Mindfulness Training for Anxiety

(ITEM Trial)

Overseen By Jafer Vazquez Alcaraz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Veterans Medical Research Foundation

Disqualifiers: Bipolar, Psychotic illness, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

48 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

Veteran status

ASI-3 score of 23 or higher

Clinically meaningful distress/impairment related to an emotional or somatic complaint as determined by a Clinical Global Impression Scale (CGI) of 4 or greater

Exclusion Criteria

I regularly practice meditation or am being treated for an AS-related condition.

Serious mental illness, including bipolar disorder or psychotic illness

Current, untreated alcohol or substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Interoceptive Training Enhanced Mindfulness (ITEM) or Interoceptive Exposure (IE) in six one-on-one sessions delivered via telehealth

6 weeks

6 sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Interoceptive Training Enhanced Mindfulness

Trial Overview

The study is testing two approaches to help with allergic reactions and anxiety: mindfulness training versus interoceptive exposure. It's designed to see if these methods are practical and acceptable as treatments for people who are very sensitive to the sensations of anxiety.

How Is the Trial Designed?

Group I: Interoceptive Training Enhanced Mindfulness (ITEM) Experimental Treatment 1 Intervention

Brief mindfulness training focused on management of unwanted internal sensations

Group II: Interoceptive Exposure (IE) Active Control 1 Intervention

Cognitive behavioral intervention featuring systematic exposure to unwanted internal sensations

Who Is Running the Clinical Trial?

Veterans Medical Research Foundation

Lead Sponsor

Trials

46

Recruited

5,100+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

Citations

1.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT06786572

Interoceptive Training Enhanced Mindfulness

Summary. This pilot randomized controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12061673/

Mindfulness teacher training enhances interoceptive ...

We investigated the impact of a mindfulness teacher training (MTT) program on emotional distress and IA in individuals training to become mindfulness teachers.

3.

withpower.com

withpower.com/trial/mindfulness-training-for-anxiety-c8f68

Mindfulness Training for Anxiety (ITEM Trial)

This pilot randomized controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability as an ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06695715

Effects of HRV Biofeedback, Interoceptive Training, and ...

In fact, recent studies have shown that interoception training can improve mental health outcomes, including emotional regulation and stress management, and it ...

5.

biorxiv.org

biorxiv.org/content/10.1101/2025.06.16.659873v1.full-text

Interoceptive training enhances emotional awareness and ...

Interoceptive training represents a powerful tool for refining awareness of internal states, enhancing attentional control, and optimizing emotional processing.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6775765/

Immediate effects of interoceptive awareness training ...

Measures. Data were collected to assess interoceptive awareness and mindfulness skills, emotion regulation, psychological distress, and substance use outcomes.