Moderate DepressionNCT05551702
Treating Depression With Text Messaging
A study testing CBT-txt in people with Moderate Depression, run by The University of Tennessee, Knoxville at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Moderate Depression
- What is being tested?
- CBT-txt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to 8 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 25 years old
- a score of at least 5 on the PHQ-9 (indicating elevated depression symptoms
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee-Knoxville
Knoxville, Tennessee, 37996
About this study
Official title: Treating Depression With Text Delivered Counseling (Depression Study 2.0)
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.
Read the 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.
- Conditions
- Moderate Depression
- Being tested
- CBT-txt
- Keywords
- Cognitive Behavioral Therapy, Text-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-txtBehavioural
Cognitive Behavioral Therapy delivered via automated text messaging.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Behavioral: CBT-txt |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 Month, 2 Month, 3 Month
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.
Measured: Baseline, 1 Month, 2 Month, 3 Month
Secondary outcomes (6)
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.
Measured: Baseline, 1 Month, 2 Months, 3 Months
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.
Measured: Baseline, 1 Month, 2 Months, 3 Months
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.
Measured: Baseline, 1 Month, 2 Months, 3 Months
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.
Measured: Baseline, 1 Month, 2 Months, 3 Months
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.
Measured: Baseline, 1 Month, 2 Months, 3 Months
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.
Measured: Baseline, 1 Month, 2 Months, 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start6 Jul 2022
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Mason, The University of Tennessee, Knoxville
- Investigators
- Michael J Mason, PhD, Principal investigator, University of Tennessee-Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551702
- Sponsor's protocol ID
- Dep 2.0
- Status last verified
- May 2024
- First submitted
- 13 Sep 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mason MJ, Coatsworth JD, Zaharakis N, Russell M, Brown A, McKinstry S. Testing Mechanisms of Change for Text Message-Delivered Cognitive Behavioral Therapy: Randomized Clinical Trial for Young Adult Depression. JMIR Mhealth Uhealth. 2023 Jul 11;11:e45186. doi: 10.2196/45186.
PubMed 37432723
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Depression With Text Delivered Counseling (Depression Study 2.0)
- ClinicalTrials.gov ID
- NCT05551702
- Acronym / sponsor ID
- Dep 2.0
- Conditions
- Moderate Depression
- Keywords
- Cognitive Behavioral Therapy, Text-Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: CBT-txtThis 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 25 years old
- a score of at least 5 on the PHQ-9 (indicating elevated depression symptoms
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-txtCognitive Behavioral Therapy delivered via automated text messaging. | Behavioural | Treatment |
Primary outcome
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.
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.
6 secondary outcomes
Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months
Time frame: Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months
Time frame: Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Perseverative Thinking Questionnaire at 2 Months
Time frame: Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Perseverative Thinking Questionnaire at 3 Months
Time frame: Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Behavioral Activation for Depression Scale at 2 Months
Time frame: Baseline, 1 Month, 2 Months, 3 Months
Change from Baseline Behavioral Activation for Depression Scale at 3 Months
Time frame: Baseline, 1 Month, 2 Months, 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 37432723Mason MJ, Coatsworth JD, Zaharakis N, Russell M, Brown A, McKinstry S. Testing Mechanisms of Change for Text Message-Delivered Cognitive Behavioral Therapy: Randomized Clinical Trial for Young Adult Depression. JMIR Mhealth Uhealth. 2023 Jul 11;11:e45186. doi: 10.2196/45186.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Mason, PhD principal investigator
University of Tennessee-Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-txt in people with Moderate Depression, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Beck Depression Inventory II at 2 Months (time frame: Baseline, 1 Month, 2 Month, 3 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05551702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.