Clinical trial NCT06669442: The Effectiveness of Guided Imagery on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder
Official title: The Effectiveness of Guided Imagery, a Mindfulness Technique, on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder PTSD
Keywords: Guided Imagery
Mindfulness
Post Traumatic Stress Disorder
Adult Women
Women
Stress Disorders, Post-Traumatic
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Post-Traumatic Stress Disorder (PTSD) affects a significant portion of the population, with about 13 million Americans diagnosed in 2020. Women are twice as likely to have PTSD than men. PTSD will affect 8%, or 8 out of every 100 women, at some stage in their lives. This study will check the effects of guided imagery mindfulness on PCL-5 scores in adult women with PTSD. Participants in this study will complete a PCL-5 pre-test and post-test to check PTSD symptoms before and after 6-weeks of mindfulness sessions. Each participant will engage in 15-minute sessions of guided imagery mindfulness once a week for 6 weeks. Before and after PCL-5 scores will show the effect of guided imagery mindfulness on PTSD symptom severity.

Detailed description: Background: Post-Traumatic Stress Disorder (PTSD) affects a significant portion of the population, with approximately 13 million Americans diagnosed in 2020. Women are twice as likely to have PTSD than men. PTSD will affect 8%, or 8 out of every 100 women, at some stage in their lives.

Purpose: This project aims to investigate the effectiveness of guided imagery, a mindfulness technique, on PCL-5 scores in adult women with PTSD.

Theoretical Framework: The Cognitive model of PTSD was developed to explain why some people do not recover after trauma and to identify maintaining factors that can be modified in treatment. This model suggests negative appraisals, disjointed trauma memories, and unhelpful coping strategies maintain PTSD.

Methods: Participants in this qualitative study will complete pre- and post-intervention PCL--5 questionnaires, a validated 20-item structured interview designed to assess PTSD symptoms. They will also engage in 15-minute sessions of guided imagery mindfulness interventions. Post-intervention, participants will complete a second PCL-5 questionnaire to evaluate any changes in symptom severity.

Results: Analysis of PCL-5 scores will provide insight into the effect of guided imagery mindfulness interventions on PTSD symptom severity.

Conclusions: Mindfulness has the potential to serve as a viable alternative or supplemental intervention for women diagnosed with PTSD. Through exploring the potential benefits of mindfulness-based interventions in managing PTSD symptoms, this study seeks to aid in the advancement of more effective treatment options.

Eligibility criteria: Inclusion Criteria:

* Females
* PTSD diagnosis (ICD 10: F43.1)
* 18 to 99 years old
* Not pregnant
* No suicidal ideations
* No homicidal ideations
* No audio-visual hallucinations
* A mobile device, smart phone, laptop
* Resident at the Residential Treatment Facility

Exclusion Criteria:

* Males
* Under 18 years old
* Above 99 years old
* Pregnant women
* Active suicidal ideation
* Active homicidal ideation
* Do not have mobile device
* Active audio-visual hallucinations

Primary outcomes:
measure: Change from Baseline PTSD Symptom Severity Using PTSD Checklist for DSM-5 (PCL-5) Scores at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jessie Trice Community Health Systems
state: Florida
Study officials:
References:
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