What is the mechanism of action of this treatment?

Common treatments for Prolonged Grief Disorder (PGD) often involve physical and mental exercises that aim to improve mental health and potentially alter neurobiological pathways. Techniques such as Iyengar Yoga, mindfulness meditation, and cognitive-behavioral therapy (CBT) work by promoting relaxation, reducing stress, and enhancing emotional regulation. These practices help in modulating the body's stress response, improving mood, and fostering a sense of well-being. For PGD patients, these treatments are crucial as they address both the psychological and physiological aspects of grief, potentially leading to better mental health outcomes and improved quality of life.

What side effects are associated with this type of intervention?

Common treatments for Prolonged Grief Disorder (PGD) include yoga, mindfulness-based stress reduction (MBSR), and cognitive-behavioral therapy (CBT). These treatments generally have minimal side effects. Yoga and MBSR can sometimes lead to temporary discomfort, such as muscle soreness or emotional distress as individuals confront their grief. CBT may occasionally cause increased anxiety or emotional discomfort as patients work through their grief-related thoughts and feelings. Overall, these treatments are considered safe and beneficial for improving mental health and quality of life in individuals with PGD.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Prolonged Grief Disorder (PGD). Treatments for PGD often involve psychological interventions such as cognitive-behavioral therapy (CBT) and other forms of psychotherapy. Similar to the Iyengar Yoga trial, which focuses on physical and mental exercises to improve mental health, mindfulness-based stress reduction (MBSR) and other mindfulness practices have been studied for their potential benefits in managing symptoms of grief and improving overall mental well-being. These non-pharmacologic approaches aim to alter neurobiological pathways associated with prolonged grief and enhance quality of life.

What other types of research exist?

Promising, novel alternatives to Iyengar Yoga for Prolonged Grief Disorder patients include: 1) Mindfulness-Based Stress Reduction (MBSR), which has been shown to improve psychological distress and quality of life in various populations, including cancer survivors. 2) Cognitive Behavioral Therapy (CBT), which is effective in managing symptoms of depression and anxiety, common in PGD. 3) Tai Chi, which has demonstrated benefits in reducing anxiety and improving overall mental health. 4) Music Therapy, which can improve psychological and physical outcomes in patients with chronic conditions. These alternatives offer a combination of physical and mental exercises aimed at improving mental health and potentially altering neurobiological pathways associated with PGD.

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Iyengar Yoga for Prolonged Grief Disorder (Yoga Trial)

N/A

Waitlist Available

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female greater than or equal to 40 years of age

Presence of PGD

Must not have

Delirium/unstable medical conditions

Serious back, joint or neck injuries within the past 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Iyengar Yoga can help older adults with prolonged grief disorder by changing how their brain and body handle emotions. The study will look at changes in the body and emotions after a period of yoga practice. Iyengar yoga has been shown to effectively reduce distress and improve psychological and physical outcomes in various populations.

Who is the study for?

This trial is for adults aged 40 or older who have been grieving for more than six months due to a loss and are diagnosed with Prolonged Grief Disorder (PGD). They must be able to see and hear well, score above 25 on the ICG grief scale, but can't join if they're at immediate risk of suicide, have certain neurological illnesses or severe psychiatric disorders, currently practice yoga, or have recent serious back injuries.

What is being tested?

The study is testing whether Iyengar Yoga (IY), a form of yoga known for its use of props and attention to detail in poses, can help people with PGD. Participants will either attend IY sessions or partake in social activities as a control group to compare effects on their mental health condition.

What are the potential side effects?

While not explicitly stated for this trial, typical side effects from practicing yoga might include muscle soreness or strain. The socialization control activity is unlikely to cause physical side effects but could potentially affect emotional state.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I have been diagnosed with PGD.

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I can see and hear well enough for daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have delirium or unstable health conditions.

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I have not had serious back, joint, or neck injuries in the last 3 months.

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I have never had seizures, stroke, dementia, severe head injury, brain tumor or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in circulating endocannabinoid concentrations

Secondary study objectives

Change in neural activity measured using Functional magnetic resonance imaging (fMRI)

Inventory of Complicated Grief (ICG) scale score change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Iyengar YogaExperimental Treatment1 Intervention

Participants will engage in 10 weekly IY classes

Group II: Socialization ControlActive Control1 Intervention

Participants will engage in 10 weekly socialization control group sessions

Group III: Healthy Comparison GroupActive Control1 Intervention

A group of participants will also be followed for 10 weeks

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Prolonged Grief Disorder (PGD) often involve physical and mental exercises that aim to improve mental health and potentially alter neurobiological pathways. Techniques such as Iyengar Yoga, mindfulness meditation, and cognitive-behavioral therapy (CBT) work by promoting relaxation, reducing stress, and enhancing emotional regulation. These practices help in modulating the body's stress response, improving mood, and fostering a sense of well-being. For PGD patients, these treatments are crucial as they address both the psychological and physiological aspects of grief, potentially leading to better mental health outcomes and improved quality of life.