Major Depressive DisorderCBT+NCT06001346
CBT+ for Depression
A study testing ActiveCBT and CalmCBT in people with Major Depressive Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ActiveCBT and CalmCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- ActiveCBT, CalmCBT
- Keywords
- Exercise Priming, Depression, Cognitive Behavioral Therapy
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveCBTBehavioural
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.
CalmCBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ActiveCBT | Experimental | 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. Receives: Behavioral: ActiveCBT |
| CalmCBT | Active comparator | Participants will view one of 8 standardized 30-minute nature documentary videos while resting quietly prior to therapy. Receives: Behavioral: CalmCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Intake, Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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').
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1-8 CBT+ visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001346
- Sponsor's protocol ID
- 1R61MH129407
- Other IDs
- 1R61MH129407-01A1
- Acronym
- CBT+
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2023
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meyer JD, Kelly SJE, Gidley JM, Lansing JE, Smith SL, Churchill SL, Connolly ML, Thomas EBK, Goldberg SB, Abercrombie HC, Murray TA, Wade NG. Exercise priming to enhance therapeutic bond and behavioral activation in CBT for MDD: a randomized controlled target-engagement trial with remission signal. J Affect Disord. 2026 Jul 15;405:121606. doi: 10.1016/j.jad.2026.121606. Epub 2026 Mar 13.
PubMed 41833616Meyer JD, Kelly SJE, Gidley JM, Lansing JE, Smith SL, Churchill SL, Thomas EBK, Goldberg SB, Abercrombie HC, Murray TA, Wade NG. Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial). Trials. 2024 Oct 7;25(1):663. doi: 10.1186/s13063-024-08495-x.
PubMed 39375728
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ActiveCBT for Depression: Transforming Treatment Through Exercise Priming
- ClinicalTrials.gov ID
- NCT06001346
- Acronym / sponsor ID
- CBT+ / 1R61MH129407
- Conditions
- Major Depressive Disorder
- Keywords
- Exercise Priming, Depression, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 30 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ActiveCBT | Experimental | Behavioral: ActiveCBTParticipants 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. |
| CalmCBT | Active comparator | Behavioral: CalmCBTParticipants will view one of 8 standardized 30-minute nature documentary videos while resting quietly prior to therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveCBTParticipants 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. | Behavioural | ActiveCBT |
| CalmCBTParticipants 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. | Behavioural | CalmCBT |
Primary outcome
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.
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.
9 secondary outcomes
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
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
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
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])
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])
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)
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
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
Average Session Effectiveness Measured by Session Evaluation Questionnaire (SEQ)
Time frame: Weeks 1-8 CBT+ visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41833616Meyer JD, Kelly SJE, Gidley JM, Lansing JE, Smith SL, Churchill SL, Connolly ML, Thomas EBK, Goldberg SB, Abercrombie HC, Murray TA, Wade NG. Exercise priming to enhance therapeutic bond and behavioral activation in CBT for MDD: a randomized controlled target-engagement trial with remission signal. J Affect Disord. 2026 Jul 15;405:121606. doi: 10.1016/j.jad.2026.121606. Epub 2026 Mar 13.
- Derived from this study: PubMed 39375728Meyer JD, Kelly SJE, Gidley JM, Lansing JE, Smith SL, Churchill SL, Thomas EBK, Goldberg SB, Abercrombie HC, Murray TA, Wade NG. Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial). Trials. 2024 Oct 7;25(1):663. doi: 10.1186/s13063-024-08495-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveCBT and CalmCBT in people with Major Depressive Disorder, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Self-reported Working Alliance Measured by Working Alliance Inventory (WAI) (time frame: Weeks 1-8 CBT+ visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001346, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.