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Treating Depression With Text Messaging

Primary Purpose

Moderate Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-txt
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Depression focused on measuring Cognitive Behavioral Therapy, Text-Based Intervention

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Tennessee-Knoxville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months
A 10 item scale using scenarios to help recognize cognitive distortions. Minimum score = 20, Maximum = 140. Higher scores equal more cognitive distortions.
Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months
A 10 item scale using scenarios to help recognize cognitive distortions. Minimum score = 20, Maximum = 140. Higher scores equal more cognitive distortions.
Change from Baseline Perseverative Thinking Questionnaire at 2 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.
Change from Baseline Perseverative Thinking Questionnaire at 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.
Change from Baseline Behavioral Activation for Depression Scale at 2 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.
Change from Baseline Behavioral Activation for Depression Scale at 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.

Full Information

First Posted
September 13, 2022
Last Updated
May 8, 2023
Sponsor
The University of Tennessee, Knoxville
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1. Study Identification

Unique Protocol Identification Number
NCT05551702
Brief Title
Treating Depression With Text Messaging
Official Title
Treating Depression With Text Delivered Counseling (Depression Study 2.0)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Depression
Keywords
Cognitive Behavioral Therapy, Text-Based Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT-txt
Intervention Description
Cognitive Behavioral Therapy delivered via automated text messaging.
Primary Outcome Measure Information:
Title
Change from Baseline Beck Depression Inventory II at 2 Months
Description
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.
Time Frame
Baseline, 1 Month, 2 Month, 3 Month
Title
Change from Baseline Beck Depression Inventory II at 3 Months
Description
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.
Time Frame
Baseline, 1 Month, 2 Month, 3 Month
Secondary Outcome Measure Information:
Title
Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months
Description
A 10 item scale using scenarios to help recognize cognitive distortions. Minimum score = 20, Maximum = 140. Higher scores equal more cognitive distortions.
Time Frame
Baseline, 1 Month, 2 Months, 3 Months
Title
Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months
Description
A 10 item scale using scenarios to help recognize cognitive distortions. Minimum score = 20, Maximum = 140. Higher scores equal more cognitive distortions.
Time Frame
Baseline, 1 Month, 2 Months, 3 Months
Title
Change from Baseline Perseverative Thinking Questionnaire at 2 Months
Description
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.
Time Frame
Baseline, 1 Month, 2 Months, 3 Months
Title
Change from Baseline Perseverative Thinking Questionnaire at 3 Months
Description
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.
Time Frame
Baseline, 1 Month, 2 Months, 3 Months
Title
Change from Baseline Behavioral Activation for Depression Scale at 2 Months
Description
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.
Time Frame
Baseline, 1 Month, 2 Months, 3 Months
Title
Change from Baseline Behavioral Activation for Depression Scale at 3 Months
Description
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.
Time Frame
Baseline, 1 Month, 2 Months, 3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Mason, PhD
Organizational Affiliation
University of Tennessee-Knoxville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee-Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Treating Depression With Text Messaging

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