Clinical trial NCT05551702: Treating Depression With Text Messaging
Official title: Treating Depression With Text Delivered Counseling (Depression Study 2.0)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Depression
Keywords: Cognitive Behavioral Therapy
Text-Based Intervention
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline Beck Depression Inventory II at 2 Months
timeFrame: Baseline, 1 Month, 2 Month, 3 Month
measure: Change from Baseline Beck Depression Inventory II at 3 Months
timeFrame: Baseline, 1 Month, 2 Month, 3 Month
Secondary outcomes:
measure: Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months
timeFrame: Baseline, 1 Month, 2 Months, 3 Months
measure: Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months
timeFrame: Baseline, 1 Month, 2 Months, 3 Months
measure: Change from Baseline Perseverative Thinking Questionnaire at 2 Months
timeFrame: Baseline, 1 Month, 2 Months, 3 Months
measure: Change from Baseline Perseverative Thinking Questionnaire at 3 Months
timeFrame: Baseline, 1 Month, 2 Months, 3 Months
measure: Change from Baseline Behavioral Activation for Depression Scale at 2 Months
timeFrame: Baseline, 1 Month, 2 Months, 3 Months
measure: Change from Baseline Behavioral Activation for Depression Scale at 3 Months
timeFrame: Baseline, 1 Month, 2 Months, 3 Months
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee-Knoxville
state: Tennessee
Study officials:
affiliation: University of Tennessee-Knoxville
name: Michael J Mason, PhD
role: PRINCIPAL_INVESTIGATOR
References: