Mechanistic Interventions for Dissociative Disorders

(MIND Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the neurophysiological mechanisms of an intervention to reduce symptoms of dissociation in traumatized people. The intervention will be tested in dissociative traumatized people at two sites: Emory University and University of Pittsburgh. The researchers are interested in whether neural networks associated with attentional control and interoceptive awareness can be enhanced in this population. The researchers propose to evaluate whether different body-focused and non-body focused interventions can change these mechanisms.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Breath Focus, Breathing Exercises, Mindful Breathing, Focused Breathing, No Distractions, Vibration for dissociative disorders?

Research suggests that using vibrations to enhance breath-focused mindfulness can improve attention and body awareness in people with dissociative symptoms, potentially making mindfulness practices more effective for them. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Mindfulness-based interventions, including breath-focused mindfulness and mindful breathing, are generally considered safe for humans, with no significant adverse effects reported in the studies reviewed. ^{1 2 6 7 8}

How does this treatment for dissociative disorders differ from other treatments?

This treatment is unique because it combines breath-focused mindfulness with real-time vibrations delivered through a wearable device, which helps improve attention and body awareness in people with dissociative symptoms. Unlike traditional mindfulness practices, this approach uses external sensory input to enhance the effectiveness of mindfulness for those who struggle with dissociation. ^{1 2 4 7 9}

Research Team

Negar Fani, PhD

Principal Investigator

Emory University

Greg Siegle, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Neurophysiological changes associated with vibroacoustically-augmented breath-focused mindfulness for dissociation: targeting interoception and attention. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Somatization in patients with dissociative disorders. [2022]

4. United States 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. [2023]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Behavior therapy in dissociative convulsions disorder. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation Leads To Increased Dispositional Mindfulness And Interoceptive Awareness Linked To A Reduced Dissociative Tendency. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The efficacies of three relaxation regimens in the treatment of PTSD in Vietnam War veterans. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Computer-Assisted In Sensu Exposure for Posttraumatic Stress Disorder: Development and Evaluation. [2022]