Mindfulness Training for Anxiety
(ITEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two methods to help manage anxiety. One group will try a new mindfulness training called Interoceptive Training Enhanced Mindfulness, which focuses on handling uncomfortable internal feelings. The other group will use a method that gradually exposes them to these feelings to reduce anxiety. The trial seeks veterans who experience anxiety that affects their daily life, can speak English, and have internet access. Veterans with frequent anxiety issues may find this trial suitable. As an unphased trial, it offers veterans the chance to explore innovative anxiety management techniques.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that mindfulness training, such as the Interoceptive Training Enhanced Mindfulness (ITEM) used in the study, is generally easy for people to handle. Studies have found that mindfulness techniques can improve emotion management and reduce stress without major side effects, indicating safety for most individuals.
Interoceptive Exposure (IE), a form of cognitive behavioral therapy, has been safely used for many years to help people confront fears and manage anxiety. Although some initial discomfort may occur, these feelings typically decrease as therapy continues.
Both methods aim to manage anxiety by teaching better awareness and control over internal feelings. So far, they are considered safe for participants.12345Why are researchers excited about this trial?
Unlike the standard options for anxiety, which often include medications or traditional cognitive-behavioral therapy (CBT), Interoceptive Training Enhanced Mindfulness (ITEM) combines mindfulness techniques with a focus on managing internal sensations. This approach is unique because it helps individuals directly address and adapt to uncomfortable internal feelings, which can be a core part of anxiety. Researchers are excited about ITEM because it emphasizes self-awareness and resilience, potentially offering a more holistic and empowering way to manage anxiety symptoms without relying solely on external interventions.
What evidence suggests that this trial's treatments could be effective for anxiety?
Research has shown that training to be more aware of the body's internal signals can enhance emotional understanding and stress management. This training improves focus and helps manage emotions more effectively. These benefits suggest its potential for treating anxiety by aiding in the understanding and control of internal feelings. In this trial, participants will receive either Interoceptive Training Enhanced Mindfulness (ITEM) or Interoceptive Exposure (IE). Mindfulness training, such as ITEM, has been linked to reduced emotional distress, which can also alleviate anxiety. Overall, early research suggests that combining mindfulness with body awareness training might be a promising approach to managing anxiety symptoms.12346
Are You a Good Fit for This Trial?
This trial is for veterans with a high level of anxiety sensitivity, who can read and speak English, have significant distress related to emotional or physical complaints, and have internet access. They must not be currently meditating or in treatment for anxiety-related conditions, nor should they have serious mental illness, untreated substance issues, severe suicidality, or cognitive dysfunction.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Interoceptive Training Enhanced Mindfulness (ITEM) or Interoceptive Exposure (IE) in six one-on-one sessions delivered via telehealth
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Interoceptive Training Enhanced Mindfulness
Find a Clinic Near You
Who Is Running the Clinical Trial?
Veterans Medical Research Foundation
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator