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OpenTrials
Completed

NCT Number: NCT05551702

Treating Depression With Text Messaging

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.

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Key information

Conditions

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee-Knoxville

Knoxville, Tennessee, 37996, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT-txt

Behavioral

Cognitive Behavioral Therapy delivered via automated text messaging.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Registry information

Official study title

Treating Depression With Text Delivered Counseling (Depression Study 2.0)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2022
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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