CBT+ for Depression (CBT+)

August 4, 2026 updated by: University of Wisconsin, Madison

ActiveCBT for Depression: Transforming Treatment Through Exercise Priming

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Iowa
      • Ames, Iowa, United States, 50010
        • Iowa State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with DSM-5 MDD, confirmed via SCID.
  • Having current depressive symptoms of at least mild severity defined by HAM-D rating ≥8.
  • Being between age 18 and 65.
  • Either not engaging in any mental health treatment (e.g., medication, psychological, or behavioral) OR on a stable mental health treatment regimen and willing to maintain it for the length of the intervention.
  • Willing and safe to exercise based on the Physical Activity Readiness Questionnaire.
  • Being CBT-naïve (as defined by never undergoing structured CBT).

Exclusion Criteria:

  • currently pregnant, nursing, or planning to become pregnant,
  • severe obesity (BMI=40)
  • diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
  • diagnosed with current Substance Use Disorder, via the SCID
  • pose an imminent risk of self-harm or harm to others, assessed via the C-SSRS
  • exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, assessed by clinical research personnel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ActiveCBT
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 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.
Active Comparator: CalmCBT
Participants will view one of 8 standardized 30-minute nature documentary videos while resting quietly prior to therapy.
Behavioral: CalmCBT
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Self-reported Working Alliance Measured by Working Alliance Inventory (WAI)
Time Frame: Weeks 1-8 CBT+ visits
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.
Weeks 1-8 CBT+ visits
Self-reported Behavioral Activation Measured by Behavioral Activation for Depression Scale (BADS)
Time Frame: Intake, Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
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.
Intake, Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Clinician-rated Depression Symptoms Measured by GRID-Hamilton Depression Rating Scale (GRID-HAM-D) From Intake
Time Frame: Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
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.
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
Time Frame: Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
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.
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)
Time Frame: Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
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').
Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Average Anhedonia Measured by Dimensional Anhedonia Rating Scale (DARS)
Time Frame: Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy])
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.
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)
Time Frame: Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy])
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.
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)
Time Frame: Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
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+ 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
Time Frame: Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
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.
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)
Time Frame: Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
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.
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)
Time Frame: Weeks 1-8 CBT+ visits
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.
Weeks 1-8 CBT+ visits

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nature Connectedness Index (NCI)
Time Frame: Intake, Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
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.
Intake, Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
Health History Questions
Time Frame: Intake
Health history will be self-reported. In addition, participants will be asked to list their current medications.
Intake
Demographic Questionnaire
Time Frame: Intake
Demographic characteristics including age, sex, race, education, marital status, occupational status, and household income will be recorded or measured to characterize the sample.
Intake
Adverse Childhood Experience Survey (ACES)
Time Frame: Intake
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).
Intake
Average Lyssn Generated Scores
Time Frame: Weeks 1-8 CBT+ visits
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.
Weeks 1-8 CBT+ visits
Change in Monitor-assessed Physical Activity Measured by Accelerometry
Time Frame: Intake, weeks 4 & 8 CBT+ visits (monitors worn 1 week following each time point)
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).
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)
Time Frame: Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
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).
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)
Time Frame: Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
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.
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)
Time Frame: Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
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.
Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R61MH129407 (U.S. NIH Grant/Contract)
  • 1R61MH129407-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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