Anxiety, Post Traumatic Stress Disorder
Conditions
Keywords
Post Traumatic Stress Disorder, Anxiety, PTSD treatment, Safe and Sound Protocol, SSP, auditory intervention, music intervention
Brief summary
The Safe and Sound Protocol (SSP) is a passive acoustic intervention that is designed as a neural exercise to promote efficient regulation of autonomic state. Prior research has shown that the SSP can improve autonomic function, auditory hypersensitivities, and emotion regulation in individuals with Autism Spectrum Disorders. This observational pilot study is being conducted to establish methods for an upcoming randomized controlled trial to test the utility of the SSP for trauma treatment. This study will enroll clients at the Spencer Psychology clinic who are set to take part in SSP under the supervision of their therapist. Because the therapists have participated in the design of the protocol and will participate in data collection and analysis, SSP will be considered a research procedure. In addition to taking part in SSP, subjects complete a set of questionnaires and have their pulse measured before starting the SSP intervention, after having completed 2/5 hours of the SSP, one week after completing all 5 hours of the SSP, and one month after completing the SSP intervention. The investigators will also pull relevant information from Spencer Psychology's medical records to document diagnosis, track client progress during study, and augment self-reported demographics. Clients who are receiving psychotherapy but not the SSP will be recruited as a comparison group.
Interventions
DEVICESafe and Sound Protocol
SSP is a non-invasive acoustic vagus nerve stimulator consisting of 5 hours of filtered and processed music designed to promote efficient regulation of autonomic state, and available through an app. The SSP is delivered via a mobile app and may fall under the heading of medical devices under the category of software functions/mobile medical applications.
BEHAVIORALPsychotherapy
All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively recieving psychotherapy. Participants will continue to recieve psychotherapy during the course of the study.
Sponsors
Spencer Psychology
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
SSP Intervention Arm: Inclusion Criteria: * Client at Spencer Psychology in Bloomington, Indiana * Diagnosed with PTSD or trauma not otherwise specified * Already have agreed with therapist to administer SSP as a part of therapy
Exclusion criteria
* Tinnitus or hearing loss * Diagnosed with cardiac arrhythmia * At high risk for 2019 novel coronavirus (COVID-19) complications based on Center for Disease Control (CDC) guidelines, unless vaccinated Comparison (Treatment As Usual) Arm Additional Criteria: Inclusion Criteria: 1. 18 years of age or older 2. Active psychotherapy client at Spencer Psychology 3. Diagnosis of PTSD or trauma not otherwise specified 4. Match range of PCL-5 baseline scores with treatment arm during screener survey
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Post Traumatic Stress Disorder Symptoms | 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm). | Change in PTSD symptoms from baseline, measured using the Post Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5), a 20-item self report. Total symptom severity scores range from 0 to 80, with higher scores indicating higher symptomology (poorer outcome). |
| Change From Baseline in Anxiety Symptoms | 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm). | Change from baseline in anxiety symptoms, measured using the Generalized Anxiety Disorder scale (GAD-7), 7-item self report. Scores range from 0-21 points, with higher scores indicating greater anxiety symptoms (poorer outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Self-reported Disruption of Autonomic Reactivity | 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm). | Change from baseline in autonomic symptoms, measured using the Body Perception Questionnaire (BPQ), 20-item self-report. T Scores (M = 50, SD = 10) were used, with higher scores indicating greater level of symptoms. |
| Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only] | 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm). | Change from baseline in mean heart period during supine, sitting, and standing posture shifts. Data was measured using an earlobe pulse sensor (Photoplethysmography). Longer heart period (higher values, reported in milliseconds) are indicative of lower autonomic arousal states. This metric is intended as a measure of mechanism and and high values may be associated with a better outcome. |
| Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only] | 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm). | Change from baseline in Respiratory sinus arrhythmia (RSA) - a component of heart rate variability - measured during supine, sitting, and standing posture shifts. Measurements were conducted using an earlobe pulse sensor (Photoplethysmography). Greater RSA (higher values, reported in ln\[milliseconds\]\^2) is associated with greater parasympathetic activity, which can help reduce physiological threat responses. This metric is intended to measure mechanism and high values may be associated with a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psychotherapy + SSP Safe and Sound Protocol: SSP is a non-invasive acoustic vagus nerve stimulator consisting of 5 hours of filtered and processed music designed to promote efficient regulation of autonomic state, and available through an app. The SSP is delivered via a mobile app and may fall under the heading of medical devices under the category of software functions/mobile medical applications.
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study. | 32 |
| Psychotherapy (Treatment as Usual) Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study. | 13 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Switched to different psychotherapy that was ineligible for study | 2 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 1 |
Baseline characteristics
| Characteristic | Psychotherapy (Treatment as Usual) | Total | Psychotherapy + SSP |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 8.72 | 35.6 years STANDARD_DEVIATION 12.4 | 35.3 years STANDARD_DEVIATION 13.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 41 Participants | 31 Participants |
| Sex: Female, Male Female | 12 Participants | 38 Participants | 26 Participants |
| Sex: Female, Male Male | 1 Participants | 7 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 13 |
| other Total, other adverse events | 1 / 32 | 0 / 13 |
| serious Total, serious adverse events | 0 / 32 | 0 / 13 |
Outcome results
Primary
Change From Baseline in Anxiety Symptoms
Change from baseline in anxiety symptoms, measured using the Generalized Anxiety Disorder scale (GAD-7), 7-item self report. Scores range from 0-21 points, with higher scores indicating greater anxiety symptoms (poorer outcome).
Time frame: 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).
Population: Intent to treat analysis with last observed value carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychotherapy + SSP | Change From Baseline in Anxiety Symptoms | -1.9 score on a scale | Standard Deviation 3.5 |
| Psychotherapy (Treatment as Usual) | Change From Baseline in Anxiety Symptoms | -0.8 score on a scale | Standard Deviation 3.4 |
Primary
Change From Baseline in Post Traumatic Stress Disorder Symptoms
Change in PTSD symptoms from baseline, measured using the Post Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5), a 20-item self report. Total symptom severity scores range from 0 to 80, with higher scores indicating higher symptomology (poorer outcome).
Time frame: 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).
Population: Results are change scores from intent-to-treat analysis in which the last observed value is carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychotherapy + SSP | Change From Baseline in Post Traumatic Stress Disorder Symptoms | -9.9 score on a scale | Standard Deviation 11.1 |
| Psychotherapy (Treatment as Usual) | Change From Baseline in Post Traumatic Stress Disorder Symptoms | -2.3 score on a scale | Standard Deviation 12.2 |
Secondary
Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only]
Change from baseline in mean heart period during supine, sitting, and standing posture shifts. Data was measured using an earlobe pulse sensor (Photoplethysmography). Longer heart period (higher values, reported in milliseconds) are indicative of lower autonomic arousal states. This metric is intended as a measure of mechanism and and high values may be associated with a better outcome.
Time frame: 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychotherapy + SSP | Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only] | Sitting | -90.0 milliseconds | Standard Deviation 134 |
| Psychotherapy + SSP | Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only] | Supine | -99.8 milliseconds | Standard Deviation 117 |
| Psychotherapy + SSP | Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only] | Standing | -70.2 milliseconds | — |
Secondary
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only]
Change from baseline in Respiratory sinus arrhythmia (RSA) - a component of heart rate variability - measured during supine, sitting, and standing posture shifts. Measurements were conducted using an earlobe pulse sensor (Photoplethysmography). Greater RSA (higher values, reported in ln\[milliseconds\]\^2) is associated with greater parasympathetic activity, which can help reduce physiological threat responses. This metric is intended to measure mechanism and high values may be associated with a better outcome.
Time frame: 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychotherapy + SSP | Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only] | Supine | -.35 ln[milliseconds]^2 | Standard Deviation 1 |
| Psychotherapy + SSP | Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only] | Sit | -.43 ln[milliseconds]^2 | Standard Deviation 1.44 |
| Psychotherapy + SSP | Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only] | Stand | -.04 ln[milliseconds]^2 | Standard Deviation 1.33 |
Secondary
Change From Baseline in Self-reported Disruption of Autonomic Reactivity
Change from baseline in autonomic symptoms, measured using the Body Perception Questionnaire (BPQ), 20-item self-report. T Scores (M = 50, SD = 10) were used, with higher scores indicating greater level of symptoms.
Time frame: 2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychotherapy + SSP | Change From Baseline in Self-reported Disruption of Autonomic Reactivity | -1.7 score on a scale | Standard Deviation 5.5 |
| Psychotherapy (Treatment as Usual) | Change From Baseline in Self-reported Disruption of Autonomic Reactivity | -0.1 score on a scale | Standard Deviation 5.2 |