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CBT Texts for PTSD & Hazardous Drinking (Project Better)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05372042
Recruitment Status : Recruiting
First Posted : May 12, 2022
Last Update Posted : October 31, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Kristen Lindgren, University of Washington

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Alcohol Use Behavioral: CBT Text Messages Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 28, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: CBT Text Messages
CBT skills based text messages delivered 3x per week for four weeks

Experimental: 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.
Behavioral: CBT Text Messages
CBT skills based text messages delivered 3x per week for four weeks

Experimental: 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.
Behavioral: CBT Text Messages
CBT skills based text messages delivered 3x per week for four weeks

Experimental: 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.
Behavioral: CBT Text Messages
CBT skills based text messages delivered 3x per week for four weeks

Experimental: 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.
Behavioral: CBT Text Messages
CBT skills based text messages delivered 3x per week for four weeks

Active Comparator: 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.
Behavioral: CBT Text Messages
CBT skills based text messages delivered 3x per week for four weeks




Primary Outcome Measures :
  1. Heavy Episodic Drinking [ Time Frame: month ]
    Alcohol use will be measured using items assessing heavy episodic drinking (>4/5 drinks per occasion for women/men) over the last month.

  2. Posttraumatic Stress Disorder (PTSD) [ Time Frame: month ]
    PTSD symptom severity will be measured using the PCL-5. PCL-5 will assess last month's symptoms.

  3. Typical weekly alcohol consumption [ Time Frame: month ]
    The DDQ will assess frequency and quantity of use over the last month.

  4. Alcohol Use Consequences [ Time Frame: month ]
    The SIP will assess negative consequences from alcohol use over the last month/


Secondary Outcome Measures :
  1. Risk of AUD [ Time Frame: 12 months ]
    The AUDIT will be used to assess problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months.

  2. Depression, Anxiety, Stress [ Time Frame: month ]
    The DASS will be used to assess general psychopathology symptoms over the last month.

  3. Treatment Seeking [ Time Frame: Lifetime and during study period ]
    The TSR will be included to assess treatment seeking

  4. Drug Use [ Time Frame: 3 months ]
    The CDDR will be used to assess comprehensive substance use, other than alcohol, over the last 3 months.

  5. Drug Use Problems [ Time Frame: 12 months ]
    The DAST will be included to assess problems related to other substance use and likely drug use disorder diagnosis over the last 12 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05372042


Contacts
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Contact: Ty Tristao 360-616-0260 tt88@uw.edu
Contact: Michele Bedard-Gilligan, PhD 206-616-4215 mab29@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Kristen P Lindgren, PhD    206-685-8083    KPL9716@uw.edu   
Principal Investigator: Kristen P Lindgren, PhD         
Principal Investigator: Michele Bedard-Gilligan, PhD         
Sponsors and Collaborators
University of Washington
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Kristen Lindgren, PhD University of Washington
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Responsible Party: Kristen Lindgren, Professor, School of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT05372042    
Other Study ID Numbers: STUDY00013533
1R01AA028776-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2022    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristen Lindgren, University of Washington:
hazardous drinking
posttraumatic stress disorder
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders