Posttraumatic Stress DisordersNCT03684473
An Online CBT, Mindfulness Meditation & Yoga (CBT-MY) Intervention for Posttraumatic Stress Disorder
A study testing Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention in people with Posttraumatic Stress Disorders and PTSD, run by York University at 1 site in Canada.
Trial summary
Post-traumatic stress disorder (PTSD), a chronic, debilitating condition, is a growing public health concern as the Canadian population has the highest PTSD prevalence worldwide (9.2%; 3.7 million people). Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Posttraumatic Stress Disorders, PTSD
- What is being tested?
- Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2018to 31 Mar 2021
- 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 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Exposure to 1+ Lifetime Traumatic Events (LEC-5)
- Met clinical PTSD criteria and a minimum PTSD score of ≥ 12 on the Clinician Administered Posttraumatic Stress Scale (CAPS-5)
- 18-34 years of age
Who cannot join
- current/ongoing trauma (e.g., current physical or sexual abuse) within the last month
- current unstable medical condition
- current active suicide risk/self-harm and/or drug addiction
- current pregnancy/breastfeeding
- current yoga attendance within the last month
- no access to the internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Online CBT, Mindfulness Meditation, and Trauma-informed Yoga Intervention (CBT-MY) for Young Adults With Posttraumatic Stress Disorder: Evaluating Psychometric and Psychophysiology Outcomes
Post-traumatic stress disorder (PTSD), a chronic, debilitating condition, is a growing public health concern as the Canadian population has the highest PTSD prevalence worldwide (9.2%; 3.7 million people). PTSD is linked with other comorbid mental health disorders (e.g., depression) and increased risk of chronic disease (e.g., cardiovascular disease, obesity) which presents challenges as far as selection of the appropriate treatment approach. Adjunctive treatment approaches for PTSD that include somatic-sensory body awareness (e.g., mindfulness, yoga) have been shown to be viable treatment options to reduce stress-related symptoms and enhance emotion regulation. Online treatment delivery for mental health disorders demonstrate similar reductions in self-reported symptoms as face-to-face methods and emphasize accessibility, reduced costs, and enhanced appeal to certain demographic groups. A target population at risk of untreated PTSD symptoms that may benefit from an online treatment is young adults, 18-34 yrs., who have experienced childhood trauma. No known clinical trial (CT) has addressed the effectiveness of a brief (8-week) online trauma-informed yoga intervention using both self-report and objective psychophysiology measures. The purpose of this study is to evaluate changes in self-reported PTSD symptoms and objectively measured biomarkers of autonomic regulation via pupil dilation and heart-rate-variability (HRV) following an 8-week single-arm experimental design. It is hypothesized that clinically significant reductions of: 1) PTSD total symptom severity by 10% and 2) significant reductions in pupil dilation at post-intervention and; 3) significant increases in HRV at post-intervention. This is the first study to examine objective markers of autonomic regulation among an at-risk population using multiple novel technologies (e.g., Eye Tracking Glasses, HRV) and comparing two theoretically-linked measures (e.g., HRV, Pupillometry). Comparisons of psychophysiology data with a cross-sectional convenience sample with no history of clinical PTSD or mental health conditions were made.
Read the detailed description
Post-traumatic stress disorder (PTSD), a chronic, debilitating condition, is a growing public health concern as the Canadian population has the highest PTSD prevalence worldwide (9.2%; 3.7 million people). PTSD is linked with several co-morbid mental health disorders (e.g., depression) and increased risk of chronic disease (e.g., cardiovascular disease, obesity) which presents challenges as far as the determination of appropriate treatment. Adjunctive treatment approaches for PTSD that include somatic-sensory body awareness (e.g., mindfulness, yoga) have been shown to be viable treatment options to reduce stress-related symptoms and enhance emotion regulation. Online treatment deliveries for mental health disorders demonstrate similar reductions in self-reported symptoms as face-to-face methods and emphasize accessibility, reduced costs, and enhanced appeal to certain demographic groups. A target population at risk of untreated PTSD symptoms that may benefit from an online treatment is young adults, 18-34 yrs., who have experienced trauma during pre-adult development. No known clinical trial (CT) has addressed the effectiveness of a brief (8-week) online trauma-informed yoga intervention using both self-report and objective psychophysiology measures. This study evaluates such an intervention in terms of changes in self-reported PTSD symptoms and objectively measured biomarkers of autonomic regulation via pupil dilation and heart-rate-variability (HRV) following an 8-week single-arm experimental design. It is hypothesized that results will demonstrate clinically significant reductions of: 1) PTSD total symptom severity; 2) statistically significant reductions in pupil dilation and; 3) significant increases in HRV at post-intervention. This is the first study to examine objective markers of autonomic regulation in an at-risk population using multiple novel technologies (e.g., Eye Tracking Glasses, HRV) that compare two theoretically-linked measures (e.g., HRV, Pupillometry). Comparisons of psychophysiology data with a cross-sectional convenience sample with no history of clinical PTSD or mental health conditions are made
- Conditions
- Posttraumatic Stress Disorders, PTSD
- Being tested
- Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention
- Keywords
- Yoga, Mindfulness Meditation, Online, Posttraumatic Stress Disorder, Young Adulthood
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness-Based CBT & Trauma-Informed Yoga InterventionBehavioural
Also called Online Trauma-Informed Mindfulness-Based CBT Intervention
8 Weekly Online modules consisting of one weekly video of yoga postures combined with breath awareness and daily guided meditation audios, and a breath technique manual form the foundation of the intervention. The trauma-informed component of the program uses specific language, movement cues, teacher qualities, and physical assists. The yoga intervention will emphasize full choice and control of the participant through invitational language such as, "when you are ready", "if you like" before each body posture cue. Based on trauma-informed yoga best practices, a predictable foundation of yoga postures (with variations) will be followed in a consistent order each session to allow participants to anchor to the series.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Intervention | Experimental | Participants in the intervention condition will be assigned to an 8-week online delivered trauma-informed yoga protocol focused on home-based daily practice of yoga and mindfulness meditation. Receives: Behavioral: Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Posttraumatic Stress Symptoms on the Clinician Administered Posttraumatic Stress Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5)
A 30-item structured in-person interview with a trained clinician to confirm a current diagnosis of PTSD and associated symptoms based on a single index traumatic event (e.g., most recent, most severe). A single severity/distress score is calculated based on the frequency and intensity of a symptom using a 5-point scale (0 = absent/ no symptom; 1 = Mild/Symptom minimal; 2 = Moderate/Symptom Clearly Present; 3 = Severe/Symptom Pronounced; 4 = Extreme/Symptom is extreme/incapacitating). For a clinically significant symptom to be deemed present, a minimum frequency of twice per month or "some of the time" (approximately 20-30%) plus a minimum intensity of "clearly present" must be reported. Scores range from 0 to 80.
Measured: Baseline and 8-weeks
Secondary outcomes (3)
Change in Heart Rate Variability
Participants will undergo a 5-minute neutral stimulus, 5-minute emotional stimulus task, and 10-minute guided meditation protocol. Electrocardiogram (ECG) recordings will be collected using a 4-channel data acquisition system, which uses 2 adhesive electrodes applied to the chest and a ground electrode on the ankle. Frequency-based metrics represent respiratory-based modulation of the autonomic nervous system (ANS). The primary three spectral components for ECG recordings are very low frequency (VLF; 0.003-0.04 Hz), low frequency (LF; 0.04-0.15 Hz), and high frequency (HF; 0.15-0.4 Hz). Greater power in the HF band is considered to reflect respiratory sinus arrhythmia as it reflects HR variation attributed to parasympathetic (vagal) tone. Additionally, a ratio of LF to HF power will provide a marker of ANS regulation in all participants. A higher LF-HF ratio indicates "sympathetic dominance", whereas values closer to 0 reflect ANS balance.
Measured: Baseline and 8-weeks
Change in Pupil Diameter
Participants will wear specialised eye tracking glasses to obtain pupil dilation recordings. Accordingly, participants will be presented with a plain, neutral stimulus and asked to focus their eyes on a fixation cross on the computer. Baseline (BL) pupil diameter will be captured in the 500ms directly preceding the emotional stimulus. Participants will undergo an emotional stimulus (ES) task viewing standardized emotional images (e.g., happy, sad) on a computer screen followed by a guided 10-minute meditation (GM) phase. Average peak stimulus pupil dilation will be calculated during each phase (BL, ES, GM). Increased pupil dilation reflects sympathetic nervous system dominance.
Measured: Baseline and 8-weeks
Change in Respiration Rate
Participants will undergo a 5-minute neutral stimulus, 5-minute emotional stimulus task, and 10-minute guided meditation protocol. A respiratory belt transducer will be worn around the abdomen at the same time heart rate and pupil diameter are being measured. The respiratory belt transducer is measures changes in chest diameter resulting from breathing by producing a linear voltage proportional to changes in length and connects directly to a Pod (DIN) Port on the electrocardiogram machine. Breaths will be measured and recorded as the number of breaths per minute.
Measured: Baseline and 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start31 Oct 2018
- Primary completion15 Feb 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisordersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Ritvo, York University
- Investigators
- Paul Ritvo, PhD, Study director, York University, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684473
- Sponsor's protocol ID
- 2018-208
- Status last verified
- Jan 2022
- First submitted
- 9 Aug 2018
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirk MA, Taha B, Dang K, McCague H, Hatzinakos D, Katz J, Ritvo P. A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial. JMIR Ment Health. 2022 Feb 28;9(2):e26479. doi: 10.2196/26479.
PubMed 34499613
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online CBT, Mindfulness Meditation, and Trauma-informed Yoga Intervention (CBT-MY) for Young Adults With Posttraumatic Stress Disorder: Evaluating Psychometric and Psychophysiology Outcomes
- ClinicalTrials.gov ID
- NCT03684473
- Acronym / sponsor ID
- 2018-208
- Conditions
- Posttraumatic Stress Disorders, PTSD
- Keywords
- Yoga, Mindfulness Meditation, Online, Posttraumatic Stress Disorder, Young Adulthood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 25 Sep 2018 (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), a chronic, debilitating condition, is a growing public health concern as the Canadian population has the highest PTSD prevalence worldwide (9.2%; 3.7 million people). PTSD is linked with other comorbid mental health disorders (e.g., depression) and increased risk of chronic disease (e.g., cardiovascular disease, obesity) which presents challenges as far as selection of the appropriate treatment approach. Adjunctive treatment approaches for PTSD that include somatic-sensory body awareness (e.g., mindfulness, yoga) have been shown to be viable treatment options to reduce stress-related symptoms and enhance emotion regulation. Online treatment delivery for mental health disorders demonstrate similar reductions in self-reported symptoms as face-to-face methods and emphasize accessibility, reduced costs, and enhanced appeal to certain demographic groups. A target population at risk of untreated PTSD symptoms that may benefit from an online treatment is young adults, 18-34 yrs., who have experienced childhood trauma. No known clinical trial (CT) has addressed the effectiveness of a brief (8-week) online trauma-informed yoga intervention using both self-report and objective psychophysiology measures. The purpose of this study is to evaluate changes in self-reported PTSD symptoms and objectively measured biomarkers of autonomic regulation via pupil dilation and heart-rate-variability (HRV) following an 8-week single-arm experimental design. It is hypothesized that clinically significant reductions of: 1) PTSD total symptom severity by 10% and 2) significant reductions in pupil dilation at post-intervention and; 3) significant increases in HRV at post-intervention. This is the first study to examine objective markers of autonomic regulation among an at-risk population using multiple novel technologies (e.g., Eye Tracking Glasses, HRV) and comparing two theoretically-linked measures (e.g., HRV, Pupillometry). Comparisons of psychophysiology data with a cross-sectional convenience sample with no history of clinical PTSD or mental health conditions were made.
Detailed description
Post-traumatic stress disorder (PTSD), a chronic, debilitating condition, is a growing public health concern as the Canadian population has the highest PTSD prevalence worldwide (9.2%; 3.7 million people). PTSD is linked with several co-morbid mental health disorders (e.g., depression) and increased risk of chronic disease (e.g., cardiovascular disease, obesity) which presents challenges as far as the determination of appropriate treatment. Adjunctive treatment approaches for PTSD that include somatic-sensory body awareness (e.g., mindfulness, yoga) have been shown to be viable treatment options to reduce stress-related symptoms and enhance emotion regulation. Online treatment deliveries for mental health disorders demonstrate similar reductions in self-reported symptoms as face-to-face methods and emphasize accessibility, reduced costs, and enhanced appeal to certain demographic groups. A target population at risk of untreated PTSD symptoms that may benefit from an online treatment is young adults, 18-34 yrs., who have experienced trauma during pre-adult development. No known clinical trial (CT) has addressed the effectiveness of a brief (8-week) online trauma-informed yoga intervention using both self-report and objective psychophysiology measures. This study evaluates such an intervention in terms of changes in self-reported PTSD symptoms and objectively measured biomarkers of autonomic regulation via pupil dilation and heart-rate-variability (HRV) following an 8-week single-arm experimental design. It is hypothesized that results will demonstrate clinically significant reductions of: 1) PTSD total symptom severity; 2) statistically significant reductions in pupil dilation and; 3) significant increases in HRV at post-intervention. This is the first study to examine objective markers of autonomic regulation in an at-risk population using multiple novel technologies (e.g., Eye Tracking Glasses, HRV) that compare two theoretically-linked measures (e.g., HRV, Pupillometry). Comparisons of psychophysiology data with a cross-sectional convenience sample with no history of clinical PTSD or mental health conditions are made
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Behavioral: Online Mindfulness-Based CBT & Trauma-Informed Yoga InterventionParticipants in the intervention condition will be assigned to an 8-week online delivered trauma-informed yoga protocol focused on home-based daily practice of yoga and mindfulness meditation. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Exposure to 1+ Lifetime Traumatic Events (LEC-5)
- Met clinical PTSD criteria and a minimum PTSD score of ≥ 12 on the Clinician Administered Posttraumatic Stress Scale (CAPS-5)
- 18-34 years of age
Key exclusion criteria (6 listed)
- current/ongoing trauma (e.g., current physical or sexual abuse) within the last month
- current unstable medical condition
- current active suicide risk/self-harm and/or drug addiction
- current pregnancy/breastfeeding
- current yoga attendance within the last month
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 |
|---|---|---|
| Online Mindfulness-Based CBT & Trauma-Informed Yoga InterventionAlso: Online Trauma-Informed Mindfulness-Based CBT Intervention8 Weekly Online modules consisting of one weekly video of yoga postures combined with breath awareness and daily guided meditation audios, and a breath technique manual form the foundation of the intervention. The trauma-informed component of the program uses specific language, movement cues, teacher qualities, and physical assists. The yoga intervention will emphasize full choice and control of the participant through invitational language such as, "when you are ready", "if you like" before each body posture cue. Based on trauma-informed yoga best practices, a predictable foundation of yoga postures (with variations) will be followed in a consistent order each session to allow participants to anchor to the series. | Behavioural | Yoga Intervention |
Primary outcome
Change in Posttraumatic Stress Symptoms on the Clinician Administered Posttraumatic Stress Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5)
Time frame: Baseline and 8-weeks
A 30-item structured in-person interview with a trained clinician to confirm a current diagnosis of PTSD and associated symptoms based on a single index traumatic event (e.g., most recent, most severe). A single severity/distress score is calculated based on the frequency and intensity of a symptom using a 5-point scale (0 = absent/ no symptom; 1 = Mild/Symptom minimal; 2 = Moderate/Symptom Clearly Present; 3 = Severe/Symptom Pronounced; 4 = Extreme/Symptom is extreme/incapacitating). For a clinically significant symptom to be deemed present, a minimum frequency of twice per month or "some of the time" (approximately 20-30%) plus a minimum intensity of "clearly present" must be reported. Scores range from 0 to 80.
3 secondary outcomes
Change in Heart Rate Variability
Time frame: Baseline and 8-weeks
Change in Pupil Diameter
Time frame: Baseline and 8-weeks
Change in Respiration Rate
Time frame: Baseline and 8-weeks
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 8 Feb 2022.
- Derived from this study: PubMed 34499613Kirk MA, Taha B, Dang K, McCague H, Hatzinakos D, Katz J, Ritvo P. A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial. JMIR Ment Health. 2022 Feb 28;9(2):e26479. doi: 10.2196/26479.
- Individual participant dataSharing planned: No
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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.
Paul Ritvo, PhD study director
York University, Toronto, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention in people with Posttraumatic Stress Disorders and PTSD, run by York University at 1 site in Canada.
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 3 inclusion and 6 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 8 Feb 2022. 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 Canada. 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 in Posttraumatic Stress Symptoms on the Clinician Administered Posttraumatic Stress Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5) (time frame: Baseline and 8-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 NCT03684473, which also lists 1 linked publication.
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 8 Feb 2022.