Mechanistic Interventions for Dissociative Disorders

(MIND Trial)

Overseen By Greg Siegle, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Psychosis, Cognitive impairment, Substance dependence, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for individuals who often feel disconnected from themselves or reality, a condition frequently linked to traumatic experiences. The study examines how various methods, such as focusing on breathing (Breath Focus), reducing screen time (No Distractions), and using vibrations (Vibration), can alter brain functions related to attention and self-awareness. Conducted at Emory University and the University of Pittsburgh, it suits those who have experienced a traumatic event and frequently feel detached or unreal. As an unphased trial, this study provides a unique opportunity to explore innovative methods that could enhance well-being and self-awareness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that vibration treatments can be safe when used correctly. Studies have found that vibrations at certain levels are safe for many hours each day. This suggests the vibration treatment in the trial is likely to be well-tolerated, with few side effects.

For the breath focus treatment, research has demonstrated positive effects on mental health. Mindfulness breathing, a type of breath focus, has been found to reduce depression and anxiety. This indicates that breath focus is likely safe and even helpful for participants.

Overall, previous studies have shown both vibration and breath focus treatments to be safe and beneficial. This makes them promising options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for dissociative disorders because they focus on simple, non-invasive techniques that could offer new ways to manage symptoms. Unlike standard therapies that often involve medication or intensive psychotherapy, these methods—Vibration, Breath Focus, and No Distractions—are designed to be easily accessible and low-cost. Vibration therapy aims to engage the senses and promote grounding, while Breath Focus encourages mindfulness and stress reduction. The No Distractions approach, or "Screens Free," helps participants disconnect from digital devices, potentially reducing anxiety and improving emotional regulation. These innovative approaches could offer alternative or complementary strategies to traditional treatments, making them particularly appealing for individuals seeking less conventional options.

What evidence suggests that this trial's interventions could be effective for dissociative disorders?

Research has shown that vibration therapy, one of the interventions in this trial, can help individuals with dissociative symptoms by improving attention and body awareness. In this trial, some participants will receive vibration therapy alone, while others will receive a combination of vibration and focused breathing. This combination can enhance awareness of bodily sensations and improve attention, while also boosting emotional processing. Another group will practice focused breathing on its own, which has been linked to better management of stress, depression, and anxiety. Focused breathing can also help regulate automatic body functions, like breathing. Different breathing techniques are increasingly used in mental health treatments and show promise for individuals dealing with trauma-related issues. Together, these methods aim to reduce dissociative symptoms by enhancing mental focus and body awareness. ^{1 6 7 8 9}

Who Is on the Research Team?

Negar Fani, PhD

Principal Investigator

Emory University

Greg Siegle, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for people who feel disconnected from themselves (dissociation) after a traumatic event and score at least 7 on the MDI depersonalization scale. Participants must have experienced significant trauma as defined by DSM-5 criteria and be willing to join the study. Those with severe substance dependence, active psychosis, or serious cognitive issues cannot participate.

Inclusion Criteria

A score of 7 or higher on the Multiscale Dissociation Inventory (MDI) depersonalization subscale

I am willing to participate in the study.

Experience of at least one Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criterion A trauma (assessed using the Life Events Checklist)

Exclusion Criteria

Moderate or more severe substance dependence (assessed with the MINI)

Actively psychotic and cognitively compromised individuals (assessed using the Moderate-severe cognitive impairment screening tool (MoCA))

Persons with imminent risk of physical violence to self or others

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive interventions focusing on present-centered awareness and/or body focus, including vibration, breath focus, and screens free interventions

6 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in dissociation, PTSD symptoms, and other psychological measures

6 months

3 visits (in-person or virtual) at 3 and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Breath Focus
• No Distractions
• Vibration

Trial Overview The study tests if focusing on breathing without distractions or using vibration can influence brain networks related to attention control and body awareness in traumatized individuals with dissociative symptoms. It's conducted at Emory University and University of Pittsburgh.

How Is the Trial Designed?

Group I: Vibration With Breath Focus Experimental Treatment 2 Interventions

Participants receiving the vibration with breath focus study intervention.

Group II: Vibration Experimental Treatment 1 Intervention

Participants receiving the vibration study intervention.

Group III: Screens Free Experimental Treatment 1 Intervention

Participants receiving the screens free study intervention.

Group IV: Breath Focus Experimental Treatment 1 Intervention

Participants receiving the breath focus study intervention.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Mindfulness-based interventions have proven effective for many, but they often fall short for individuals with dissociative disorders, highlighting a need for tailored approaches.

By understanding the relational benefits of mindfulness, therapists can adapt practices to help those with dissociative disorders develop mindfulness skills and foster deeper connections, while mindfulness practitioners can learn to accommodate the unique challenges faced by these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Mindfulness can learn about Dissociation and what Dissociation can learn from Mindfulness. Forner, C.[2020]

A 7-week Mindfulness Oriented Meditation (MOM) training significantly reduced dissociative tendencies in healthy individuals compared to a waiting-list control group, indicating its potential efficacy in managing dissociation.

Participants in the MOM group also reported increased mindfulness skills and interoceptive awareness, suggesting that mindfulness practices can foster psychological safety and integration, contrasting with the involuntary nature of dissociation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation Leads To Increased Dispositional Mindfulness And Interoceptive Awareness Linked To A Reduced Dissociative Tendency. D'Antoni, F., Feruglio, S., Matiz, A., et al.[2022]

In a study involving 90 male Vietnam veterans with PTSD, various relaxation techniques were tested, but only 4 out of 21 measures showed any improvement, indicating limited effectiveness of the treatments.

The addition of deep breathing exercises and thermal biofeedback did not significantly enhance the benefits of simple relaxation instructions, suggesting that basic relaxation techniques may be sufficient for mild therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacies of three relaxation regimens in the treatment of PTSD in Vietnam War veterans. Watson, CG., Tuorila, JR., Vickers, KS., et al.[2019]

In a randomized controlled trial involving 100 patients with dissociative disorder, those receiving behavior therapy alongside routine clinical care experienced a significantly greater reduction in the frequency of fits compared to those receiving routine care alone.

Patients in the behavior therapy group also showed more improvement in anxiety and depression levels, indicating that behavioral interventions are more effective than standard clinical practices for managing conversion disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy in dissociative convulsions disorder. Khattak, T., Farooq, S., Jan, B.[2006]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

In a study involving 65 trauma-exposed women, the addition of vibration feedback to breath-focused mindfulness (VBFM) significantly improved interoception, attention, and emotional processing compared to breath-focused mindfulness alone.

The results suggest that VBFM could effectively enhance autonomic regulation and help overcome barriers to trauma treatment, making it a promising option for addressing dissociative symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiological changes associated with vibroacoustically-augmented breath-focused mindfulness for dissociation: targeting interoception and attention. Fani, N., Guelfo, A., La Barrie, DL., et al.[2023]

The MORPHEUS program, designed to assist patients with PTSD during self-administered exposure exercises, was well-accepted and feasible among 26 participants in a 12-week DBT-PTSD treatment, with high ratings for its usefulness in blocking dissociation.

In 82% of cases, using the antidissociative skills provided by MORPHEUS led to a decrease in dissociative symptoms, indicating its potential effectiveness in managing dissociation during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Assisted In Sensu Exposure for Posttraumatic Stress Disorder: Development and Evaluation. Görg, N., Priebe, K., Deuschel, T., et al.[2022]

A pilot study with 44 mindfulness experts using Virtual Reality (VR) for Dialectical Behavioral Therapy (DBT®) mindfulness training showed significant improvements in state of mindfulness and reductions in negative emotions like sadness, anger, and anxiety.

Participants experienced a strong sense of presence in the VR environment and accepted it as a useful tool for mindfulness practice, suggesting that VR could enhance the accessibility and effectiveness of mindfulness training for those who struggle with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. Navarro-Haro, MV., López-Del-Hoyo, Y., Campos, D., et al.[2023]

In a study of 14 psychiatric inpatients with dissociative disorders, 64% were found to have somatization disorder, reporting an average of 12.4 somatic symptoms, which is significantly higher than the 3.1 symptoms reported by a matched comparison group.

There is a strong correlation between the severity of dissociation and the number of somatic symptoms in patients with dissociative disorders, indicating that somatization disorder is a common and serious comorbidity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatization in patients with dissociative disorders. Saxe, GN., Chinman, G., Berkowitz, R., et al.[2022]

Citations

1. withpower.com withpower.com/trial/mechanistic-interventions-for-dissociative-disorders-46bde

Mechanistic Interventions for Dissociative Disorders The results suggest that VBFM could effectively enhance autonomic regulation and help overcome barriers to trauma treatment, making it a promising option for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9819153/

Effect of Mindfulness Breathing Meditation on Depression ... This study showed that mindfulness breathing meditation provides a reduction in scores of stress, depression, and anxiety among university ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0885392419300429

The Effect of 20-Minute Mindful Breathing on the Rapid ... 68.8% of participants in the mindful breathing group experienced improvement in dyspnea at T20 compared to 29.0% of participants in the control group (OR 5.4; ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/capr.12782

Breathing techniques in the treatment of depression: A ... Breathing practices are increasingly being utilised in therapeutic interventions for mental health problems, including depression.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06792760

Additive Effects of Interoceptive Training to Physiotherapy ... Aim 3: To evaluate the additive effects of specific breathing techniques (SBTs) on physiotherapy outcomes in FMD. 3.1 Compare outcomes between patients ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0149763423004220

High ventilation breathwork practices: An overview of their ... Slow-paced breathwork techniques have attracted significant research attention, not only since slow breathing typically heightens heart rate variability ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10897906/

Breathing on the Mind: Treating Dyspnea and Anxiety ... CALM Breathing is a 4-week (8-session) intervention designed to treat dyspnea and anxiety in adults with COPD by targeting dysfunctional breathing behaviors.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02226744

Study to Measure Relaxation From Different Types of ... This 6 week study will compare the effects of different types of breathing. The hypothesis is that different breathing techniques produce ...

9. youtube.com youtube.com/watch?v=DLkoZtiXeqQ

Mindful Breathing: Practicing self-care Take a moment to notice how your breathing is, the breath slow or rapid, is it deep or shallow. Simply notice the breath exactly as it is now.