An interventional study of ActiveCBT and CalmCBT in Major Depressive Disorder, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
This study investigates the effects of a novel intervention approach, intentionally sequencing aerobic exercise immediately prior to therapy sessions (i.e., cognitive behavioral therapy [CBT]) to determine its effects on both specific and common factors underlying the antidepressant effect of CBT (i.e., mechanisms of CBT). To assess the utility of this treatment augmentation, investigators plan to conduct a randomized controlled trial involving 40 adults with Major Depressive Disorder who will watch a nature documentary while either resting quietly (termed 'CalmCBT') or exercising at a moderate intensity ('ActiveCBT') immediately prior to 8 weekly sessions of CBT. It is hypothesized that target CBT mechanisms of antidepressant action (i.e., self-reported working alliance and behavioral activation) will be more effectively engaged by ActiveCBT vs. CalmCBT.
Frontline treatments for major depressive disorder (MDD), including cognitive behavioral therapy (CBT), have limited effectiveness, with half of patients not responding to CBT and half relapsing within 2 years. Strategies that increase the potency of MDD treatments are needed. We are testing a novel treatment strategy using aerobic exercise to prime a subsequent CBT session ('ActiveCBT'). Exercise priming is hypothesized to lead to greater engagement of CBT mechanisms of action through both common and specific factors linked to depression outcomes; this CBT augmentation approach has yet to be empirically tested. The study will consist of an 8-week randomized controlled trial in 40 adults with MDD performing 30-minutes of moderate exercise or quiet rest (CalmCBT vs. ActiveCBT) prior to weekly CBT sessions. Using a time- and attention-matched control, all participants will view a standardized documentary series for these 30 pre-therapy minutes with the only difference between groups being exercise or calmly resting. This project will also employ machine learning and natural language processing via the Lyssn platform to objectively evaluate the language and words used during therapy. The overall goals are to: 1) demonstrate exercise priming effects on target CBT mechanisms, 2) link psychological and neuroplastic exercise priming to CBT mechanisms, and 3) explore the sensitivity of objective machine learning-based markers from Lyssn to ActiveCBT-induced therapy differences. This trial will establish the potential for a subsequent confirmatory efficacy trial to rigorously test the potential of exercise priming to enhance treatment. If this innovative, biologically-informed approach successfully 'primes' subsequent therapy, this could be used to augment other treatments and in other disorders, significantly improving mental health treatment.
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This study's enrollment of 40 is below the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
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Exclusion Criteria:
Participants will complete a standardized 30-minute exercise session on a stationary bike prior to therapy. Participants will view one of 8 standardized 30-minute nature documentary videos while exercising.
Behavioral: ActiveCBT
Participants will view one of 8 standardized 30-minute nature documentary videos while resting quietly prior to therapy.
Behavioral: CalmCBT
Participants will complete a standardized 30-minute aerobic exercise session on a stationary bicycle prior to therapy. Supervised exercise sessions will consist of steady-state exercise at a moderate intensity corresponding to a '13' or 'somewhat hard' rating of perceived exertion. Continuous monitoring of heart rate, resistance/load, and RPE will occur throughout exercise. To closely match the groups, participants will also view 30-minute nature videos while exercising.
Participants will view one of 8 standardized 30-minute nature videos while resting quietly prior to therapy. These are emotionally neutral videos and will allow for participants in both groups to have the same amount of attention and contact time.
Average Self-reported Working Alliance Measured by Working Alliance Inventory (WAI)
Working Alliance Inventory-Short Revised (WAI) is a 12-item survey on experiences over a therapy session and connection with a therapist. It consists of three subscales: tasks, goals, and therapist-client bond. The total range of scores is from 12-84 with higher scores indicating a better therapeutic alliance.
Time frame: Weeks 1-8 CBT+ visits
Self-reported Behavioral Activation Measured by Behavioral Activation for Depression Scale (BADS)
The Behavioral Activation for Depression Scale (BADS) will be used to assess changes in behavioral activity. The scale is designed to be administered weekly to measure changes over the course of Behavioral Activation for depression. It consists of 25 questions that inquire about Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment. Each item is rated on a 7-point scale from 0 (Not at all) to 6 (Completely) with total scores ranging: 0-150 where higher scores indicate greater behavioral activation.
Time frame: Intake, Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
Change in Clinician-rated Depression Symptoms Measured by GRID-Hamilton Depression Rating Scale (GRID-HAM-D) From Intake
The GRID-HAM-D is a 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. Total scores are calculated from each question and range from 0 to 52, with higher scores indicated greater depressive symptom severity.
Time frame: Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Change in Self-reported Depression Symptoms Measured by Patient Health Questionnaire-9 (PHQ-9) From Week 1
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report instrument used to assess presence and severity of depressive symptoms, with scores categorized 0-4, 5-9, 10-14, 15-19, and 20-27 as minimal, mild, moderate, moderately severe, and severe depression, respectively.
Time frame: Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
MDD Diagnosis Measured by Structured Clinical Interview for DSM-5 Disorders (SCID)
The SCID is a clinician-administered semi-structured interview guide for making diagnoses according to the diagnostic criteria published in the American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders (DSM-5). It provides diagnoses for inclusion and exclusionary diagnoses. Results show number of participants who meet criteria for Major Depressive Disorder (i.e., 'checked') or no longer meet criteria (i.e., 'unchecked').
Time frame: Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Average Anhedonia Measured by 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. Subjects 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" (0) to "Very much" (4), with total scores ranging from 0 to 68, with higher scores representing reduced anhedonia.
Time frame: Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy])
Average Anhedonia Measured by an Anhedonia Visual Analogue Scale (Anhedonia 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. The VAS will be used to provide a supplementary assessment of anhedonia.
Time frame: Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy])
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.
Time frame: Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
Change in Anxiety Measured by Generalized Anxiety Disorder 7 (GAD-7) From Intake
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). A total score is calculated ranging from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Average Automatic Thoughts Measured by Automatic Thoughts Questionnaire (ATQ)
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 (ranging 30-150), with higher totals indicating a higher level of automatic negative self-statements.
Time frame: Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
Average Session Effectiveness Measured by 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 subscales will be used in this study (ranging 7-28). Higher scores indicate more favorable session evaluations.
Time frame: Weeks 1-8 CBT+ visits
Average Lyssn Generated Scores
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 regarding collaboration and empathy as metrics related to the primary client ratings of working alliance, as well as generating CTRS fidelity metrics which will be used in the ongoing supervision and fidelity monitoring of all sessions.
Time frame: Weeks 1-8 CBT+ visits
Nature Connectedness Index (NCI)
The NCI consist of 6 questions pertaining to nature connectedness. Participants respond using a 7-point Likert scale, ranging from 1 (Strongly Disagree) to 7 (Strongly Agree), with higher scores indicating greater levels of nature connectedness.
Time frame: Intake, Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
Change in Monitor-assessed Physical Activity Measured by Accelerometry
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 ≥75 and \<100 will be used to assess minutes of light-intensity physical activity and minutes of stepping time with a cadence ≥100 will be used to assess minutes of moderate to vigorous physical activity (MVPA).
Time frame: Intake, weeks 4 & 8 CBT+ visits (monitors worn 1 week following each time point)
Change in Quality of Life Measured by the 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).
Time frame: Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Change in Self-reported Physical Activity Measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF)
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.
Time frame: Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Change in Suicidal Thoughts Measured by the Columbia-Suicide Severity Rating Scale (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.
Time frame: Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
Health History Questions
Health history will be self-reported. In addition, participants will be asked to list their current medications.
Time frame: Intake
Demographic Questionnaire
Demographic characteristics including age, sex, race, education, marital status, occupational status, and household income will be recorded or measured to characterize the sample.
Time frame: Intake
Adverse Childhood Experience Survey (ACES)
The ACES consists of 16 questions pertaining to the respondents' first 18 years of life. Participants respond with yes or no regarding if a childhood adverse event occurred. Adverse events questions are grouped by categories. Participants are scored for each event category they are exposed to with scores ranging from 0 (unexposed) to 7 (exposed to all categories).
Time frame: Intake
| Milestone | ActiveCBT | CalmCBT |
|---|---|---|
| Started | 19 | 21 |
| Analysis population | 19 | 21 |
| Completed | 16 | 18 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 3 | 3 |
Working Alliance Inventory-Short Revised (WAI) is a 12-item survey on experiences over a therapy session and connection with a therapist. It consists of three subscales: tasks, goals, and therapist-client bond. The total range of scores is from 12-84 with higher scores indicating a better therapeutic alliance.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| Week 1 | 42.2 ± 6.43 | 42.8 ± 8.89 |
| Week 2 | 47.8 ± 5.99 | 45.8 ± 9.02 |
| Week 3 | 49.9 ± 6.05 | 48.1 ± 9.24 |
| Week 4 | 51.1 ± 6.27 | 49.6 ± 10.4 |
| Week 5 | 53.2 ± 4.92 | 51.2 ± 7.63 |
| Week 6 | 52.0 ± 7.79 | 51.7 ± 7.60 |
| Week 7 | 53.7 ± 6.69 | 53.6 ± 7.16 |
| Week 8 | 55.7 ± 4.33 | 55.0 ± 5.26 |
The Behavioral Activation for Depression Scale (BADS) will be used to assess changes in behavioral activity. The scale is designed to be administered weekly to measure changes over the course of Behavioral Activation for depression. It consists of 25 questions that inquire about Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment. Each item is rated on a 7-point scale from 0 (Not at all) to 6 (Completely) with total scores ranging: 0-150 where higher scores indicate greater behavioral activation.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| Intake | 72.7 ± 17.2 | 69.1 ± 24.2 |
| Weeks 1 | 72.7 ± 19.3 | 70.3 ± 22.9 |
| Week 2 | 79.1 ± 19.2 | 69.6 ± 22.7 |
| Week 3 | 84.4 ± 22.3 | 81.1 ± 21.1 |
| Week 4 | 87.1 ± 18.9 | 77.9 ± 17.8 |
| Week 5 | 88.4 ± 25.2 | 85.4 ± 13.1 |
| Week 6 | 94.0 ± 21.4 | 82.9 ± 13.1 |
| Week 7 | 95.8 ± 23.4 | 92.1 ± 22.3 |
| Week 8 | 101 ± 23.9 | 93.3 ± 25.3 |
| Week 9 (Post-therapy) | 106 ± 20.7 | 98.2 ± 25.3 |
| 12 week follow up | 103 ± 20.6 | 101 ± 22.2 |
| 1 year follow up | 108 ± 21.3 | 96.4 ± 22.4 |
The GRID-HAM-D is a 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. Total scores are calculated from each question and range from 0 to 52, with higher scores indicated greater depressive symptom severity.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| Intake to Week 9 (Post-therapy) | -7.38 ± 6.99 | -6.72 ± 4.87 |
| Intake to 12 week follow up | -8.00 ± 7.30 | -7.06 ± 4.90 |
| Intake to 1 year follow up | -9.18 ± 7.24 | -8.44 ± 6.10 |
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report instrument used to assess presence and severity of depressive symptoms, with scores categorized 0-4, 5-9, 10-14, 15-19, and 20-27 as minimal, mild, moderate, moderately severe, and severe depression, respectively.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| Week 1 to Week 2 | -0.500 ± 3.07 | -1.20 ± 2.78 |
| Week 1 to Week 3 | -2.24 ± 3.19 | -3.21 ± 5.40 |
| Week 1 to Week 4 | -1.94 ± 3.91 | -2.33 ± 4.37 |
| Week 1 to Week 5 | -2.63 ± 4.26 | -3.89 ± 4.61 |
| Week 1 to Week 6 | -3.27 ± 4.10 | -4.50 ± 4.41 |
| Week 1 to Week 7 | -3.13 ± 4.70 | -5.50 ± 5.66 |
| Week 1 to Week 8 | -4.80 ± 3.78 | -6.44 ± 5.93 |
| Week 1 to Week 9 (Post-Therapy) | -5.13 ± 4.42 | -6.39 ± 6.64 |
| Week 1 to 12 week follow up | -6.14 ± 4.55 | -7.72 ± 5.64 |
| Week 1 to 1 year follow up | -6.73 ± 5.46 | -6.88 ± 6.15 |
The SCID is a clinician-administered semi-structured interview guide for making diagnoses according to the diagnostic criteria published in the American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders (DSM-5). It provides diagnoses for inclusion and exclusionary diagnoses. Results show number of participants who meet criteria for Major Depressive Disorder (i.e., 'checked') or no longer meet criteria (i.e., 'unchecked').
| Participants | ActiveCBT | CalmCBT |
|---|---|---|
| Intake — Checked | 19 | 21 |
| Intake — Unchecked | 0 | 0 |
| Week 9 (Post-therapy) — Checked | 2 | 2 |
| Week 9 (Post-therapy) — Unchecked | 14 | 16 |
| 12 week follow up — Checked | 1 | 1 |
| 12 week follow up — Unchecked | 13 | 17 |
| 1 year follow up — Checked | 1 | 3 |
| 1 year follow up — Unchecked | 10 | 13 |
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. Subjects 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" (0) to "Very much" (4), with total scores ranging from 0 to 68, with higher scores representing reduced anhedonia.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| pre Week 1 | 39.4 ± 12.2 | 34.8 ± 15.4 |
| mid Week 1 | 42.3 ± 11.6 | 36.0 ± 16.8 |
| post Week 1 | 40.1 ± 15.2 | 39.9 ± 17.3 |
| pre Week 2 | 39.1 ± 11.8 | 37.1 ± 13.5 |
| mid Week 2 | 43.3 ± 10.4 | 36.1 ± 15.4 |
| post Week 2 | 45.6 ± 10.4 | 42.6 ± 13.4 |
| pre Week 3 | 37.9 ± 12.1 | 34.9 ± 15.0 |
| mid Week 3 | 41.4 ± 11.2 | 38.9 ± 17.0 |
| post Week 3 | 44.4 ± 8.30 | 42.2 ± 18.7 |
| pre Week 4 | 39.3 ± 13.7 | 36.1 ± 17.7 |
| mid Week 4 | 44.8 ± 12.5 | 39.8 ± 18.1 |
| post Week 4 | 47.2 ± 13.6 | 44.2 ± 18.5 |
| pre Week 5 | 38.1 ± 13.9 | 39.2 ± 16.6 |
| mid Week 5 | 41.3 ± 15.2 | 39.9 ± 20.7 |
| post Week 5 | 47.6 ± 13.3 | 46.5 ± 17.3 |
| pre Week 6 | 37.7 ± 12.1 | 33.7 ± 16.3 |
| mid Week 6 | 41.7 ± 14.5 | 37.1 ± 16.5 |
| post Week 6 | 44.5 ± 12.7 | 42.0 ± 18.0 |
| pre Week 7 | 34.7 ± 14.8 | 43.1 ± 17.8 |
| mid Week 7 | 38.6 ± 14.9 | 41.9 ± 18.5 |
| post Week 7 | 44.3 ± 9.45 | 44.4 ± 18.3 |
| pre Week 8 | 42.1 ± 9.45 | 40.2 ± 19.7 |
| mid Week 8 | 47.6 ± 10.3 | 42.6 ± 19.0 |
| post Week 8 | 51.3 ± 11.0 | 46.1 ± 18.4 |
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. The VAS will be used to provide a supplementary assessment of anhedonia.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| pre Week 1 | 38.2 ± 17.9 | 38.8 ± 20.7 |
| mid Week 1 | 54.5 ± 13.4 | 46.0 ± 16.1 |
| post Week 1 | 57.8 ± 13.2 | 57.3 ± 18.0 |
| pre Week 2 | 44.7 ± 17.0 | 42.9 ± 15.3 |
| mid Week 2 | 53.9 ± 12.8 | 47.2 ± 11.8 |
| post Week 2 | 56.1 ± 14.7 | 61.5 ± 13.2 |
| pre Week 3 | 46.0 ± 13.3 | 44.9 ± 16.0 |
| mid Week 3 | 53.6 ± 8.96 | 53.3 ± 11.4 |
| post Week 3 | 63.0 ± 9.24 | 59.4 ± 13.6 |
| pre Week 4 | 46.8 ± 13.8 | 42.1 ± 14.3 |
| mid Week 4 | 56.2 ± 8.66 | 53.7 ± 10.0 |
| post Week 4 | 64.3 ± 11.6 | 65.3 ± 17.0 |
| pre Week 5 | 42.4 ± 16.7 | 48.4 ± 13.8 |
| mid Week 5 | 56.9 ± 7.96 | 54.2 ± 10.5 |
| post Week 5 | 66.1 ± 9.84 | 66.5 ± 14.8 |
| pre Week 6 | 48.5 ± 9.13 | 41.3 ± 14.8 |
| mid Week 6 | 56.8 ± 7.59 | 45.5 ± 15.8 |
| post Week 6 | 65.7 ± 13.1 | 60.6 ± 15.4 |
| pre Week 7 | 48.0 ± 17.0 | 54.6 ± 15.8 |
| mid Week 7 | 54.2 ± 12.0 | 61.0 ± 12.8 |
| post Week 7 | 65.6 ± 11.9 | 65.2 ± 22.2 |
| pre Week 8 | 56.1 ± 9.78 | 54.1 ± 15.5 |
| mid Week 8 | 62.1 ± 9.77 | 59.2 ± 8.93 |
| post Week 8 | 70.7 ± 12.3 | 68.9 ± 15.5 |
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.
| ng/mL | ActiveCBT | CalmCBT |
|---|---|---|
| pre Week 1 | 230 ± 68.4 | 220 ± 76.6 |
| mid Week 1 | 315 ± 114 | 228 ± 90.9 |
| post Week 1 | 262 ± 95.2 | 240 ± 107 |
| pre Week 4 | 307 ± 131 | 237 ± 101 |
| mid Week 4 | 293 ± 168 | 202 ± 91.1 |
| post Week 4 | 293 ± 133 | 205 ± 61.7 |
| pre Week 8 | 255 ± 83.9 | 196 ± 80.7 |
| mid Week 8 | 256 ± 77.7 | 199 ± 86.1 |
| post Week 8 | 240 ± 89.8 | 226 ± 107 |
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). A total score is calculated ranging from 0 to 21, with higher scores indicating more severe anxiety symptoms.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| Intake to Week 4 | -1.00 ± 3.69 | -0.389 ± 3.09 |
| Intake to Week 9 (Post-Therapy) | -4.50 ± 5.37 | -3.94 ± 5.10 |
| Intake to 12 week follow up | -4.57 ± 5.30 | -4.89 ± 5.23 |
| Intake to 1 year follow up | -4.91 ± 4.74 | -3.47 ± 6.64 |
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 (ranging 30-150), with higher totals indicating a higher level of automatic negative self-statements.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| Intake | 85.6 ± 26.5 | 95.8 ± 23.4 |
| Week 1 | 82.3 ± 26.5 | 91.0 ± 27.3 |
| Week 2 | 76.5 ± 26.9 | 91.0 ± 22.1 |
| Week 3 | 77.6 ± 29.4 | 82.9 ± 24.6 |
| Week 4 | 74.1 ± 25.2 | 83.1 ± 22.8 |
| Week 5 | 67.3 ± 26.1 | 75.8 ± 24.1 |
| Week 6 | 63.9 ± 25.1 | 76.3 ± 28.5 |
| Week 7 | 63.0 ± 25.1 | 67.5 ± 26.5 |
| Week 8 | 55.7 ± 21.7 | 67.1 ± 27.2 |
| Week 9 (Post Therapy) | 50.9 ± 20.2 | 63.6 ± 27.6 |
| 12 week follow up | 51.1 ± 20.1 | 55.1 ± 21.9 |
| 1 year follow up | 57.5 ± 28.2 | 54.2 ± 19.8 |
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 subscales will be used in this study (ranging 7-28). Higher scores indicate more favorable session evaluations.
| score on a scale | ActiveCBT | CalmCBT |
|---|---|---|
| Week 1 | 18.1 ± 1.76 | 17.7 ± 2.86 |
| Week 2 | 18.7 ± 2.63 | 19.0 ± 3.15 |
| Week 3 | 19.1 ± 2.21 | 19.0 ± 3.63 |
| Week 4 | 19.5 ± 2.90 | 19.7 ± 3.28 |
| Week 5 | 20.3 ± 2.27 | 19.5 ± 3.68 |
| Week 6 | 20.2 ± 3.31 | 19.4 ± 3.24 |
| Week 7 | 19.6 ± 2.94 | 19.9 ± 4.02 |
| Week 8 | 21.6 ± 2.13 | 21.0 ± 3.17 |
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 regarding collaboration and empathy as metrics related to the primary client ratings of working alliance, as well as generating CTRS fidelity metrics which will be used in the ongoing supervision and fidelity monitoring of all sessions.
Results for this outcome have not been posted.
The NCI consist of 6 questions pertaining to nature connectedness. Participants respond using a 7-point Likert scale, ranging from 1 (Strongly Disagree) to 7 (Strongly Agree), with higher scores indicating greater levels of nature connectedness.
Results for this outcome have not been posted.
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 ≥75 and \<100 will be used to assess minutes of light-intensity physical activity and minutes of stepping time with a cadence ≥100 will be used to assess minutes of moderate to vigorous physical activity (MVPA).
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Health history will be self-reported. In addition, participants will be asked to list their current medications.
Results for this outcome have not been posted.
Demographic characteristics including age, sex, race, education, marital status, occupational status, and household income will be recorded or measured to characterize the sample.
Results for this outcome have not been posted.
The ACES consists of 16 questions pertaining to the respondents' first 18 years of life. Participants respond with yes or no regarding if a childhood adverse event occurred. Adverse events questions are grouped by categories. Participants are scored for each event category they are exposed to with scores ranging from 0 (unexposed) to 7 (exposed to all categories).
Results for this outcome have not been posted.
Collected over up to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ActiveCBT | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| CalmCBT | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | ActiveCBT | CalmCBT | Total |
|---|---|---|---|
| Mean | 30.2 ± 12.8 | 29.9 ± 13.3 | 30.1 ± 12.9 |
| Sex/Gender, Customized(Participants) | ActiveCBT | CalmCBT | Total |
|---|---|---|---|
| Male | 6 | 8 | 14 |
| Female | 13 | 12 | 25 |
| Gender nonconforming | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | ActiveCBT | CalmCBT | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 17 | 16 | 33 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | ActiveCBT | CalmCBT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 17 | 16 | 33 |
| More than one race | 1 | 5 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | ActiveCBT | CalmCBT | Total |
|---|---|---|---|
| United States | 19 | 21 | 40 |
| Education(Participants) | ActiveCBT | CalmCBT | Total |
|---|---|---|---|
| High School Graduate | 1 | 1 | 2 |
| Some College | 8 | 11 | 19 |
| College Graduate | 3 | 5 | 8 |
| Some Postgraduate School | 3 | 2 | 5 |
| Graduate Degree | 4 | 2 | 6 |
| Employment(Participants) | ActiveCBT | CalmCBT | Total |
|---|---|---|---|
| Other | 0 | 2 | 2 |
| Part Time | 6 | 9 | 15 |
| Full Time | 9 | 7 | 16 |
| Student | 4 | 3 | 7 |
| Income(Participants) | ActiveCBT | CalmCBT | Total |
|---|---|---|---|
| Less than $25,000 | 5 | 8 | 13 |
| $25,000-$49,999 | 1 | 5 | 6 |
| $50,000-$74,999 | 1 | 2 | 3 |
| $75,000-$99,999 | 4 | 2 | 6 |
| $100,000 or more | 8 | 4 | 12 |
3 further baseline measures are reported on the registry.
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University of Wisconsin, Madison