Healthy
Conditions
Brief summary
The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin) leads to changes in emotion processing and neural circuitry that may predict repeated self-administration of this drug and underlie an atypical mechanism of abuse liability, which may vitally contribute to the understanding of the potential for abuse and the underlying mechanisms supporting abuse of classic hallucinogens.
Interventions
DRUGPsilocybin
25 mg/70 kg Psilocybin
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Have given written informed consent * Have at least a high-school level of education or equivalent, and be fluent in English * Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests * Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day. * Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. * Agree not to take any as needed medications on the mornings of drug sessions * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration. * Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals. * Have limited lifetime use of hallucinogens
Exclusion criteria
* Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control. * Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), artificial heart valve, or stroke in the past year * Epilepsy with history of seizures * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia * Currently taking psychoactive prescription medication on a regular (e.g., daily) basis * Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including mono-amine oxidase inhibitors (MAOIs). For individuals who have intermittent or as needed use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose. * More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table * Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder * Current or past history within the last 5 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) * Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder * Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin * Head trauma * Claustrophobia incompatible with scanning * Cardiac pacemaker * Implanted cardiac defibrillator * Aneurysm brain clip * Inner ear implant * Prior history as a metal worker and/or certain metallic objects in the body -- must complete magnetic resonance imaging (MRI) screening form and be approved by MRI technologist before each scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amygdala Response to Stimuli in the Emotion Recognition Test | 1 day pre (baseline), 1 week post, and 1 month post session | Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Longitudinal Emotion and Mood Questionnaire Scores | 1 day pre (baseline), 1 week post, and 1 month post session | Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood). Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales Positive & Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168) State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales Tellegen Absorption Scale (TAS): Range 0-34 Big Five Inventory (BFI): Range 1-5 on all subscales |
| Change in Emotional Functioning Task Accuracy | 1 day pre (baseline), 1 week post, and 1 month post session | These tasks measure emotional responding that may be altered by psilocybin. Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images. Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor. Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative. |
| Change in Emotional Functioning Tasks Response Time (Milliseconds) | 1-day pre (baseline), 1-week post, 1-month post session | These tasks measure emotional responding that may be altered by psilocybin. Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images. Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor. Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psilocybin Participants will be administered a 25 mg/70 kg dose of psilocybin
Psilocybin: 25 mg/70 kg Psilocybin | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Psilocybin |
|---|---|
| Age, Continuous | 32.2 years STANDARD_DEVIATION 7.2 |
| Education Level College | 4 Participants |
| Education Level High School/GED | 1 Participants |
| Education Level Post-Graduate | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 3 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Amygdala Response to Stimuli in the Emotion Recognition Test
Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.
Time frame: 1 day pre (baseline), 1 week post, and 1 month post session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Angry | 0.834 BOLD percent signal change | Standard Error 0.449 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Happy | 0.835 BOLD percent signal change | Standard Error 0.342 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Sad | 0.503 BOLD percent signal change | Standard Error 0.403 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Angry | 0.514 BOLD percent signal change | Standard Error 0.357 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Neutral | 1.081 BOLD percent signal change | Standard Error 0.428 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Neutral | 0.794 BOLD percent signal change | Standard Error 0.437 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Happy | 0.938 BOLD percent signal change | Standard Error 0.388 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Sad | 0.927 BOLD percent signal change | Standard Error 0.423 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Fearful | 0.979 BOLD percent signal change | Standard Error 0.424 |
| Baseline | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Fearful | 0.525 BOLD percent signal change | Standard Error 0.421 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Sad | -0.514 BOLD percent signal change | Standard Error 0.635 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Happy | -0.052 BOLD percent signal change | Standard Error 0.431 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Angry | -0.881 BOLD percent signal change | Standard Error 0.703 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Angry | -0.028 BOLD percent signal change | Standard Error 0.39 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Neutral | -0.256 BOLD percent signal change | Standard Error 0.358 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Fearful | -0.254 BOLD percent signal change | Standard Error 0.481 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Neutral | -0.825 BOLD percent signal change | Standard Error 0.572 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Fearful | -0.928 BOLD percent signal change | Standard Error 0.696 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Sad | 0.004 BOLD percent signal change | Standard Error 0.37 |
| 1-week Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Happy | -0.759 BOLD percent signal change | Standard Error 0.63 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Sad | 0.999 BOLD percent signal change | Standard Error 0.563 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Fearful | 0.664 BOLD percent signal change | Standard Error 0.584 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Happy | 0.619 BOLD percent signal change | Standard Error 0.449 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Fearful | 0.617 BOLD percent signal change | Standard Error 0.563 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Sad | 0.816 BOLD percent signal change | Standard Error 0.444 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Happy | 0.749 BOLD percent signal change | Standard Error 0.478 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Angry | 0.689 BOLD percent signal change | Standard Error 0.454 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | R Amygdala contrast: Neutral | 0.719 BOLD percent signal change | Standard Error 0.476 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Angry | 1.131 BOLD percent signal change | Standard Error 0.569 |
| 1-month Post Session | Amygdala Response to Stimuli in the Emotion Recognition Test | L Amygdala contrast: Neutral | 1.098 BOLD percent signal change | Standard Error 0.582 |
Secondary
Change in Emotional Functioning Task Accuracy
These tasks measure emotional responding that may be altered by psilocybin. Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images. Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor. Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.
Time frame: 1 day pre (baseline), 1 week post, and 1 month post session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Fearful | 100.0 percentage of correct responses | Standard Error 0 |
| Baseline | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Sad | 95.7 percentage of correct responses | Standard Error 2.1 |
| Baseline | Change in Emotional Functioning Task Accuracy | Emotional conflict Stroop: Incongruent | 98.1 percentage of correct responses | Standard Error 0.7 |
| Baseline | Change in Emotional Functioning Task Accuracy | Emotional conflict Stroop: Congruent | 99.5 percentage of correct responses | Standard Error 0.3 |
| Baseline | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Neutral | 93.8 percentage of correct responses | Standard Error 2.5 |
| Baseline | Change in Emotional Functioning Task Accuracy | Emotion discrimination: Faces | 87.1 percentage of correct responses | Standard Error 2.4 |
| Baseline | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Happy | 92.6 percentage of correct responses | Standard Error 2.7 |
| Baseline | Change in Emotional Functioning Task Accuracy | Emotion discrimination: Shapes (Control) | 97.0 percentage of correct responses | Standard Error 1 |
| Baseline | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Angry | 97.9 percentage of correct responses | Standard Error 1.5 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotion discrimination: Shapes (Control) | 97.0 percentage of correct responses | Standard Error 1 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotion discrimination: Faces | 92.3 percentage of correct responses | Standard Error 1.8 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotional conflict Stroop: Congruent | 99.8 percentage of correct responses | Standard Error 0.2 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Sad | 93.8 percentage of correct responses | Standard Error 2.5 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotional conflict Stroop: Incongruent | 97.9 percentage of correct responses | Standard Error 0.7 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Fearful | 99.0 percentage of correct responses | Standard Error 1 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Angry | 95.8 percentage of correct responses | Standard Error 2.1 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Neutral | 96.9 percentage of correct responses | Standard Error 1.8 |
| 1-week Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Happy | 95.8 percentage of correct responses | Standard Error 2.1 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotional conflict Stroop: Incongruent | 98.4 percentage of correct responses | Standard Error 0.6 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Fearful | 97.9 percentage of correct responses | Standard Error 1.5 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Sad | 94.8 percentage of correct responses | Standard Error 2.3 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Angry | 99.0 percentage of correct responses | Standard Error 1 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Neutral | 100.0 percentage of correct responses | Standard Error 0 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotion discrimination: Shapes (Control) | 95.0 percentage of correct responses | Standard Error 1.3 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotion discrimination: Faces | 93.2 percentage of correct responses | Standard Error 1.7 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotional conflict Stroop: Congruent | 99.5 percentage of correct responses | Standard Error 0.3 |
| 1-month Post Session | Change in Emotional Functioning Task Accuracy | Emotion recognition task: Happy | 97.9 percentage of correct responses | Standard Error 1.5 |
Secondary
Change in Emotional Functioning Tasks Response Time (Milliseconds)
These tasks measure emotional responding that may be altered by psilocybin. Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images. Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor. Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.
Time frame: 1-day pre (baseline), 1-week post, 1-month post session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Angry | 1380 milliseconds | Standard Error 45.9 |
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Sad | 1539 milliseconds | Standard Error 53 |
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion discrimination task: Shapes | 977.0 milliseconds | Standard Error 212.9 |
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Neutral | 1305 milliseconds | Standard Error 49.1 |
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Happy | 1670 milliseconds | Standard Error 59.5 |
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotional conflict Stroop: Congruent | 613.5 milliseconds | Standard Error 6.32 |
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Fearful | 1061 milliseconds | Standard Error 27.2 |
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotional conflict Stroop: Incongruent | 641.3 milliseconds | Standard Error 7.14 |
| Baseline | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion discrimination task: Faces | 1803 milliseconds | Standard Error 51.1 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Happy | 1383 milliseconds | Standard Error 41.2 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Sad | 1458 milliseconds | Standard Error 45.6 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Fearful | 1045 milliseconds | Standard Error 31.8 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Angry | 1193 milliseconds | Standard Error 36.4 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Neutral | 1594 milliseconds | Standard Error 49.2 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion discrimination task: Shapes | 1697 milliseconds | Standard Error 414.1 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion discrimination task: Faces | 1572 milliseconds | Standard Error 41.1 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotional conflict Stroop: Congruent | 606.3 milliseconds | Standard Error 5.88 |
| 1-week Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotional conflict Stroop: Incongruent | 631.4 milliseconds | Standard Error 7.03 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Fearful | 1130 milliseconds | Standard Error 40.8 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Happy | 1454 milliseconds | Standard Error 45.6 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion discrimination task: Faces | 1522 milliseconds | Standard Error 35.3 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Sad | 1596 milliseconds | Standard Error 56.8 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotional conflict Stroop: Incongruent | 614.1 milliseconds | Standard Error 6.71 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Neutral | 1017 milliseconds | Standard Error 33.4 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion recognition task: Angry | 1310 milliseconds | Standard Error 40.9 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotional conflict Stroop: Congruent | 603.2 milliseconds | Standard Error 7.18 |
| 1-month Post Session | Change in Emotional Functioning Tasks Response Time (Milliseconds) | Emotion discrimination task: Shapes | 1735 milliseconds | Standard Error 434.9 |
Secondary
Change in Longitudinal Emotion and Mood Questionnaire Scores
Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood). Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales Positive & Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168) State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales Tellegen Absorption Scale (TAS): Range 0-34 Big Five Inventory (BFI): Range 1-5 on all subscales
Time frame: 1 day pre (baseline), 1 week post, and 1 month post session
Population: The Big Five Inventory (BFI) and the Tellegen Absorption Scale (TAS) were not administered at 1-week post, and were only administered at Baseline and 1-month post.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Trait Anxiety (STAI) | 31.36 score on a scale | Standard Error 1.91 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Mood Disturbance (POMS) | 3.64 score on a scale | Standard Error 5.67 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Love (DPES) | 5.61 score on a scale | Standard Error 0.17 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Vigor (POMS) | 19.09 score on a scale | Standard Error 1.35 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Compassion (DPES) | 5.75 score on a scale | Standard Error 0.31 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Confusion (POMS) | 5.55 score on a scale | Standard Error 1.19 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Awe (DPES) | 5.52 score on a scale | Standard Error 0.26 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Openness (BFI) | 4.17 score on a scale | Standard Error 0.129 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Depression (POMS) | 3.36 score on a scale | Standard Error 0.81 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Positive Affect (PANAS-X) | 38.18 score on a scale | Standard Error 1.41 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Fatigue (POMS) | 4.09 score on a scale | Standard Error 1.37 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Tension (POMS) | 4.82 score on a scale | Standard Error 1.22 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Negative Affect (PANAS-X) | 16.09 score on a scale | Standard Error 1 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Absorption (TAS) | 0.98 score on a scale | Standard Error 0.176 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Stress (DASS) | 4.91 score on a scale | Standard Error 1.06 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Neuroticism (BFI) | 1.82 score on a scale | Standard Error 0.213 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Conscientiousness (BFI) | 3.82 score on a scale | Standard Error 0.172 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Joy (DPES) | 5.45 score on a scale | Standard Error 0.21 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Depression (DASS) | 1.82 score on a scale | Standard Error 0.57 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Agreeableness (BFI) | 4.43 score on a scale | Standard Error 0.099 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Content (DPES) | 5.62 score on a scale | Standard Error 0.24 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Anxiety (DASS) | 1.64 score on a scale | Standard Error 1.07 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Extraversion (BFI) | 3.46 score on a scale | Standard Error 0.19 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Pride (DPES) | 5.42 score on a scale | Standard Error 0.22 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | State Anxiety (STAI) | 28.0 score on a scale | Standard Error 2.41 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Amusement (DPES) | 5.02 score on a scale | Standard Error 0.31 |
| Baseline | Change in Longitudinal Emotion and Mood Questionnaire Scores | Anger (POMS) | 4.91 score on a scale | Standard Error 1.34 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Joy (DPES) | 6.02 score on a scale | Standard Error 0.17 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Depression (POMS) | 0.55 score on a scale | Standard Error 0.25 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Anger (POMS) | 2.18 score on a scale | Standard Error 0.58 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Depression (DASS) | 1.09 score on a scale | Standard Error 0.73 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Anxiety (DASS) | 1.64 score on a scale | Standard Error 0.75 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Compassion (DPES) | 6.25 score on a scale | Standard Error 0.26 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Stress (DASS) | 2.00 score on a scale | Standard Error 0.6 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Pride (DPES) | 5.96 score on a scale | Standard Error 0.14 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Content (DPES) | 6.27 score on a scale | Standard Error 0.16 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Amusement (DPES) | 5.60 score on a scale | Standard Error 0.32 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Love (DPES) | 5.92 score on a scale | Standard Error 0.25 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Awe (DPES) | 6.06 score on a scale | Standard Error 0.22 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Positive Affect (PANAS-X) | 40.64 score on a scale | Standard Error 1.28 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Negative Affect (PANAS-X) | 12.36 score on a scale | Standard Error 0.93 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Tension (POMS) | 1.73 score on a scale | Standard Error 0.49 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Confusion (POMS) | 4.27 score on a scale | Standard Error 0.79 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Vigor (POMS) | 21.45 score on a scale | Standard Error 1.77 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Mood Disturbance (POMS) | -10.5 score on a scale | Standard Error 3.23 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Fatigue (POMS) | 2.27 score on a scale | Standard Error 1.21 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | State Anxiety (STAI) | 22.82 score on a scale | Standard Error 1.37 |
| 1-week Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Trait Anxiety (STAI) | 28.55 score on a scale | Standard Error 1.32 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Conscientiousness (BFI) | 3.98 score on a scale | Standard Error 0.159 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Confusion (POMS) | 4.72 score on a scale | Standard Error 1.21 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Love (DPES) | 5.98 score on a scale | Standard Error 0.17 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Fatigue (POMS) | 2.72 score on a scale | Standard Error 1.06 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Vigor (POMS) | 22.09 score on a scale | Standard Error 2.15 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Pride (DPES) | 5.95 score on a scale | Standard Error 0.18 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Neuroticism (BFI) | 1.67 score on a scale | Standard Error 0.175 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Mood Disturbance (POMS) | -3.55 score on a scale | Standard Error 6.19 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Compassion (DPES) | 6.00 score on a scale | Standard Error 0.3 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Anger (POMS) | 4.64 score on a scale | Standard Error 0.98 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Content (DPES) | 6.13 score on a scale | Standard Error 0.23 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Joy (DPES) | 5.92 score on a scale | Standard Error 0.21 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Stress (DASS) | 3.27 score on a scale | Standard Error 1.12 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Anxiety (DASS) | 1.45 score on a scale | Standard Error 0.9 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Openness (BFI) | 4.22 score on a scale | Standard Error 0.151 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | State Anxiety (STAI) | 25.64 score on a scale | Standard Error 2.56 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Depression (DASS) | 1.64 score on a scale | Standard Error 0.59 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Absorption (TAS) | 1.31 score on a scale | Standard Error 0.233 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Trait Anxiety (STAI) | 25.64 score on a scale | Standard Error 27.55 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Extraversion (BFI) | 3.69 score on a scale | Standard Error 0.183 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Negative Affect (PANAS-X) | 16.09 score on a scale | Standard Error 0.8 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Positive Affect (PANAS-X) | 40.18 score on a scale | Standard Error 1.92 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Agreeableness (BFI) | 4.33 score on a scale | Standard Error 0.117 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Tension (POMS) | 3.82 score on a scale | Standard Error 1.19 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Awe (DPES) | 5.88 score on a scale | Standard Error 0.24 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Depression (POMS) | 2.64 score on a scale | Standard Error 1.03 |
| 1-month Post Session | Change in Longitudinal Emotion and Mood Questionnaire Scores | Amusement (DPES) | 5.71 score on a scale | Standard Error 0.31 |