CBT+ for Depression

NCT06001346 | Completed DMC

• 2 other identifiers: 1R61MH1294071R61MH129407-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Major Depressive Disorder

Keywords

Exercise Priming; Depression; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Goal, Task, and Bond domains each have scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance.

  Weeks 1-8 CBT+ visits

• Average change in 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 (sub-scaled). A total score (all subscales summed) will be used as a primary outcome in this study.

  Intake, Weeks 1-8 CBT+ visits, final, 12-week follow up, 1-year follow-up

Secondary Outcomes (15)

• Changes in clinician-rated depression symptoms measured by GRID-Hamilton Depression Rating Scale (GRID-HAM-D)

  Intake, final, 12-week follow up, 1-year follow up

• Change in self-reported depression symptoms measured by Patient Health Questionnaire-9 (PHQ-9)

  Intake, weeks 1-8 CBT+ visits, final, 12-week follow up, 1-year follow-up

• Change in MDD diagnosis measured by Structured Clinical Interview for DSM-5 Disorders (SCID)

  Intake, final, 12-week follow up, 1-year follow up

• Change in suicidal thoughts measured by the Columbia-Suicide Severity Rating Scale (CSSRS)

  Intake, weeks 1-8 CBT+ visits, final, 12-week follow up, 1-year follow-up

• Average anhedonia measured by Dimensional Anhedonia Rating Scale (DARS)

  Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final, 12-week follow up, 1-year follow up

Other Outcomes (3)

• Health History Questions

  Intake

• Demographic Questionnaire

  Intake

• Adverse Childhood Experience Survey (ACES)

  Intake

Study Arms (2)

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.

Behavioral: ActiveCBT

CalmCBT

ACTIVE COMPARATOR

Participants will view one of 8 standardized 30-minute nature documentary videos while resting quietly prior to therapy.

Behavioral: CalmCBT

Interventions

ActiveCBT BEHAVIORAL

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.

ActiveCBT

CalmCBT BEHAVIORAL

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.

CalmCBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50010, United States

Location

Related Publications (2)

• 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 Mar 13:121606. doi: 10.1016/j.jad.2026.121606. Online ahead of print.

  PMID: 41833616 DERIVED

• Meyer 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.

  PMID: 39375728 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)