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Behavioural Intervention

Enhanced Cognitive Behavioral Therapy for Depression (CBT+ Trial)

N/A

Recruiting

Research Sponsored by Iowa State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

CBT+ Trial Summary

This trial will investigate whether exercising before therapy sessions can improve the effects of cognitive behavioral therapy on depression.

Who is the study for?

Adults aged 18-65 with Major Depressive Disorder (MDD), experiencing mild to severe depression, can join this study. They must be new to CBT and not currently pregnant or nursing. Participants should be physically able to exercise and not have a history of psychosis, mania, bipolar disorder, substance use disorders, or pose a risk of harm.Check my eligibility

What is being tested?

The trial is testing two versions of CBT for depression: 'CalmCBT' involves resting before therapy sessions while 'ActiveCBT' includes moderate exercise beforehand. The goal is to see if exercising affects the benefits of CBT over eight weeks.See study design

What are the potential side effects?

Since this trial involves cognitive behavioral therapy and light to moderate exercise, side effects may include typical reactions associated with physical activity such as muscle soreness or fatigue.

CBT+ Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average change in self-reported behavioral activation measured by Behavioral Activation for Depression Scale (BADS)

Average self-reported working alliance measured by Working Alliance Inventory (WAI)

Secondary outcome measures

Average Lyssn generated scores

Average anhedonia measured by Dimensional Anhedonia Rating Scale (DARS)

Average anhedonia measured by an Anhedonia Visual Analogue Scale (Anhedonia VAS)

+12 more

Other outcome measures

Adverse Childhood Experience Survey (ACES)

Demographic Questionnaire

Health History Questions

CBT+ Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ActiveCBTExperimental Treatment1 Intervention

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.

Group II: CalmCBTActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Iowa State UniversityLead Sponsor

59 Previous Clinical Trials

144,513 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,669 Total Patients Enrolled

666 Trials studying Depression

251,544 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the registration process for this trial still open?

"According to clinicaltrials.gov, this clinical trial is currently searching for individuals to participate in the study which was initially posted on September 1st 2023 and last modified on September 26th 2023."

Answered by AI

Is this clinical experiment limited to persons under 35, or are those of more advanced age also eligible?

"For this clinical trial, the age range for potential participants falls between 18 and 65. Nevertheless, there are over 200 studies available to those below 18 years of age, with 1,021 options for individuals aged beyond 65."

Answered by AI

What is the upper limit of individuals engaging in this examination?

"Affirmative. Clinicaltrials.gov's information indicates that this clinical trial is currently recruiting patients, with 40 participants being sought out from 1 location since its first posting on September 1st 2023 and last update on the 26th of the same month."

Answered by AI

What are the major goals of this clinical experiment?

"This clinical trial's primary outcome to be measured during Weeks 1-8 of CBT+ visits is the Average change in self-reported behavioral activation as assessed by the Behavioral Activation for Depression Scale (BADS). Additional outcomes encompass a Change in suicidal thoughts using Columbia-Suicide Severity Rating Scale (CSSRS) which has 5 ordinal points from 'wish to be dead' to 'suicidal intent with plan', an Average Anhedonia score measured through an Anhedonia Visual Analog Scale, and finally Serum Brain Derived Neurotrophic Factor (BDNF) checked via Enzyme Linked Immunosorbent Ass"

Answered by AI

Could I be a viable participant in this clinical experiment?

"This medical trial seeks 40 patients aged 18-65 diagnosed with DSM-5 Major Depressive Disorder (MDD) according to the Structured Clinical Interview for DSM-5. The participants should present current depressive symptoms of at least mild severity, and they must not be engaging in any mental health treatment or have a stable regimen that will remain unchanged throughout the duration of the intervention. Additionally, all applicants must pass a Physical Activity Readiness Questionnaire and never had structured Cognitive Behavioral Therapy (CBT)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CBT+ for Depression

Jacob Meyer 2023. "CBT+ for Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001346.