Treating Depression With Text Messaging

NCT05551702 | Completed

• 1 other identifier: Dep 2.0
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moderate Depression

Keywords

Cognitive Behavioral Therapy; Text-Based Intervention

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Beck Depression Inventory II at 2 Months

  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

  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 Outcomes (6)

• Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months

  Baseline, 1 Month, 2 Months, 3 Months

• Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months

  Baseline, 1 Month, 2 Months, 3 Months

• Change from Baseline Perseverative Thinking Questionnaire at 2 Months

  Baseline, 1 Month, 2 Months, 3 Months

• Change from Baseline Perseverative Thinking Questionnaire at 3 Months

  Baseline, 1 Month, 2 Months, 3 Months

• Change from Baseline Behavioral Activation for Depression Scale at 2 Months

  Baseline, 1 Month, 2 Months, 3 Months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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.

Interventions

CBT-txt BEHAVIORAL

Cognitive Behavioral Therapy delivered via automated text messaging.

Treatment

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

University of Tennessee-Knoxville

Knoxville, Tennessee, 37996, United States

Location

Related Publications (1)

• Mason MJ, Coatsworth JD, Zaharakis N, Russell M, Brown A, McKinstry S. Testing Mechanisms of Change for Text Message-Delivered Cognitive Behavioral Therapy: Randomized Clinical Trial for Young Adult Depression. JMIR Mhealth Uhealth. 2023 Jul 11;11:e45186. doi: 10.2196/45186.

  PMID: 37432723 DERIVED

Study Officials

• Michael J Mason, PhD

  University of Tennessee-Knoxville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to either the treatment group or the waitlist control group. The treatment group will receive 8 weeks of the text based intervention (CBT-txt) and complete surveys at baseline, 1 month, 2 months and 3 months. The waitlist control group will only do surveys at baseline, 1 month, 2 months, and 3 months and will then have the option of receiving the intervention after their 3 months of study participation.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 23, 2022
• Study Start: July 6, 2022
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: March 28, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)