Treating Depression with Text Messaging

March 24, 2025 updated by: Michael Mason, The University of Tennessee, Knoxville

Treating Depression with Text Delivered Counseling (Depression Study 2.0)

The purpose of the research study is to investigate whether CBT-txt, a counseling program delivered by text messages is effective in stopping or reducing depressive symptoms. CBT-txt is based on a counseling program that has been proven to reduce depression when delivered in-person and on the web, but has not yet been tested or shown to be effective when delivered by text.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, participants will complete online screening assessments. Once eligibility is confirmed, participants will be randomized either to the intervention group or to the waitlist-control group. Those who are randomized to the intervention group will receive the 8-week text intervention via smartphone and complete assessments at baseline, 1 month, 2 months, and 3 months. Those who are randomized to the waitlist-control group will only complete the assessments at baseline, 1 month, 2 months, and 3 months. Participants who are initially assigned to the waitlist-control group can choose to receive the text intervention once their 3-month participation is complete.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • 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 Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • University of Tennessee-Knoxville

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

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 25 years old
  • a score of at least 5 on the PHQ-9 (indicating elevated depression symptoms

Exclusion Criteria:

  • treatment for depression during the past three months
  • endorse suicide ideation on the PHQ-9*
  • lack of access to a text-capable phone
  • unable or unwilling to commit to two months of follow-up
  • not fluent in English.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
This arm will receive 8 weeks of the text-based intervention (CBT-txt). CBT-txt is a version of Cognitive Behavioral Therapy tailored to be delivered by automated text message. This arm will also complete surveys at baseline, 1 month, 2 months, and 3 months.
Behavioral: CBT-txt
Cognitive Behavioral Therapy delivered via automated text messaging.
No Intervention: Waitlist Control
This arm will not receive the text-based intervention during study participation. These participants will only complete surveys at baseline, 1 month, 2 months, and 3 months and will be given the option to receive CBT-txt after they complete study participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Beck Depression Inventory II at 2 Months
Time Frame: Baseline, 1 Month, 2 Month, 3 Month
A 21-item instrument for measuring the severity of depression in adults and adolescents aged 13 years and older. Minimum score =0, Maximum=63. Higher scores indicate more depression.
Baseline, 1 Month, 2 Month, 3 Month
Change from Baseline Beck Depression Inventory II at 3 Months
Time Frame: Baseline, 1 Month, 2 Month, 3 Month
A 21-item instrument for measuring the severity of depression in adults and adolescents aged 13 years and older. Minimum score =0, Maximum=63. Higher scores indicate more depression.
Baseline, 1 Month, 2 Month, 3 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months
Time Frame: Baseline, 1 Month, 2 Months, 3 Months
A 10 item scale using scenarios to help recognize cognitive distortions. Minimum score = 20, Maximum = 140. Higher scores equal more cognitive distortions.
Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months
Time Frame: Baseline, 1 Month, 2 Months, 3 Months
A 10 item scale using scenarios to help recognize cognitive distortions. Minimum score = 20, Maximum = 140. Higher scores equal more cognitive distortions.
Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Perseverative Thinking Questionnaire at 2 Months
Time Frame: Baseline, 1 Month, 2 Months, 3 Months
A 15 item scale rating statements about negative experiences or problems to identify repetitive negative thinking. Minimum score = 0, Max 60. Higher scores equal more perseverative thinking.
Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Perseverative Thinking Questionnaire at 3 Months
Time Frame: Baseline, 1 Month, 2 Months, 3 Months
A 15 item scale rating statements about negative experiences or problems to identify repetitive negative thinking. Minimum score = 0, Max 60. Higher scores equal more perseverative thinking.
Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Behavioral Activation for Depression Scale at 2 Months
Time Frame: Baseline, 1 Month, 2 Months, 3 Months
A 9 items scale to measure how and when participants become activated during behavioral activation treatment. Minimum score = 0, Max = 54. Higher scores equal more behavioral activation.
Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Behavioral Activation for Depression Scale at 3 Months
Time Frame: Baseline, 1 Month, 2 Months, 3 Months
A 9 items scale to measure how and when participants become activated during behavioral activation treatment. Minimum score = 0, Max = 54. Higher scores equal more behavioral activation.
Baseline, 1 Month, 2 Months, 3 Months

Collaborators and Investigators

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

Sponsor

The University of Tennessee, Knoxville

Investigators

  • Principal Investigator: Michael J Mason, PhD, University of Tennessee-Knoxville

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)

July 6, 2022

Primary Completion (Actual)

January 8, 2025

Study Completion (Actual)

January 8, 2025

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dep 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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