An Online CBT, Mindfulness Meditation & Yoga (CBT-MY) Intervention for Posttraumatic Stress Disorder

January 24, 2022 updated by: Paul Ritvo, York University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3J 1P3
        • York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Yoga Intervention
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.
Behavioral: Online Mindfulness-Based CBT & Trauma-Informed Yoga 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.
Other Names:
  • Online Trauma-Informed Mindfulness-Based CBT Intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 8-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability
Time Frame: Baseline and 8-weeks
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.
Baseline and 8-weeks
Change in Pupil Diameter
Time Frame: Baseline and 8-weeks
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.
Baseline and 8-weeks
Change in Respiration Rate
Time Frame: Baseline and 8-weeks
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.
Baseline and 8-weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - Civilian Version (PCL-5)
Time Frame: Baseline and 8-weeks
The PCL-5 is a standardised 20-item self-report scale for PTSD symptoms. Participants indicate how much they have been bothered by a symptom item listed over the past month using a five-point Likert scale ranging from 0 = Not at all to 4 = Extremely. The PCL-5 is easily scored by summing all of the items for a total symptom severity score ranging between 0 to 80. Clinically meaningful PTSD symptoms are present if items are rated as a minimum of 2 = "Moderately" or higher.
Baseline and 8-weeks
Change in Beck Anxiety Inventory (BAI)
Time Frame: Baseline and 8-weeks
The BAI is a 21-item self-report inventory to assess symptoms of anxiety within the last two weeks. Respondents rate how much each of the 21 symptoms bothered them in the past month on a four-point ordinal Likert scale from 0 = "not at all" to 3 = "severely, it bothered me a lot". Scoring for the BAI ranges from a minimum of 0 to a maximum of 63 based on summing the scores for all items. The following empirically supported cutoffs are followed for the interpretation of scores: 0-9 = normal/no anxiety, 10-18 = mild to moderate anxiety, 19-29 = moderate to severe anxiety, 30-63 = severe anxiety.
Baseline and 8-weeks
Change in Beck Depression Index-II (BDI-II)
Time Frame: Baseline and 8-weeks
Depression symptoms will be assessed using the BDI-II, a 21-item self-report survey. The BDI-II evaluates symptoms and attitudes related to depression using a four-level weighted Likert response scale ranging from 0 = not present to 3= severe. The participant is instructed to respond to items pertaining to how they were feeling in the past two weeks. Scoring for the BDI-II ranges from 0 to a maximum score of 63; empirically informed cutoff scores for severity of depression include the following: 0-13 = minimal, 14-19 = mild, 20-28 = moderate, 29-63 = severe.
Baseline and 8-weeks
Change in Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline and 8-weeks
Daily Mindfulness will be measured using the 39-item FFMQ. The FFMQ assesses changes in mindfulness tendencies (e.g., non-judgement of inner experience) before and after a mindfulness-based intervention. The FFMQ measures five mindfulness-based factors including non-reactivity, observing, describing, non-judgement, and acting with awareness. Item scores range on a five-level Likert scale of 1 = never or rarely true to 5 = very often or always true. The FFMQ is scored by summing all item responses and total scores range from 0 to 195, with higher scores indicating greater levels of mindfulness.
Baseline and 8-weeks
Change in Pain Catastrophizing Scale (PCS)
Time Frame: Baseline and 8-Weeks
Catastrophic thinking in relation to bodily pain will be measured using the 13-item self-report Pain Catastrophizing Scale. The PCS is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present. Previous studies have shown a cutoff of more than 30 points to be associated with clinical relevance. This measure has been found to have good psychometric properties, including high test-retest reliability and high internal consistency (Chronbach's alpha = 0.87-0.95). Some examples of the items include: "I keep thinking about how badly I want the pain to stop; I worry all the time about whether the pain will end; and I become afraid that the pain may get worse."
Baseline and 8-Weeks
24-Hour Recall of Pain using the Brief Pain Inventory - Short Form (BPI)
Time Frame: Baseline and 8-Weeks
The Brief Pain Inventory - Short Form is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on their daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The assessment produces a mean pain severity score and mean pain interference score. Higher scores indicate greater pain severity and interference.
Baseline and 8-Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
York University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paul Ritvo, PhD, York University, Toronto, Ontario, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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