Treating Depression With Text Messaging

Sponsor
The University of Tennessee, Knoxville (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05551702
Collaborator
(none)
103
1
2
4.9
21.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CBT-txt
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Treating Depression With Text Delivered Counseling (Depression Study 2.0)
Actual Study Start Date :
Jul 6, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Beck Depression Inventory II at 2 Months [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.

  2. Change from Baseline Beck Depression Inventory II at 3 Months [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.

Secondary Outcome Measures

  1. Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months [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.

  2. Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months [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.

  3. Change from Baseline Perseverative Thinking Questionnaire at 2 Months [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.

  4. Change from Baseline Perseverative Thinking Questionnaire at 3 Months [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.

  5. Change from Baseline Behavioral Activation for Depression Scale at 2 Months [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.

  6. Change from Baseline Behavioral Activation for Depression Scale at 3 Months [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Tennessee-Knoxville Knoxville Tennessee United States 37996

Sponsors and Collaborators

  • The University of Tennessee, Knoxville

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Mason, Principal Investigator, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier:
NCT05551702
Other Study ID Numbers:
  • Dep 2.0
First Posted:
Sep 23, 2022
Last Update Posted:
Sep 23, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Mason, Principal Investigator, The University of Tennessee, Knoxville
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2022