Treating Depression With Text Messaging

Moderate Depression Clinical Trial

Official title:

Treating Depression With Text Delivered Counseling (Depression Study 2.0)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05551702
• Other study ID #: Dep 2.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Moderate Depression

Intervention

Behavioral:
• CBT-txt
Cognitive Behavioral Therapy delivered via automated text messaging.

Locations

Country	Name	City	State
United States	University of Tennessee-Knoxville	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline, 1 Month, 2 Months, 3 Months
Secondary	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.	Baseline, 1 Month, 2 Months, 3 Months
Secondary	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.	Baseline, 1 Month, 2 Months, 3 Months
Secondary	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.	Baseline, 1 Month, 2 Months, 3 Months
Secondary	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.	Baseline, 1 Month, 2 Months, 3 Months
Secondary	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.	Baseline, 1 Month, 2 Months, 3 Months