Clinical trial NCT05948917: Mind-Body Skills Groups for Incarcerated Men and Women
Official title: Mind-Body Skills Groups for Incarcerated Men and Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Resilience
Keywords: mind-body medicine
resilience
incarcerated
meditation
prisoners
Lead sponsor: The Center for Mind-Body Medicine
Sponsor class: OTHER
Collaborators: name: Herbert Simon Family Foundation
First posted: 2023-07-17
Enrollment: 104
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn about the effectiveness of a Mind-Body Skills Group program for incarcerated participants.The main questions is aims to answer are:

1. Do the mind-body skills groups increase resilience?
2. Do the mind-body skills groups decrease depression, anxiety and/or stress?
3. Do the mind-body skills groups increase participants' belief that they have improved coping skills?
4. Do the mind-body skills groups increase a sense of meaning in life?
5. Do the mind-body skills groups increase a sense of life purpose?
6. Do the mind-body skills groups increase self-esteem in women?
7. Do the mind-body skills groups decrease aggressive responses in men?


Eligibility criteria: Inclusion Criteria:

The inclusion criteria for this study will be English-speaking incarcerated individuals at the Indiana Women's Prison and and at the Plainfield Correctional Facility.

Exclusion Criteria:

1. Having any of the following before the study is completed:

1. a sentence that will end,
2. a scheduled change in security level to a minimum-security prison or,
3. a scheduled work release;

Or 2. Having conduct problems and/or emotional or mental instability that prevents safe and effective participation in the mind-body medicine training program

Primary outcomes:
measure: Change from Baseline on resilience using the Connor-Davidson Resilience Scale (CD-RISC) after the 10-session mind-body skills groups and at 3 month follow-up.
timeFrame: Baseline, 11 weeks, and at 3 month follow-up
Secondary outcomes:
measure: Change from Baseline on depression, anxiety, and stress using the Depression Anxiety and Stress Scale -21 (DASS-21) after the 10-session mind-body skills groups and at 3 month follow-up.
timeFrame: Baseline, 11 weeks, and at 3 month follow-up
measure: Change from Baseline on coping-self efficacy using the Coping Self-Efficacy (CSE) scale after the 10 session mind-body skills groups and at 3 month follow-up
timeFrame: Baseline, 11 weeks, and at 3 month follow-up
measure: Change from Baseline on meaning in life using the Meaning in Life Questionnaire (MLQ) after the 10 session mind-body skills groups and at 3 month follow-up
timeFrame: Baseline, 11 weeks, and at 3 month follow-up
measure: Change from Baseline on purpose in life using the the Life Engagement Test (LET) after the 10 session mind-body skills groups and at 3 month follow-up
timeFrame: Baseline, 11 weeks, and at 3 month follow-up
measure: Change from Baseline on self-esteem (females only) using the Rosenberg Self-Esteem Scale (RSE) after the 10 session mind-body skills groups and at 3 month follow-up
timeFrame: Baseline, 11 weeks, and at 3 month follow-up
measure: Change from Baseline on aggression (males only) using the Aggression Questionnaire (AQ) after the 10 session mind-body skills groups and at 3 month follow-up.
timeFrame: Baseline, 11 weeks, and at 3 month follow-up
Other outcomes:
measure: How the Mind-Body Medicine Skills Groups have Affected the Participants by using Focus Group Interviews
timeFrame: 11 weeks
Locations:
city: Indianapolis
country: United States
facility: Plainfield Correctional Facility
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Women's Prison
state: Indiana
Study officials:
affiliation: The Center for Mind-Body Medicine
name: Julie K Staples, PhD
role: PRINCIPAL_INVESTIGATOR
References: