Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change in Brief Resilience Scale (BRS) |
The BRS is a self-administered questionnaire with 6 items using a 5-point Likert-style scale to assess the ability to bounce back or recover from stress. Scores range from 6-30. Higher scores are indicative of greater resilience. Total score is determined by calculating the average across all 6 responses. Scores can then be classified as Low, Normal, or High Resilience. |
Baseline, Week 6, Week 12, Week 24 |
|
| Other |
Change in Positive and Negative Affect Schedule (PANAS) |
The PANAS is a 20-item subjective assessment of mood (10 items for Positive Affect [PA] and 10 for Negative Affect [NA]). Using a 5-point scale, participants rate the extent to which they have experienced each mood state during a specified time frame. Subscale scores for positive and negative affect are calculated with scores ranging from 10-50. For the Positive subscale, higher score equal more positive affect. For the negative affect subscale, higher scores are indicative of more negative affect. |
Baseline, Week 6, Week 12, Week 24 |
|
| Other |
Change in Patient Health Questionnaire-9 (PHQ-9) |
This self-report depression assessment uses a 3-point Likert scale (score range 0-27) with higher scores indicating greater depression severity. Participants rate the frequency of specified problems during the past 2 weeks. |
Baseline, Week 6, Week 12, Week 24 |
|
| Other |
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety |
The PROMIS Anxiety item bank (8a) is 8 items. The instrument measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). It uses a 5-point Likert scale, ranging from never to always. Anxiety scores range from 5-40 with higher scores indicating greater severity of anxiety. |
Baseline, Week 6, Week 12, Week 24 |
|
| Other |
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anger |
The PROMIS Anger item bank (5a) includes 5 items. The Anger instrument assesses self-reported angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. It uses a 5-point Likert scale, ranging from never to always. Anger scores range from 5-25 with higher scores indicating greater severity of anger. |
Baseline, Week 6, Week 12, Week 24 |
|
| Other |
Change in Post-traumatic Stress Checklist- 5 (PCL-5) |
The PCL-5 is a 20-item, self-rating scale that provides a quick and accurate measure of PTSD symptoms. Each item corresponds to current diagnostic criteria of PTSD, and each symptom is rated in terms of frequency and severity. Scores range from 0-80 with higher scores indicating greater symptom severity. |
Baseline, Week 6, Week 12, Week 24 |
|
| Other |
Patient Global Impression of Change (PGIC) |
The PGIC captures the patient perspective regarding the achievement of clinically important change with a single item asking perception of change across a Likert scale ranging from 1 (no change) to 7 (a great deal better and a considerable improvement). |
Week 12 and Week 24 |
|
| Other |
Post-treatment Satisfaction Survey |
Overall satisfaction and satisfaction with remote delivery will be evaluated with a 9-point scale. Participants will respond to the following statements: 1) Overall, how satisfied were you with BEST? (Overall treatment satisfaction); and 2) How satisfied were you with receiving this type of treatment remotely/ via teletherapy? (Teletherapy satisfaction). Scores on each scale range from 1-9. Lower scores indicate lower satisfaction. Higher scores indicate higher satisfaction. |
Week 12 |
|
| Other |
Change in Neurobehavioral Symptom Inventory (NSI) |
The NSI is a validated 22-item self-report measure that assesses the degree of disturbance in 3 neurobehavioral symptom domains in the past 2 weeks: somatic/ sensory (e.g. dizziness, balance, nausea, vision), affective (e.g., anxiety, depression, irritability, fatigue, sleep) and cognitive (e.g., concentration, forgetfulness, decision-making, slowed thinking). On this measure, respondents rate the degree of symptom severity on a five-point scale that ranges from zero (none; symptom is rarely ever present/not a problem at all) to four (very severe; symptom is almost always present/impairs performance at work, school, or home/individual probably cannot function without help). Scores range from 0 to 110, with higher scores indicative of more severe neurobehavioral symptoms. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Phenotypes and exposures (PhenX) Mental Health Core Items: Alcohol Use and Substance Use |
Participants will be asked their use, over the last 30 days, of alcohol (quantity and frequency) and substances (frequency). |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Alcohol Use Disorders Identification Test (AUDIT-C) |
The AUDIT-C is a 10-item validated self-report tool developed by the World Health Organization to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Scores range from 0-12 with higher scores indicating greater alcohol use and problems. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Drug Abuse Screen Test (DAST-10) |
This is a 10-item self-report questionnaire that provides an index of drug abuse problems. Scores range from 0-10 with higher scores indicating more drug abuse. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Pain Catastrophizing Scale |
This 13-item scale evaluates the thoughts and feelings people have related to their pain. Participants rate the degree to which they agree with statements describing thoughts/ feelings about their pain (e.g., I worry all the time about whether the pain will end) on a scale ranging from 0 (not at all) to 4 (all the time). The total scores range from 0-52, with higher scores indicating more severe pain catastrophizing. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in PROMIS Pain Intensity Short Form (3a) |
This is a 3 item self-assessment of worst pain and average pain intensity in the last 7 days as well as current pain. Scores range from 3-15 with higher scores indicating greater pain severity. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in PROMIS Pain Interference (8a short form) |
This is an eight item measure of self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Scores range from 6-30 with higher scores indicating more pain interference. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Perth Alexithymia Questionnaire (PAQ) |
This questionnaire asks about how participants perceive and experience unpleasant and pleasant emotions. Participants will be presented with statements and must indicate on a 7-point scale, how much they agree or disagree that the statement is true in describing themselves. Scores range from 24-168 with five subscale scores and a total score indicating level of alexithymia. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Ambivalence over Emotional Expressiveness Questionnaire (AEQ) |
This is a 14-item self-report of the degree to which one feels ambivalent about expressing emotions using a 5-point Likert scale, with higher scores indicating greater ambivalence in expression. Total scores range from 14-70. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Emotional Approach Coping (EAC) |
The 8-item emotional approach coping scale assesses participants' understanding and processing of emotions in general. The EAC has good internal consistency and validity. Items are rated from 1 (I usually don't do this at all) to 4 (I usually do this a lot) and averaged. Total scores range from 8- 32. Higher mean scores indicate more use of emotional approach as a coping style. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in UPPS-P (Negative Urgency subscale only) |
This measure evaluates various domains of impulsive behavior. One of these domain subscales is negative urgency, which is the only subscale that will be administered as part of this protocol. For this 4-item subscale, participants are presented with statements for which they must rate their agreement, using a 4-point Likert scale. Scores range from 4-16. Higher scores indicate more negative urgency. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Process Model of Emotion Regulation Questionnaire (PMERQ) |
This questionnaire evaluates engagement and disengagement strategies that people use to regulate their negative emotions at different stages of emotion regulation (situation selection, situation modification, attentional deployment, cognitive (re)appraisal, and response modulation). Participants rate the degree of their agreement with statements using a scale that ranges from -3 (Strongly Disagree) to 3 (Strongly Agree). |
Baseline, Week 12, Week 24 |
|
| Other |
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) |
The MAIA comprises 37 items on eight scales, conceptually organized in five dimensions: (a) Awareness of body sensations (Noticing scale), (b) emotional reaction and attentional response to sensations (Not-Distracting and Not-Worrying scales), (c) capacity to regulate attention (Attention Regulation scale), (d) awareness of mind-body integration (Emotional Awareness, Self-Regulation, and Body Listening scales), and (e) trusting body sensations (Trusting scale). Total scores range from 0-185. Higher score indicate greater interoceptive awareness. |
Baseline, Week 12, Week 24 |
|
| Other |
Change in NIH Toolbox Loneliness |
This 5 item measure of loneliness asks about the frequency with which participants felt different aspects of loneliness over the last month using a 5-point scale (1=Never to 5=Always). Total scores range from 5-25. Higher scores indicate more feelings of loneliness. |
Baseline, Week 12, Week 24 |
|
| Primary |
Change in Toronto Alexithymia Scale-20 (TAS-20) |
This is a 20-item self report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher (worse) alexithymia). Subscales are summed to compute a total score. |
Baseline, Week 6, Week 12, Week 24 |
|
| Secondary |
Change in Levels of Emotional Awareness Scale (LEAS) |
Objective, performance-based measure of emotional awareness and labeling. Short hypothetical scenarios are presented and participants are asked to describe how they and others would feel in the context of the scenarios. More discrete emotions earn more points (e.g., "sad" scores better than "bad"). Participants' responses are scored with an electronic system, removing human bias and interpretation. The LEAS has parallel forms (A and B), which will alternate at testing sessions. |
Baseline, Week 6, Week 12, Week 24 |
|
| Secondary |
Change in Difficulty with Emotion Regulation Scale (DERS) |
Using a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. There are 6 subscales: Lack of Emotional Awareness; Lack of Emotional Clarity; Difficulties Controlling Impulsive Behaviors when Distressed; Difficulties Engaging in Goal-Directed Behavior when Distressed; Non-acceptance of Negative Emotional Responses; and Limited Access to Effective Emotion Regulation Strategies. Items are summed to provide a Total Emotion Dysregulation score. Scores range from 5 (low) to 180 (high). Higher scores are indicative of more emotion dysregulation problems. The DERS has high internal consistency, test-retest reliability, and good construct validity. |
Baseline, Week 6, Week 12, Week 24 |
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