Posttraumatic Stress DisorderNCT05372042
CBT Texts for PTSD & Hazardous Drinking (Project Better)
A study testing CBT Text Messages in people with Posttraumatic Stress Disorder and Alcohol Use, run by University of Washington at 1 site in United States.
Trial summary
The research study seeks to refine and test a brief, self-directed, intervention for individuals from the general public with PTSD and co-occurring HD that can be delivered via text-messaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Alcohol Use
- What is being tested?
- CBT Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- Currently resides in WA State
- Fluent in English
- Reports at least one DSM-5 traumatic event that occurred 1+ months ago
- Current PTSD severity of 33+ on the PCL-5
- Current hazardous alcohol use (2+ heavy episodic drinking occasions [4+ drinks on one occasion for women, 5+ drinks on one occasion for men] in past month, 1+ negative consequences related to alcohol use)
Show all 9Show fewer
- Owns a functioning cellular phone
- Is willing to receive weekly study text messages for 4 consecutive weeks
- Is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Efficacy of a CBT-enhanced Text Message Intervention to Reduce Symptom Burden in Individuals With Post-traumatic Stress Disorder Symptoms and Co-occurring Hazardous Drinking
The research study seeks to refine and test a brief, self-directed, intervention for individuals from the general public with PTSD and co-occurring HD that can be delivered via text-messaging. This application seeks to refine the intervention further by testing whether theoretically-driven, evidence-based strategies from basic cognitive psychology (message framing) and social psychology (facilitating growth mindsets) result in better outcomes for PTSD symptoms and HD by addressing pilot participant feedback related to avoidance and motivation.
Read the detailed description
This study will refine a previously piloted text message intervention by integrating and testing the efficacy of behavioral nudge and psychologically-wise intervention techniques when added to CBT text messages for reducing hazardous drinking (HD) and PTSD symptoms.The enhancements will be tested in a fully crossed 3 (message framing: avoid losses vs. maximize gains vs. no framing) x 2 (mindsets: facilitate growth mindset reminder vs. simple reminder to use skills) factorial design to identify the most effective combination of text messages. A sample of 500 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, immediate post-, 1-, and 3-month assessments will capture change in primary outcomes (PTSD, hazardous drinking).
Trauma exposure and PTSD symptoms will be assessed using the Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 with the Life Events Checklist (PCL-5 and LEC).
HD will be assessed via a set of measures that provide a detailed picture of drinking patterns. First, two questions will ask about heavy episodic drinking (HED: 4/5 or more drinks per single occasion for men/women) episodes, assessing both frequency over the lifetime and frequency over the last month. Typical weekly alcohol consumption will also be assessed using the Daily Drinking Questionnaire (DDQ). Negative alcohol-related consequences will be assessed via the Short Index of Problems (SIP).
- Conditions
- Posttraumatic Stress Disorder, Alcohol Use
- Being tested
- CBT Text Messages
- Keywords
- hazardous drinking, posttraumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT Text MessagesBehavioural
CBT skills based text messages delivered 3x per week for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Loss Framing + Growth Mindset | Experimental | Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward preventing future losses from trauma exposure, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. Receives: Behavioral: CBT Text Messages |
| Loss Framing + Simple Reminder | Experimental | Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward prevent future losses from trauma exposure, and day 3 will have a simple reminder to use the skill. Receives: Behavioral: CBT Text Messages |
| Gain Framing + Growth Mindset | Experimental | Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward future benefits from doing so, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. Receives: Behavioral: CBT Text Messages |
| Gain Framing + Simple Reminder | Experimental | Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward future benefits from doing so, and day 3 will have a simple reminder to use the skill. Receives: Behavioral: CBT Text Messages |
| No Framing + Growth Mindset | Experimental | Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that has no framing, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. Receives: Behavioral: CBT Text Messages |
| No Framing + Simple Reminder | Active comparator | Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that has no framing, and day 3 will have a simple reminder to use the skill. Receives: Behavioral: CBT Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy Episodic Drinking
Heavy Episodic Drinking (HED) assesses the quantity of heavy drinking episodes (i.e., >4/5 drinks per occasion for women/men, based on the National Institute of Alcohol Abuse and Alcoholism's definition) over the last month. It is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). The range of the scale is 0-10 (count of the number of heavy drinking episodes in the last month); 10 is described as 10 or more heavy drinking episodes. Higher scores represent a greater number of heavy drinking episodes.
Measured: Baseline, 4 weeks, 8 weeks, 16 weeks
Posttraumatic Stress Disorder (PTSD)
The Posttraumatic Stress Disorder Checklist for the 5th Edition of Diagnostic and Statistical Manual of Mental Disorders (PCL-5) assesses the severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the 5th Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16) to assess change in PTSD symptoms. The range of the scale is 0-80. Higher scores represent more severe PTSD symptoms.
Measured: Baseline, 4 weeks, 8 weeks, and 16 weeks
Typical Weekly Alcohol Consumption
The Daily Drinking Questionnaire (DDQ) assesses the number of standard drinks consumed each day of a typical week over the last month and is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). The range for the scale to report drinks consumed each day is 0-25. Each day's score for the week is summed to created a total number of drinks consumed per week; the count of drinks consumed per week ranges from 0 to 175. Higher scores representing greater number of drinks consumed during a typical week.
Measured: Baseline, 4 weeks, 8 weeks, 16 weeks
Alcohol Use Consequences
The Short Index of Problems (SIP) assesses the negative consequences from alcohol consumption over the last month and is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). The range for the scale is 0-15 and higher scores represent a greater number of alcohol-related consequences.
Measured: Baseline, 4 weeks, 8 weeks, 16 weeks
Secondary outcomes (5)
Risk of Alcohol Use Disorder (AUD)
The Alcohol Use Disorders Identification Test (AUDIT) assesses problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months and is administered at pre-intervention (baseline) and 3 month follow up (week 16). The total range of scores is 0-40 and higher scores represent greater risks of having an alcohol use disorder.
Measured: Baseline,16 weeks
Depression, Anxiety, and Stress Scale
The Depression Anxiety Stress Scale (DASS-21) assesses the general psychopathology symptoms over the last month and is administered at pre-intervention (baseline), 1 month follow up (week 8), and 3 month follow up (week 16). It has 3 subscales; two of which (anxiety and depression subscales) are outcomes for this study. The total range of scores of the anxiety subscale of the DASS-21 is 0-21 and higher scores indicate more severe symptoms. The total range of scores of the depression subscale of the DASS-21 is 0-21 and higher scores indicate more severe symptoms.
Measured: Baseline, 8 weeks, 16 weeks
Treatment Seeking
The Treatment Services Received (TSR) assesses the types of mental health and addictions treatments that individuals (e.g., inpatient, outpatient, 12-step, etc) received since enrolling in the study and is administered at 3 month follow up (week 16). Twelve types of treatment are listed and counted to calculate the number of types of treatment that individuals received over the 16-week study period. The minimum possible score is 0 (no services received) and the maximum is 12 types of treatment. Higher numbers indicate receiving more types of treatment.
Measured: 16 weeks
Drug Use
The Customary Drinking and Drug Use Record (CDDR) assesses comprehensive substance use, other than alcohol, over the last 3 months and is administered at pre-intervention (baseline) and 3 month follow up (week 16). The total range of scores is 0-12 and higher scores indicate more drug use.
Measured: Baseline,16 weeks
Drug Use Problems
The Drug Abuse Screening Test (DAST-10) assesses the problems related to other substance use and likely drug use disorder diagnosis over the last 12 months and is administered at pre-intervention (baseline) and 3 month follow up (week 16). The total range of scores is 0-10 and higher scores indicate more substance use-related problems and likely drug use disorder diagnosis.
Measured: Baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start31 Oct 2022
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- Participants will receive text messages 3 days a week for a 4 week period. To keep text messages within the length of standard SMS limits (160 characters), each day's message will be sent in the form of two brief texts (each will be 160 characters or less). The content of the text messages will vary as a function of condition. Participants will be assigned to CBT text messages plus one of six combinations of framing (3: loss vs. gain vs. no framing) and mindsets (2: growth vs reminder) texts. The combination that consists of no framing and simple reminder is an active comparator as it is the version of CBT text messages closest to what has been tested previously.
- Masking
- None (open label)
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kristen Lindgren, University of Washington
- Investigators
- Kristen Lindgren, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372042
- Sponsor's protocol ID
- STUDY00013533
- Other IDs
- 1R01AA028776-01A1
- Status last verified
- Jun 2025
- First submitted
- 5 May 2022
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of a CBT-enhanced Text Message Intervention to Reduce Symptom Burden in Individuals With Post-traumatic Stress Disorder Symptoms and Co-occurring Hazardous Drinking
- ClinicalTrials.gov ID
- NCT05372042
- Acronym / sponsor ID
- STUDY00013533
- Conditions
- Posttraumatic Stress Disorder, Alcohol Use
- Keywords
- hazardous drinking, posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research study seeks to refine and test a brief, self-directed, intervention for individuals from the general public with PTSD and co-occurring HD that can be delivered via text-messaging. This application seeks to refine the intervention further by testing whether theoretically-driven, evidence-based strategies from basic cognitive psychology (message framing) and social psychology (facilitating growth mindsets) result in better outcomes for PTSD symptoms and HD by addressing pilot participant feedback related to avoidance and motivation.
Detailed description
This study will refine a previously piloted text message intervention by integrating and testing the efficacy of behavioral nudge and psychologically-wise intervention techniques when added to CBT text messages for reducing hazardous drinking (HD) and PTSD symptoms.The enhancements will be tested in a fully crossed 3 (message framing: avoid losses vs. maximize gains vs. no framing) x 2 (mindsets: facilitate growth mindset reminder vs. simple reminder to use skills) factorial design to identify the most effective combination of text messages. A sample of 500 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, immediate post-, 1-, and 3-month assessments will capture change in primary outcomes (PTSD, hazardous drinking).
Trauma exposure and PTSD symptoms will be assessed using the Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 with the Life Events Checklist (PCL-5 and LEC).
HD will be assessed via a set of measures that provide a detailed picture of drinking patterns. First, two questions will ask about heavy episodic drinking (HED: 4/5 or more drinks per single occasion for men/women) episodes, assessing both frequency over the lifetime and frequency over the last month. Typical weekly alcohol consumption will also be assessed using the Daily Drinking Questionnaire (DDQ). Negative alcohol-related consequences will be assessed via the Short Index of Problems (SIP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Participants will receive text messages 3 days a week for a 4 week period. To keep text messages within the length of standard SMS limits (160 characters), each day's message will be sent in the form of two brief texts (each will be 160 characters or less). The content of the text messages will vary as a function of condition. Participants will be assigned to CBT text messages plus one of six combinations of framing (3: loss vs. gain vs. no framing) and mindsets (2: growth vs reminder) texts. The combination that consists of no framing and simple reminder is an active comparator as it is the version of CBT text messages closest to what has been tested previously.
| Arm | Type | Receives |
|---|---|---|
| Loss Framing + Growth Mindset | Experimental | Behavioral: CBT Text MessagesParticipants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward preventing future losses from trauma exposure, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. |
| Loss Framing + Simple Reminder | Experimental | Behavioral: CBT Text MessagesParticipants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward prevent future losses from trauma exposure, and day 3 will have a simple reminder to use the skill. |
| Gain Framing + Growth Mindset | Experimental | Behavioral: CBT Text MessagesParticipants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward future benefits from doing so, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. |
| Gain Framing + Simple Reminder | Experimental | Behavioral: CBT Text MessagesParticipants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward future benefits from doing so, and day 3 will have a simple reminder to use the skill. |
| No Framing + Growth Mindset | Experimental | Behavioral: CBT Text MessagesParticipants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that has no framing, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. |
| No Framing + Simple Reminder | Active comparator | Behavioral: CBT Text MessagesParticipants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that has no framing, and day 3 will have a simple reminder to use the skill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18+ years of age
- Currently resides in WA State
- Fluent in English
- Reports at least one DSM-5 traumatic event that occurred 1+ months ago
- Current PTSD severity of 33+ on the PCL-5
Key exclusion criteria (1 listed)
- -
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 Text MessagesCBT skills based text messages delivered 3x per week for four weeks | Behavioural | Gain Framing + Growth Mindset, Gain Framing + Simple Reminder, Loss Framing + Growth Mindset, Loss Framing + Simple Reminder, No Framing + Growth Mindset, No Framing + Simple Reminder |
Primary outcome
Heavy Episodic Drinking
Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks
Heavy Episodic Drinking (HED) assesses the quantity of heavy drinking episodes (i.e., >4/5 drinks per occasion for women/men, based on the National Institute of Alcohol Abuse and Alcoholism's definition) over the last month. It is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). The range of the scale is 0-10 (count of the number of heavy drinking episodes in the last month); 10 is described as 10 or more heavy drinking episodes. Higher scores represent a greater number of heavy drinking episodes.
Posttraumatic Stress Disorder (PTSD)
Time frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
The Posttraumatic Stress Disorder Checklist for the 5th Edition of Diagnostic and Statistical Manual of Mental Disorders (PCL-5) assesses the severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the 5th Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16) to assess change in PTSD symptoms. The range of the scale is 0-80. Higher scores represent more severe PTSD symptoms.
Typical Weekly Alcohol Consumption
Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks
The Daily Drinking Questionnaire (DDQ) assesses the number of standard drinks consumed each day of a typical week over the last month and is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). The range for the scale to report drinks consumed each day is 0-25. Each day's score for the week is summed to created a total number of drinks consumed per week; the count of drinks consumed per week ranges from 0 to 175. Higher scores representing greater number of drinks consumed during a typical week.
Alcohol Use Consequences
Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks
The Short Index of Problems (SIP) assesses the negative consequences from alcohol consumption over the last month and is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). The range for the scale is 0-15 and higher scores represent a greater number of alcohol-related consequences.
5 secondary outcomes
Risk of Alcohol Use Disorder (AUD)
Time frame: Baseline,16 weeks
Depression, Anxiety, and Stress Scale
Time frame: Baseline, 8 weeks, 16 weeks
Treatment Seeking
Time frame: 16 weeks
Drug Use
Time frame: Baseline,16 weeks
Drug Use Problems
Time frame: Baseline, 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kristen Lindgren, PhD principal investigator
University of Washington
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 Text Messages in people with Posttraumatic Stress Disorder and Alcohol Use, run by University of Washington 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 9 inclusion and 1 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 26 Jun 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?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Heavy Episodic Drinking (time frame: Baseline, 4 weeks, 8 weeks, 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.