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Cognitive Behavioral Therapy

Mindset: Therapist-guided smartphone-delivered CBT for Depression

N/A

Waitlist Available

Led By Sabine Wilhelm

Research Sponsored by Massachusetts General Hospital

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 measured at baseline, week 4, week 8 (end of treatment)

Awards & highlights

Study Summary

This trial is testing a new treatment for depression that uses a smartphone app and weekly virtual appointments with a therapist. Researchers want to know if this new treatment is usable, whether participants are satisfied with it, and whether it can help lower symptoms.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, week 4, week 8 (end of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, week 4, week 8 (end of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, week 4, week 8 (end of treatment) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

App rating (as measured by the uMARS)

Change in Outcome Expectancy (as measured by the CEQ)

Change in Patient Satisfaction (as measured by the CSQ-8)

+3 more

Secondary outcome measures

Change in Functional impairment (as measured by the WSAS)

Change in MDD symptom severity (as measured by the HAM-D)

Change in Quality of life (as measured by the Q-LES-Q-SF)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Therapist-guided smartphone-delivered CBTExperimental Treatment1 Intervention

Participants will complete app-based cognitive-behavioral therapy (CBT) treatment for major depressive disorder (MDD) through their personal mobile smartphone. They will also be assigned a therapist, who will provide brief virtual treatment sessions (up to 25 minutes via a video platform) over the course of the same treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindset: Therapist-guided smartphone-delivered CBT

2022

N/A

~30

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Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,327 Total Patients Enrolled

185 Trials studying Depression

29,556 Patients Enrolled for Depression

Koa Health B.V.Industry Sponsor

5 Previous Clinical Trials

392 Total Patients Enrolled

1 Trials studying Depression

112 Patients Enrolled for Depression

Sabine WilhelmPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

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

How many participants have been approved for this medical experiment?

"Affirmative. The clinicaltrials.gov website demonstrates that this research is in the process of enrolling individuals, with 28 participants needed from a single medical location. This trial was first posted on May 11th 2022 and its details have been revised as recently as July 28th 2022."

Answered by AI

Are there any remaining slots in this research project for participants?

"Affirmative. Clinicaltrials.gov conveys that this clinical trial is currently seeking participants, having first been posted on May 11th 2022 and most recently updated on July 28th 2022. The study necessitates the recruitment of 28 individuals from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Therapist-Guided Smartphone-Delivered CBT for MDD

Sabine Wilhelm, PhD 2022. "Therapist-Guided Smartphone-Delivered CBT for MDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05386329.