治験レーダー

Working Alliance Inventory (WAI) - Bond subscale

The WAI-Bond subscale scores 4 items, with scores ranging from 4-28. Higher scores are stronger perceived patient-therapist bond: how the participant experiences feelings of bond (i.e., feelings of mutual trust, acceptance, and connection) with their therapist.. The Bond subscale is a primary outcome measure for this study and the total score will be analyzed as a secondary outcome.

data collected at each CBT session (weeks 1-8)

Behavioral Activation for Depression Scale (BADS)

BADS is a 25-item survey, each item scored from 0 (not at all) to 6 (completely), with some items reverse scored. There are 4 sub-scales: Activation, Avoidance / Rumination, Work / School Impairment, Social Impairment. The total possible range of scores is from 0 to 150 where higher scores indicate higher behavioral activation (increased avoidance and impairment).

data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52

GRID Hamilton Rating Scale for Depression (GRID-HAMD)

The GRID-HAM-D is a 17-item clinician-completed questionnaire that will be used to rate depressive symptom severity. The questionnaire is designed for adults and is used to rate the intensity and frequency of depressive symptoms by probing mood, feelings of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. As recommended by the Depression Rating Scale Standardization Team, Clinical Interviewers will follow the Structured Interview Guide and use GRID scoring, in which dimensions of intensity and frequency of a symptom are rated independently for each item. Higher scores reflect greater symptom severity, categorized as Normal (0-7), Mild Depression (8-13), Moderate Depression (14-18), Severe Depression (19-22), and Very Severe Depression (greater than 23).

baseline, post intervention visit (week 9), week 20, week 52

Patient Health Questionnaire-9 (PHQ-9)

The PHQ-9 is a 9-item questionnaire that asks the participant to consider the last 2 weeks and score each question from 0-3 for a total possible range of scores from 0-27 where higher scores indicate increase depression.

data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52

Structured Clinical Interviews for DSM-5 Disorders (SCID)

The SCID is a semi-structured interview for making diagnoses according to the diagnostic criteria published in the American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders. Scoring on the SCID modules results in binary outcomes per each diagnostic module: either meeting criteria for a disorder or not meeting criteria for a disorder. As a secondary outcome measure, only the Major Depressive Disorder (MDD) modules of the SCID will be used. Rates of meeting MDD diagnostic criteria at baseline and post-therapy will be the primary time points used to compare remission rates between groups.

baseline, post intervention visit (week 9), week 20, week 52

Columbia Severity Suicide Rating (CSSRS)

The C-SSRS will be used to assess and monitor suicide ideation and behavior. The severity of the ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. Suicide behaviors are rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal, self-injurious behavior.

data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52

Dimensional Anhedonia Rating Scale (DARS)

The DARS is a self-report measure that assesses state anhedonia across multiple domains. DARS is a 17-item survey on state anhedonia divided into four domains: hobbies, food/drink, social activities, and sensory experiences. Participants must list two activities within each of these categories that they consider their favorite and then respond to questions regarding their interest in/enjoyment of those activities on a 5-point Likert scale from "Not at all" to "Very much." During pre/post-administration, participants will be asked to respond to how they are feeling "right now."

Weeks 1-8 CBT sessions (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final visit (week 9), 20-week follow up, 1-year follow up

Visual Analogue Scale (VAS)

An anhedonia Visual Analog Scale \[VAS\] with 0 indicating 'No pleasure at all' and 100 indicating 'Greatest pleasure imaginable' will be used to measure anhedonia. In past research by the PI, correlations between the DARS and VAS were 0.49-0.69 indicating a moderate-to-strong agreement between the measures. The VAS will be used to provide a supplementary assessment of anhedonia.

Weeks 1-8 CBT sessions (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final visit (week 9), 20-week follow up, 1-year follow up

Serum Brain Derived Neurotrophic Factor (BDNF)

Serum BDNF will be quantified from a standard blood draw. Blood samples collected during Visits 1, 4, and 8 will be allowed to clot for 30 minutes and then centrifuged for ten minutes at 5500 RPM and 4 ◦C. Following centrifugation, blood serum will be extracted with samples stored at -80 ◦C until BDNF analysis. Enzyme-linked immunosorbent assay (ELISA) kits will measure the concentration of total BDNF in the serum according to the manufacturer's instructions. Each blood sample will be run in duplicate and averaged.

Weeks 1, 4, and 8 CBT sessions (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)

Objective physical activity data (activPAL accelerometer) reported in minutes and number of steps per day

Participants will place an activPAL on the midline of the thigh on either leg and wear the monitor during all waking hours, removing it only for water-based activities (e.g., swimming). For data to be valid, the monitor must have been worn for 20 hours on at least 4 days, including a minimum of 3 weekdays and 1 weekend day. Sleep time will be parsed out from each day's sitting/lying time automatically using PALanalysis. From these data, average minutes of sitting per day will be used to assess total sedentary time, minutes of stepping time with a cadence greater than or equal to 75 and less than 100 will be used to assess minutes of light-intensity physical activity and minutes of stepping time with a cadence greater than or equal to 100 will be used to assess minutes of moderate to vigorous physical activity (MVPA). Sedentary time, physical activity time and sleep time will all be recorded in minutes per day. Steps are recorded as cumulative number of steps per day.

Baseline, weeks 4 & 8 CBT sessions (monitors worn 1 week following each time point)

Self-reported physical activity measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF) reported in minutes

The IPAQ is a physical activity questionnaire that inquires about average amounts of walking, moderate physical activity, vigorous physical activity, and sitting time per week. Walking and physical activity are reported in minutes per day of activity, sitting time is reported in hours per day.

baseline, week 4, post intervention visit (week 9), week 20, week 52

36-item Short Form health survey (SF-36)

The SF-36 assesses health-related quality of life. It consists of eight scaled scores (including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability (i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability).

baseline, week 4, post intervention visit (week 9), week 20, week 52

Generalized Anxiety Disorder 7 questionnaire (GAD-7)

Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for measuring generalized anxiety disorder. GAD-7 has seven items, which measure the severity of various signs of GAD according to reported response categories of: Not at all (0 points), Several days (1 point), More than half the days (2 points), and Nearly every day (3 points), with scores of 5, 10, and 15 as cut-off points for mild, moderate and severe anxiety, respectively.

baseline, week 4, post intervention visit (week 9), week 20, week 52

Automatic Thoughts Questionnaire

The ATQ is a 30-item instrument that measures the frequency of automatic negative statements about the self. Each item is rated on the frequency of an occurrence from "not at all" to "all the time". Total scores are the sum of all 30 items, with higher totals indicating a higher level of automatic negative self-statements.

baseline, weeks 1-8, post intervention visit (week 9), week 20, week 52

Session Evaluation Questionnaire (SEQ)

Session Evaluation Questionnaire (SEQ) will be used to evaluate session effectiveness. This includes responses to twenty-one items in a 7-point bipolar adjective format questionnaire to assess how the client feels about each CBT session. The questionnaire assesses session depth, smoothness, positivity, and arousal. An overall score of the average of the values across each subscale will be used in this study.

Weeks 1-8 CBT sessions

Average Lyssn-generated score

Lyssn is an AI-powered assessment platform for recording and managing session files, and all clinical interviews and therapy sessions will be recorded on the Lyssn platform. Lyssn will process the audio files from therapy sessions to generate session-level data. Lyssn generates metrics related to therapy effectiveness and fidelity, with individual metric scores (e.g., empathy, collaboration) ranging from 0 to 5 with higher scores indicated greater levels of the metric.

Weeks 1-8 CBT sessions

The Lam Employment Absence and Productivity Scale (LEAPS)

The LEAPS is a 10-item self-report scale that provides a measure of productivity in the workplace. Scores range from 0 to 28, with higher scores indicating higher impairment in work productivity.

baseline, post intervention visit (week 9), week 20, week 52

The Patient Global Impression of Change scale (PGIC)

The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time. Participants respond to the prompt "Since the start of the study, my overall status is: \[1\] 'Very Much Improved', \[2\] 'Much Improved', \[3\] 'Minimally Improved', \[4\] 'No Change', \[5\] 'Minimally Worse', \[6\] 'Much Worse', or \[7\] 'Very Much Worse'.

Weeks 9, 20, and 52

REST-Q

The REST-Q is a 9-item questionnaire assessing the extent to which the participants' last night of sleep was restful or restorative. Scores range from 0-36, with higher scores indicating more restful sleep.

baseline, post intervention visit (week 9), week 20, week 52

Emotion Regulation Questionnaire (ERQ)

The ERQ is a 10-item scale measuring emotional regulation on a 7-point scale for each question (total range: 7-70). Higher scores indicate increased use of emotion regulation strategies.

baseline, post intervention visit (week 9), week 20, week 52

Rumination Reflection Questionnaire (RRQ)

The RRQ is a 24-item questionnaire assessing levels of rumination. Each item is scored 1-5 (total scores ranging 24-120). Higher scores indicate higher levels of rumination.

baseline, post intervention visit (week 9), week 20, week 52

Working Alliance Inventory (WAI) - Total

The WAI scores 12 items from 1-7 in 3 domains: Tasks (4-28), Goals (4-28), Bond (4-28). Total possible range of scores from 12-84. In all domains higher scores are stronger perceived working alliance. The Bond subscale is a primary outcome measure. The total score and the two other subscales, Tasks and Goals, will be analyzed as secondary outcomes.

data collected at each CBT session (weeks 1-8)