypnosis session with suggestions tailored towards enhancing positive affect and fostering decentering.

Behavioral: Self-hypnosis

Control

OTHER

Participants in the attention control condition will listen to a 20-minute natural history recording.

Other: Attention Control

Interventions

Mindfulness Meditation BEHAVIORAL

Participants in the mindfulness meditation condition will listen to a 20minute guided mindfulness meditation practice that holds the breath and body as the object of meditation.

Mindfulness meditation

Self-hypnosis BEHAVIORAL

Participants in self-hypnosis will listen to a 20-minute audio-guided hypnosis practice with an induction phase, followed by suggestions tailored towards shifts in affect and decentering, and then a re-alerting with post-hypnotic suggestions phase.

Self-Hypnosis

Attention Control OTHER

Control participants will listen to a 20-minute natural history recording which was chosen as past research has found that individuals who listen to it report this to be a neutral, but relaxing passage, and it has been used as an effective control condition in previous research.

Control

Eligibility Criteria

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

You may qualify if:

• Must be 18 years of age;
• Experience chronic or recurrent pain;
• Have access to a computer, phone or tablet with internet capability; and
• Be able to read and understand English.

Sponsors & Collaborators

• The University of Queensland: lead
• University of Washington: collaborator

Study Sites (1)

The University of Queensland

Brisbane, Queensland, 4072, Australia

RECRUITING

MeSH Terms

Conditions

Pain; Chronic Pain

Interventions

Mindfulness; Hypnosis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics

Central Study Contacts

Melissa Day, Ph.D.

CONTACT

+61 7 3365 6421; m.day@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes are assessed remotely via Qualtrics, thus the outcome "assessor" is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind, three-arm, parallel-group randomized design

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 12, 2022
• Study Start: March 24, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-08

Locations

AU (1)