Post Traumatic Stress Disorder PTSDPTSDNCT06669442
The Effectiveness of Guided Imagery on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder
A study testing Guided Imagery in people with Post Traumatic Stress Disorder PTSD, run by Nova Southeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD
- What is being tested?
- Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2025to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females
- PTSD diagnosis (ICD 10: F43.1)
- 18 to 99 years old
- Not pregnant
- No suicidal ideations
- No homicidal ideations
Show all 9Show fewer
- No audio-visual hallucinations
- A mobile device, smart phone, laptop
- Resident at the Residential Treatment Facility
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jessie Trice Community Health Systems
Miami, Florida, 33142
About this study
Official title: The Effectiveness of Guided Imagery, a Mindfulness Technique, on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder PTSD
- Being tested
- Guided Imagery
- Keywords
- Guided Imagery, Mindfulness, Post Traumatic Stress Disorder, Adult Women, Women, Stress Disorders, Post-Traumatic
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
Also called Guided Meditation, Visualization, Imagery, Mental Imagery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start19 Feb 2025
- Primary completion19 Feb 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress Disorder PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kellie-Ann Kerr, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669442
- Sponsor's protocol ID
- 2024-471
- Acronym
- PTSD
- Status last verified
- Apr 2025
- First submitted
- 30 Oct 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect the privacy and confidentiality of the participants. Sharing participant data may pose risks of identifying individuals in studies, with limited sample sizes or unique demographic profiles.
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.
PubMed 34435817Saban 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.
PubMed 36042095Roberts 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.
PubMed 34992744McNicholas 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.
PubMed 30886118Kozlov 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.
PubMed 33245289Krau 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.
PubMed 33131625Kachadourian 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.
PubMed 33475404Haider 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.
PubMed 33513582Gibson J. Trauma, early life stress, and mindfulness in adulthood. BMC Psychol. 2024 Feb 14;12(1):71. doi: 10.1186/s40359-024-01563-6.
PubMed 38355582Ehlers 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.
PubMed 24076408Beierl 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.
PubMed 31507261
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Guided Imagery, a Mindfulness Technique, on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06669442
- Acronym / sponsor ID
- PTSD / 2024-471
- Conditions
- Post Traumatic Stress Disorder PTSD
- Keywords
- Guided Imagery, Mindfulness, Post Traumatic Stress Disorder, Adult Women, Women, Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery Mindfulness | Experimental | Behavioral: Guided ImageryMindfulness-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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females
- PTSD diagnosis (ICD 10: F43.1)
- 18 to 99 years old
- Not pregnant
- No suicidal ideations
Key exclusion criteria (8 listed)
- Males
- Under 18 years old
- Above 99 years old
- Pregnant women
- Active suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryAlso: Guided Meditation, Visualization, Imagery, Mental ImageryGuided 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. | Behavioural | Guided Imagery Mindfulness |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 34435817Waldron 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.
- Background: PubMed 36042095Saban 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.
- Background: PubMed 34992744Roberts 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.
- Background: PubMed 30886118McNicholas 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.
- Background: PubMed 33245289Kozlov 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.
- Background: PubMed 33131625Krau 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.
- Background: PubMed 33475404Kachadourian 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.
- Background: PubMed 33513582Haider 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.
- Background: PubMed 38355582Gibson J. Trauma, early life stress, and mindfulness in adulthood. BMC Psychol. 2024 Feb 14;12(1):71. doi: 10.1186/s40359-024-01563-6.
- Background: PubMed 24076408Ehlers 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.
- Background: PubMed 31507261Beierl 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.
- Mindfulness Coach AppLink provided by the sponsor.
- PTSD Checklist for DSM-5 (PCL-5)Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared to protect the privacy and confidentiality of the participants. Sharing participant data may pose risks of identifying individuals in studies, with limited sample sizes or unique demographic profiles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Post Traumatic Stress Disorder PTSD, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline PTSD Symptom Severity Using PTSD Checklist for DSM-5 (PCL-5) Scores at 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06669442, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.