- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06669442
The Effectiveness of Guided Imagery on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder (PTSD)
The Effectiveness of Guided Imagery, a Mindfulness Technique, on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33142
- Jessie Trice Community Health Systems
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Guided Imagery Mindfulness
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.
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Guided imagery is a mindfulness based therapeutic technique that involves utilizing positive imagery allowing one to cultivate awareness of their mental state and shift their attention from ruminative thought patterns to the present moment.
Evidence-based research shows that benefits of Guided imagery include relaxation, stress reduction, anxiety reduction, immune system enhancement, and overall well-being.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from Baseline PTSD Symptom Severity Using PTSD Checklist for DSM-5 (PCL-5) Scores at 6 weeks
Time Frame: 6 weeks
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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) |
6 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Waldron EM, Burnett-Zeigler I. The impact of participation in a mindfulness-based intervention on posttraumatic stress symptomatology among Black women: A pilot study. Psychol Trauma. 2022 Jan;14(1):29-37. doi: 10.1037/tra0001107. Epub 2021 Aug 26.
- Saban KL, Collins EG, Mathews HL, Bryant FB, Tell D, Gonzalez B, Bhoopalam S, Chroniak CP, Janusek LW. Impact of a Mindfulness-Based Stress Reduction Program on Psychological Well-Being, Cortisol, and Inflammation in Women Veterans. J Gen Intern Med. 2022 Sep;37(Suppl 3):751-761. doi: 10.1007/s11606-022-07584-4. Epub 2022 Aug 30.
- Roberts NP, Kitchiner NJ, Lewis CE, Downes AJ, Bisson JI. Psychometric properties of the PTSD Checklist for DSM-5 in a sample of trauma exposed mental health service users. Eur J Psychotraumatol. 2021 Jan 26;12(1):1863578. doi: 10.1080/20008198.2020.1863578. eCollection 2021.
- McNicholas C, Lennox L, Woodcock T, Bell D, Reed JE. Evolving quality improvement support strategies to improve Plan-Do-Study-Act cycle fidelity: a retrospective mixed-methods study. BMJ Qual Saf. 2019 May;28(5):356-365. doi: 10.1136/bmjqs-2017-007605. Epub 2019 Mar 18.
- Kozlov E, Bantum E, Pagano I, Walser R, Ramsey K, Taylor K, Jaworski B, Owen J. The Reach, Use, and Impact of a Free mHealth Mindfulness App in the General Population: Mobile Data Analysis. JMIR Ment Health. 2020 Nov 27;7(11):e23377. doi: 10.2196/23377.
- Krau SD. The Multiple Uses of Guided Imagery. Nurs Clin North Am. 2020 Dec;55(4):467-474. doi: 10.1016/j.cnur.2020.06.013. Epub 2020 Oct 14.
- Kachadourian LK, Harpaz-Rotem I, Tsai J, Southwick S, Pietrzak RH. Mindfulness as a mediator between trauma exposure and mental health outcomes: Results from the National Health and Resilience in Veterans Study. Psychol Trauma. 2021 Feb;13(2):223-230. doi: 10.1037/tra0000995. Epub 2021 Jan 21.
- Haider T, Dai CL, Sharma M. Efficacy of Meditation-Based Interventions on Post-Traumatic Stress Disorder (PTSD) Among Veterans: A Narrative Review. Adv Mind Body Med. 2021 Winter;35(1):16-24.
- Gibson J. Trauma, early life stress, and mindfulness in adulthood. BMC Psychol. 2024 Feb 14;12(1):71. doi: 10.1186/s40359-024-01563-6.
- Ehlers A, Grey N, Wild J, Stott R, Liness S, Deale A, Handley R, Albert I, Cullen D, Hackmann A, Manley J, McManus F, Brady F, Salkovskis P, Clark DM. Implementation of cognitive therapy for PTSD in routine clinical care: effectiveness and moderators of outcome in a consecutive sample. Behav Res Ther. 2013 Nov;51(11):742-52. doi: 10.1016/j.brat.2013.08.006. Epub 2013 Sep 10.
- Beierl ET, Bollinghaus I, Clark DM, Glucksman E, Ehlers A. Cognitive paths from trauma to posttraumatic stress disorder: a prospective study of Ehlers and Clark's model in survivors of assaults or road traffic collisions. Psychol Med. 2020 Oct;50(13):2172-2181. doi: 10.1017/S0033291719002253. Epub 2019 Sep 11.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-471
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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