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

NCT06669442 | Completed

• 1 other identifier: 2024-471
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder PTSD

Keywords

Guided Imagery; Mindfulness; Post Traumatic Stress Disorder; Adult Women; Women; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Study Arms (1)

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.

Behavioral: Guided Imagery

Interventions

Guided Imagery BEHAVIORAL

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.

Also known as: Guided Meditation, Visualization, Imagery, Mental Imagery, Mental Rehearsal

Guided Imagery Mindfulness

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• PTSD diagnosis (ICD 10: F43.1)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Jessie Trice Community Health Systems

Miami, Florida, 33142, United States

Location

Related Publications (11)

• 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.

  PMID: 34435817 BACKGROUND

• 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.

  PMID: 36042095 BACKGROUND

• 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.

  PMID: 34992744 BACKGROUND

• 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.

  PMID: 30886118 BACKGROUND

• 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.

  PMID: 33245289 BACKGROUND

• 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.

  PMID: 33131625 BACKGROUND

• 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.

  PMID: 33475404 BACKGROUND

• 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.

  PMID: 33513582 BACKGROUND

• 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.

  PMID: 38355582 BACKGROUND

• 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.

  PMID: 24076408 BACKGROUND

• 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.

  PMID: 31507261 BACKGROUND

Related Links

• Mindfulness Coach App
• PTSD Checklist for DSM-5 (PCL-5)

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: February 19, 2025
• Primary Completion: February 19, 2025
• Study Completion: May 5, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)