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Clinical Trials/NCT06669442
NCT06669442CompletedNot Applicable

The Effectiveness of Guided Imagery, a Mindfulness Technique, on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder

Nova Southeastern University1 site in 1 country15 target enrollmentStarted: February 19, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Change from Baseline PTSD Symptom Severity Using PTSD Checklist for DSM-5 (PCL-5) Scores at 6 weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

  • •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

Arms & Interventions

Guided Imagery Mindfulness

Experimental

Mindfulness-based interventions (MBIs), such as guided imagery, emerge as promising alternatives for managing PTSD. Mindfulness necessitates participant training to maintain present awareness amidst wandering thoughts, fostering an attitude of non-judgmental acceptance towards thoughts and emotions. Mindfulness encourages, being present in the moment and supports emotional control.

Intervention: Guided Imagery (Behavioral)

Outcomes

Primary Outcomes

Change from Baseline PTSD Symptom Severity Using PTSD Checklist for DSM-5 (PCL-5) Scores at 6 weeks

Time Frame: 6 weeks

PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Participants rate how bothered they have been by each of 20 items in the past month on a 5- point Likert scale ranging from 0-4. Items are summed to provide a total severity score (range = 0-80). 0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely Range: 0 (best outcome) to 80 (worst outcome)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kellie-Ann Kerr

Principal Investigator

Nova Southeastern University

Study Sites (1)

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