Skip to content

CBT Texts for PTSD & Hazardous Drinking (Project Better)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05372042
Enrollment
505
Registered
2022-05-12
Start date
2022-10-31
Completion date
2024-04-25
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use, Posttraumatic Stress Disorder

Keywords

hazardous drinking, posttraumatic stress disorder

Brief 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. 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).

Interventions

CBT skills based text messages delivered 3x per week for four weeks

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 18+ years of age 2. Currently resides in WA State 3. Fluent in English 4. Reports at least one DSM-5 traumatic event that occurred 1+ months ago 5. Current PTSD severity of 33+ on the PCL-5 6. 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) 7. Owns a functioning cellular phone 8. Is willing to receive weekly study text messages for 4 consecutive weeks 9. Is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment)

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Heavy Episodic DrinkingBaseline, 4 weeks, 8 weeks, 16 weeksHeavy 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)Baseline, 4 weeks, 8 weeks, and 16 weeksThe 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 ConsumptionBaseline, 4 weeks, 8 weeks, 16 weeksThe 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 ConsequencesBaseline, 4 weeks, 8 weeks, 16 weeksThe 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.

Secondary

MeasureTime frameDescription
Risk of Alcohol Use Disorder (AUD)Baseline,16 weeksThe 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.
Drug Use ProblemsBaseline, 16 weeksThe 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.
Depression, Anxiety, and Stress ScaleBaseline, 8 weeks, 16 weeksThe 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.
Treatment Seeking16 weeksThe 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.
Drug UseBaseline,16 weeksThe 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.

Countries

United States

Participant flow

Pre-assignment details

2,751 completed the screening survey, and 1,397 of them were not eligible. Among 1,354 participants who were eligible for the verification call, 628 were excluded prior to verification call due to suspected fraud, missing contact information, etc. and 162 did not show up/declined participation. Among 564 participants who were sent baseline survey, 45 never completed baseline and 14 were identified as fraudulent upon review. 505 completed baseline/enrolled and were randomized.

Participants by arm

ArmCount
Loss Framing + Growth Mindset
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. CBT Text Messages: CBT skills based text messages delivered 3x per week for four weeks
84
Loss Framing + Simple Reminder
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. CBT Text Messages: CBT skills based text messages delivered 3x per week for four weeks
83
Gain Framing + Growth Mindset
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. CBT Text Messages: CBT skills based text messages delivered 3x per week for four weeks
86
Gain Framing + Simple Reminder
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. CBT Text Messages: CBT skills based text messages delivered 3x per week for four weeks
85
No Framing + Growth Mindset
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. CBT Text Messages: CBT skills based text messages delivered 3x per week for four weeks
85
No Framing + Simple Reminder
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. CBT Text Messages: CBT skills based text messages delivered 3x per week for four weeks
82
Total505

Baseline characteristics

CharacteristicLoss Framing + Growth MindsetLoss Framing + Simple ReminderGain Framing + Growth MindsetGain Framing + Simple ReminderNo Framing + Growth MindsetNo Framing + Simple ReminderTotal
Age, Continuous36.45 years
STANDARD_DEVIATION 10.98
38.06 years
STANDARD_DEVIATION 12.04
36.83 years
STANDARD_DEVIATION 10.7
35.99 years
STANDARD_DEVIATION 11.05
34.47 years
STANDARD_DEVIATION 10.19
35.82 years
STANDARD_DEVIATION 11.17
36.27 years
STANDARD_DEVIATION 11.03
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants6 Participants7 Participants12 Participants9 Participants12 Participants56 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
70 Participants71 Participants75 Participants72 Participants76 Participants69 Participants433 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants6 Participants4 Participants1 Participants0 Participants1 Participants16 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants1 Participants2 Participants4 Participants2 Participants13 Participants
Race (NIH/OMB)
Asian
4 Participants2 Participants2 Participants6 Participants4 Participants2 Participants20 Participants
Race (NIH/OMB)
Black or African American
2 Participants4 Participants2 Participants2 Participants4 Participants4 Participants18 Participants
Race (NIH/OMB)
More than one race
12 Participants9 Participants7 Participants14 Participants10 Participants10 Participants62 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants5 Participants0 Participants4 Participants4 Participants15 Participants
Race (NIH/OMB)
White
64 Participants64 Participants69 Participants61 Participants59 Participants60 Participants377 Participants
Sex/Gender, Customized
Another identity
10 Participants7 Participants7 Participants4 Participants4 Participants2 Participants34 Participants
Sex/Gender, Customized
Female
55 Participants60 Participants59 Participants61 Participants63 Participants62 Participants360 Participants
Sex/Gender, Customized
Male
17 Participants15 Participants18 Participants16 Participants16 Participants17 Participants99 Participants
Sex/Gender, Customized
Transgender
2 Participants1 Participants2 Participants4 Participants2 Participants1 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 840 / 830 / 860 / 850 / 850 / 82
other
Total, other adverse events
0 / 840 / 830 / 860 / 850 / 850 / 82
serious
Total, serious adverse events
0 / 840 / 830 / 860 / 850 / 850 / 82

Outcome results

Primary

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.

Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Loss Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Month 1 follow-up (Week 8)4.68 score on a scaleStandard Deviation 3.92
Loss Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Post-intervention (Week 4)5.87 score on a scaleStandard Deviation 3.9
Loss Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Pre-intervention (Baseline)8.99 score on a scaleStandard Deviation 3.65
Loss Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Month 3 follow-up (Week 16)4.65 score on a scaleStandard Deviation 4.41
Loss Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Post-intervention (Week 4)6.54 score on a scaleStandard Deviation 4.15
Loss Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Month 3 follow-up (Week 16)5.06 score on a scaleStandard Deviation 5.07
Loss Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Month 1 follow-up (Week 8)5.99 score on a scaleStandard Deviation 5.1
Loss Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Pre-intervention (Baseline)9.00 score on a scaleStandard Deviation 3.65
Gain Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Pre-intervention (Baseline)8.22 score on a scaleStandard Deviation 4.07
Gain Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Month 3 follow-up (Week 16)4.55 score on a scaleStandard Deviation 4.76
Gain Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Month 1 follow-up (Week 8)4.84 score on a scaleStandard Deviation 4.59
Gain Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Post-intervention (Week 4)5.54 score on a scaleStandard Deviation 4.33
Gain Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Pre-intervention (Baseline)9.02 score on a scaleStandard Deviation 3.87
Gain Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Month 3 follow-up (Week 16)4.83 score on a scaleStandard Deviation 4.73
Gain Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Month 1 follow-up (Week 8)4.95 score on a scaleStandard Deviation 4.55
Gain Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Post-intervention (Week 4)6.14 score on a scaleStandard Deviation 4.44
No Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Post-intervention (Week 4)5.16 score on a scaleStandard Deviation 4.31
No Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Month 3 follow-up (Week 16)4.55 score on a scaleStandard Deviation 5.05
No Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Month 1 follow-up (Week 8)4.76 score on a scaleStandard Deviation 4.82
No Framing + Growth MindsetAlcohol Use ConsequencesTimepoint: Pre-intervention (Baseline)8.33 score on a scaleStandard Deviation 4.06
No Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Month 3 follow-up (Week 16)3.49 score on a scaleStandard Deviation 4.24
No Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Month 1 follow-up (Week 8)5.09 score on a scaleStandard Deviation 4.72
No Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Post-intervention (Week 4)5.83 score on a scaleStandard Deviation 4.34
No Framing + Simple ReminderAlcohol Use ConsequencesTimepoint: Pre-intervention (Baseline)9.28 score on a scaleStandard Deviation 3.74
Primary

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.

Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Loss Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Month 1 follow-up (Week 8)3.27 number of heavy drinking episodesStandard Deviation 3.5
Loss Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Post-intervention (Week 4)3.71 number of heavy drinking episodesStandard Deviation 3.4
Loss Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Month 3 follow-up (Week 16)2.53 number of heavy drinking episodesStandard Deviation 2.98
Loss Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Pre-intervention (Baseline)6.19 number of heavy drinking episodesStandard Deviation 3.03
Loss Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Month 1 follow-up (Week 8)3.82 number of heavy drinking episodesStandard Deviation 3.71
Loss Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Pre-intervention (Baseline)6.00 number of heavy drinking episodesStandard Deviation 3.15
Loss Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Post-intervention (Week 4)4.58 number of heavy drinking episodesStandard Deviation 3.73
Loss Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Month 3 follow-up (Week 16)3.61 number of heavy drinking episodesStandard Deviation 3.75
Gain Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Month 3 follow-up (Week 16)3.18 number of heavy drinking episodesStandard Deviation 3.4
Gain Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Month 1 follow-up (Week 8)3.32 number of heavy drinking episodesStandard Deviation 3.27
Gain Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Pre-intervention (Baseline)5.85 number of heavy drinking episodesStandard Deviation 3.2
Gain Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Post-intervention (Week 4)3.63 number of heavy drinking episodesStandard Deviation 3.45
Gain Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Month 1 follow-up (Week 8)3.48 number of heavy drinking episodesStandard Deviation 3.61
Gain Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Pre-intervention (Baseline)6.69 number of heavy drinking episodesStandard Deviation 3.12
Gain Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Month 3 follow-up (Week 16)3.65 number of heavy drinking episodesStandard Deviation 3.7
Gain Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Post-intervention (Week 4)4.52 number of heavy drinking episodesStandard Deviation 3.47
No Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Month 3 follow-up (Week 16)3.04 number of heavy drinking episodesStandard Deviation 3.33
No Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Pre-intervention (Baseline)6.02 number of heavy drinking episodesStandard Deviation 3.12
No Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Post-intervention (Week 4)3.48 number of heavy drinking episodesStandard Deviation 3.43
No Framing + Growth MindsetHeavy Episodic DrinkingTimepoint: Month 1 follow-up (Week 8)3.01 number of heavy drinking episodesStandard Deviation 3.38
No Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Month 3 follow-up (Week 16)2.33 number of heavy drinking episodesStandard Deviation 3.01
No Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Post-intervention (Week 4)4.03 number of heavy drinking episodesStandard Deviation 3.44
No Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Month 1 follow-up (Week 8)2.96 number of heavy drinking episodesStandard Deviation 3.31
No Framing + Simple ReminderHeavy Episodic DrinkingTimepoint: Pre-intervention (Baseline)6.33 number of heavy drinking episodesStandard Deviation 3.22
Primary

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.

Time frame: Baseline, 4 weeks, 8 weeks, and 16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Loss Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Month 3 follow-up (Week 16)33.72 score on a scaleStandard Deviation 15.34
Loss Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Pre-intervention (Baseline)51.83 score on a scaleStandard Deviation 11.43
Loss Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Month 1 follow-up (Week 8)34.19 score on a scaleStandard Deviation 14.87
Loss Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Post-intervention (Week 4)39.72 score on a scaleStandard Deviation 15.23
Loss Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Pre-intervention (Baseline)49.99 score on a scaleStandard Deviation 11.97
Loss Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Month 3 follow-up (Week 16)34.64 score on a scaleStandard Deviation 18.6
Loss Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Month 1 follow-up (Week 8)37.73 score on a scaleStandard Deviation 14.9
Loss Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Post-intervention (Week 4)38.85 score on a scaleStandard Deviation 15.75
Gain Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Month 1 follow-up (Week 8)38.46 score on a scaleStandard Deviation 14.39
Gain Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Pre-intervention (Baseline)50.66 score on a scaleStandard Deviation 11.43
Gain Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Post-intervention (Week 4)38.78 score on a scaleStandard Deviation 14.3
Gain Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Month 3 follow-up (Week 16)36.53 score on a scaleStandard Deviation 15.27
Gain Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Pre-intervention (Baseline)51.67 score on a scaleStandard Deviation 11.87
Gain Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Month 3 follow-up (Week 16)36.61 score on a scaleStandard Deviation 15.36
Gain Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Month 1 follow-up (Week 8)37.18 score on a scaleStandard Deviation 15.4
Gain Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Post-intervention (Week 4)39.38 score on a scaleStandard Deviation 15.91
No Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Post-intervention (Week 4)39.40 score on a scaleStandard Deviation 14.91
No Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Month 1 follow-up (Week 8)35.83 score on a scaleStandard Deviation 16.27
No Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Month 3 follow-up (Week 16)34.23 score on a scaleStandard Deviation 16.36
No Framing + Growth MindsetPosttraumatic Stress Disorder (PTSD)Timepoint: Pre-intervention (Baseline)51.66 score on a scaleStandard Deviation 11.44
No Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Month 3 follow-up (Week 16)31.51 score on a scaleStandard Deviation 16.79
No Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Post-intervention (Week 4)39.06 score on a scaleStandard Deviation 15.72
No Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Month 1 follow-up (Week 8)35.14 score on a scaleStandard Deviation 14.23
No Framing + Simple ReminderPosttraumatic Stress Disorder (PTSD)Timepoint: Pre-intervention (Baseline)51.33 score on a scaleStandard Deviation 11.95
Primary

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.

Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Loss Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Pre-intervention (Baseline)23.96 number of standard drinks per weekStandard Deviation 22.19
Loss Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Post-intervention (Week 4)16.65 number of standard drinks per weekStandard Deviation 19.06
Loss Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Month 1 follow-up (Week 8)14.85 number of standard drinks per weekStandard Deviation 18.24
Loss Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Month 3 follow-up (Week 16)11.80 number of standard drinks per weekStandard Deviation 12.86
Loss Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Month 1 follow-up (Week 8)17.24 number of standard drinks per weekStandard Deviation 16.85
Loss Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Post-intervention (Week 4)21.49 number of standard drinks per weekStandard Deviation 19.47
Loss Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Pre-intervention (Baseline)26.00 number of standard drinks per weekStandard Deviation 18.5
Loss Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Month 3 follow-up (Week 16)17.88 number of standard drinks per weekStandard Deviation 22.83
Gain Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Month 3 follow-up (Week 16)17.05 number of standard drinks per weekStandard Deviation 23.15
Gain Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Month 1 follow-up (Week 8)16.46 number of standard drinks per weekStandard Deviation 20.16
Gain Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Post-intervention (Week 4)19.72 number of standard drinks per weekStandard Deviation 18.91
Gain Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Pre-intervention (Baseline)26.00 number of standard drinks per weekStandard Deviation 26.01
Gain Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Pre-intervention (Baseline)26.15 number of standard drinks per weekStandard Deviation 22.98
Gain Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Month 3 follow-up (Week 16)16.24 number of standard drinks per weekStandard Deviation 17.6
Gain Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Post-intervention (Week 4)18.67 number of standard drinks per weekStandard Deviation 13.9
Gain Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Month 1 follow-up (Week 8)16.48 number of standard drinks per weekStandard Deviation 15.21
No Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Month 1 follow-up (Week 8)15.89 number of standard drinks per weekStandard Deviation 23.41
No Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Month 3 follow-up (Week 16)14.46 number of standard drinks per weekStandard Deviation 23.58
No Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Post-intervention (Week 4)18.20 number of standard drinks per weekStandard Deviation 19.71
No Framing + Growth MindsetTypical Weekly Alcohol ConsumptionTimepoint: Pre-intervention (Baseline)23.68 number of standard drinks per weekStandard Deviation 20.97
No Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Post-intervention (Week 4)17.96 number of standard drinks per weekStandard Deviation 16.46
No Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Month 1 follow-up (Week 8)14.79 number of standard drinks per weekStandard Deviation 16.57
No Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Month 3 follow-up (Week 16)11.47 number of standard drinks per weekStandard Deviation 13.78
No Framing + Simple ReminderTypical Weekly Alcohol ConsumptionTimepoint: Pre-intervention (Baseline)25.63 number of standard drinks per weekStandard Deviation 20.8
Secondary

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.

Time frame: Baseline, 8 weeks, 16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Loss Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Depression11.15 score on a scaleStandard Deviation 4.67
Loss Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Depression8.93 score on a scaleStandard Deviation 5.34
Loss Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Anxiety7.00 score on a scaleStandard Deviation 4.64
Loss Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Anxiety6.88 score on a scaleStandard Deviation 3.86
Loss Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Anxiety7.92 score on a scaleStandard Deviation 3.89
Loss Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Depression9.40 score on a scaleStandard Deviation 5.15
Loss Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Depression12.12 score on a scaleStandard Deviation 4.89
Loss Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Depression9.69 score on a scaleStandard Deviation 5.46
Loss Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Depression9.16 score on a scaleStandard Deviation 6.25
Loss Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Anxiety8.37 score on a scaleStandard Deviation 4.74
Loss Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Anxiety6.83 score on a scaleStandard Deviation 4.01
Loss Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Anxiety6.26 score on a scaleStandard Deviation 4.76
Gain Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Anxiety7.14 score on a scaleStandard Deviation 4.49
Gain Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Anxiety8.70 score on a scaleStandard Deviation 4.04
Gain Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Depression10.22 score on a scaleStandard Deviation 5.7
Gain Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Depression10.73 score on a scaleStandard Deviation 5.42
Gain Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Anxiety6.64 score on a scaleStandard Deviation 4.74
Gain Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Depression12.13 score on a scaleStandard Deviation 4.87
Gain Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Anxiety7.24 score on a scaleStandard Deviation 4.82
Gain Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Depression8.95 score on a scaleStandard Deviation 5.65
Gain Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Anxiety9.33 score on a scaleStandard Deviation 3.96
Gain Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Anxiety7.15 score on a scaleStandard Deviation 4.25
Gain Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Depression12.44 score on a scaleStandard Deviation 4.97
Gain Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Depression9.40 score on a scaleStandard Deviation 5.53
No Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Anxiety6.85 score on a scaleStandard Deviation 4.47
No Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Anxiety6.27 score on a scaleStandard Deviation 4.02
No Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Depression8.96 score on a scaleStandard Deviation 5.61
No Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Anxiety9.05 score on a scaleStandard Deviation 4.29
No Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Depression9.61 score on a scaleStandard Deviation 6.03
No Framing + Growth MindsetDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Depression11.79 score on a scaleStandard Deviation 4.95
No Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Depression11.59 score on a scaleStandard Deviation 4.69
No Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Anxiety5.90 score on a scaleStandard Deviation 4.2
No Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 1 follow-up (Week 8), Depression8.98 score on a scaleStandard Deviation 5.55
No Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Anxiety6.00 score on a scaleStandard Deviation 4.08
No Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Month 3 follow-up (Week 16), Depression8.55 score on a scaleStandard Deviation 5.12
No Framing + Simple ReminderDepression, Anxiety, and Stress ScaleTimepoint: Pre-intervention (Baseline), Anxiety8.45 score on a scaleStandard Deviation 4.27
Secondary

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.

Time frame: Baseline,16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Loss Framing + Growth MindsetDrug UseTimepoint: Month 3 follow-up (Week 16)2.18 score on a scaleStandard Deviation 2.04
Loss Framing + Growth MindsetDrug UseTimepoint: Pre-intervention (Baseline)3.82 score on a scaleStandard Deviation 2.6
Loss Framing + Simple ReminderDrug UseTimepoint: Month 3 follow-up (Week 16)2.00 score on a scaleStandard Deviation 1.67
Loss Framing + Simple ReminderDrug UseTimepoint: Pre-intervention (Baseline)4.24 score on a scaleStandard Deviation 3.12
Gain Framing + Growth MindsetDrug UseTimepoint: Pre-intervention (Baseline)3.51 score on a scaleStandard Deviation 2.5
Gain Framing + Growth MindsetDrug UseTimepoint: Month 3 follow-up (Week 16)2.00 score on a scaleStandard Deviation 2.25
Gain Framing + Simple ReminderDrug UseTimepoint: Pre-intervention (Baseline)3.61 score on a scaleStandard Deviation 2.74
Gain Framing + Simple ReminderDrug UseTimepoint: Month 3 follow-up (Week 16)1.87 score on a scaleStandard Deviation 1.94
No Framing + Growth MindsetDrug UseTimepoint: Pre-intervention (Baseline)3.79 score on a scaleStandard Deviation 3.17
No Framing + Growth MindsetDrug UseTimepoint: Month 3 follow-up (Week 16)1.86 score on a scaleStandard Deviation 2.12
No Framing + Simple ReminderDrug UseTimepoint: Month 3 follow-up (Week 16)1.81 score on a scaleStandard Deviation 2.03
No Framing + Simple ReminderDrug UseTimepoint: Pre-intervention (Baseline)4.05 score on a scaleStandard Deviation 3.11
Secondary

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.

Time frame: Baseline, 16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Loss Framing + Growth MindsetDrug Use ProblemsTimepoint: Month 3 follow-up (Week 16)2.32 score on a scaleStandard Deviation 2.48
Loss Framing + Growth MindsetDrug Use ProblemsTimepoint: Pre-intervention (Baseline)3.24 score on a scaleStandard Deviation 2.66
Loss Framing + Simple ReminderDrug Use ProblemsTimepoint: Month 3 follow-up (Week 16)2.38 score on a scaleStandard Deviation 2.68
Loss Framing + Simple ReminderDrug Use ProblemsTimepoint: Pre-intervention (Baseline)3.60 score on a scaleStandard Deviation 3.23
Gain Framing + Growth MindsetDrug Use ProblemsTimepoint: Pre-intervention (Baseline)2.86 score on a scaleStandard Deviation 2.64
Gain Framing + Growth MindsetDrug Use ProblemsTimepoint: Month 3 follow-up (Week 16)1.67 score on a scaleStandard Deviation 2.35
Gain Framing + Simple ReminderDrug Use ProblemsTimepoint: Month 3 follow-up (Week 16)2.36 score on a scaleStandard Deviation 3.04
Gain Framing + Simple ReminderDrug Use ProblemsTimepoint: Pre-intervention (Baseline)3.06 score on a scaleStandard Deviation 3.08
No Framing + Growth MindsetDrug Use ProblemsTimepoint: Pre-intervention (Baseline)2.87 score on a scaleStandard Deviation 3.01
No Framing + Growth MindsetDrug Use ProblemsTimepoint: Month 3 follow-up (Week 16)1.79 score on a scaleStandard Deviation 2.44
No Framing + Simple ReminderDrug Use ProblemsTimepoint: Month 3 follow-up (Week 16)1.81 score on a scaleStandard Deviation 2.57
No Framing + Simple ReminderDrug Use ProblemsTimepoint: Pre-intervention (Baseline)3.48 score on a scaleStandard Deviation 2.95
Secondary

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.

Time frame: Baseline,16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Loss Framing + Growth MindsetRisk of Alcohol Use Disorder (AUD)Timepoint: Pre-intervention (Baseline)18.29 score on a scaleStandard Deviation 7.35
Loss Framing + Growth MindsetRisk of Alcohol Use Disorder (AUD)Timepoint: Month 3 follow-up (Week 16)12.93 score on a scaleStandard Deviation 7.26
Loss Framing + Simple ReminderRisk of Alcohol Use Disorder (AUD)Timepoint: Pre-intervention (Baseline)18.49 score on a scaleStandard Deviation 7.02
Loss Framing + Simple ReminderRisk of Alcohol Use Disorder (AUD)Timepoint: Month 3 follow-up (Week 16)15.63 score on a scaleStandard Deviation 8.06
Gain Framing + Growth MindsetRisk of Alcohol Use Disorder (AUD)Timepoint: Pre-intervention (Baseline)18.17 score on a scaleStandard Deviation 8.35
Gain Framing + Growth MindsetRisk of Alcohol Use Disorder (AUD)Timepoint: Month 3 follow-up (Week 16)14.12 score on a scaleStandard Deviation 8.06
Gain Framing + Simple ReminderRisk of Alcohol Use Disorder (AUD)Timepoint: Pre-intervention (Baseline)18.89 score on a scaleStandard Deviation 8.38
Gain Framing + Simple ReminderRisk of Alcohol Use Disorder (AUD)Timepoint: Month 3 follow-up (Week 16)15.21 score on a scaleStandard Deviation 8.78
No Framing + Growth MindsetRisk of Alcohol Use Disorder (AUD)Timepoint: Pre-intervention (Baseline)17.72 score on a scaleStandard Deviation 9.01
No Framing + Growth MindsetRisk of Alcohol Use Disorder (AUD)Timepoint: Month 3 follow-up (Week 16)14.19 score on a scaleStandard Deviation 9.43
No Framing + Simple ReminderRisk of Alcohol Use Disorder (AUD)Timepoint: Pre-intervention (Baseline)18.54 score on a scaleStandard Deviation 7.18
No Framing + Simple ReminderRisk of Alcohol Use Disorder (AUD)Timepoint: Month 3 follow-up (Week 16)13.23 score on a scaleStandard Deviation 7.82
Secondary

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.

Time frame: 16 weeks

ArmMeasureValue (MEAN)Dispersion
Loss Framing + Growth MindsetTreatment Seeking0.61 unique mental health treatmentsStandard Deviation 1.03
Loss Framing + Simple ReminderTreatment Seeking0.49 unique mental health treatmentsStandard Deviation 0.8
Gain Framing + Growth MindsetTreatment Seeking0.43 unique mental health treatmentsStandard Deviation 0.73
Gain Framing + Simple ReminderTreatment Seeking0.82 unique mental health treatmentsStandard Deviation 1.19
No Framing + Growth MindsetTreatment Seeking0.47 unique mental health treatmentsStandard Deviation 0.92
No Framing + Simple ReminderTreatment Seeking0.42 unique mental health treatmentsStandard Deviation 0.88

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026