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CBT Texts for PTSD & Hazardous Drinking (Project Better)

Primary Purpose

Posttraumatic Stress Disorder, Alcohol Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT Text Messages
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring hazardous drinking, posttraumatic stress disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Loss Framing + Growth Mindset

Loss Framing + Simple Reminder

Gain Framing + Growth Mindset

Gain Framing + Simple Reminder

No Framing + Growth Mindset

No Framing + Simple Reminder

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Heavy Episodic Drinking
Alcohol use will be measured using items assessing heavy episodic drinking (>4/5 drinks per occasion for women/men) over the last month.
Posttraumatic Stress Disorder (PTSD)
PTSD symptom severity will be measured using the PCL-5. PCL-5 will assess last month's symptoms.
Typical weekly alcohol consumption
The DDQ will assess frequency and quantity of use over the last month.
Alcohol Use Consequences
The SIP will assess negative consequences from alcohol use over the last month/

Secondary Outcome Measures

Risk of AUD
The AUDIT will be used to assess problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months.
Depression, Anxiety, Stress
The DASS will be used to assess general psychopathology symptoms over the last month.
Treatment Seeking
The TSR will be included to assess treatment seeking
Drug Use
The CDDR will be used to assess comprehensive substance use, other than alcohol, over the last 3 months.
Drug Use Problems
The DAST will be included to assess problems related to other substance use and likely drug use disorder diagnosis over the last 12 months.

Full Information

First Posted
May 5, 2022
Last Updated
July 10, 2023
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05372042
Brief Title
CBT Texts for PTSD & Hazardous Drinking (Project Better)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Alcohol Use
Keywords
hazardous drinking, posttraumatic stress disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Loss Framing + Growth Mindset
Arm Type
Experimental
Arm Description
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.
Arm Title
Loss Framing + Simple Reminder
Arm Type
Experimental
Arm Description
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.
Arm Title
Gain Framing + Growth Mindset
Arm Type
Experimental
Arm Description
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.
Arm Title
Gain Framing + Simple Reminder
Arm Type
Experimental
Arm Description
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.
Arm Title
No Framing + Growth Mindset
Arm Type
Experimental
Arm Description
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.
Arm Title
No Framing + Simple Reminder
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT Text Messages
Intervention Description
CBT skills based text messages delivered 3x per week for four weeks
Primary Outcome Measure Information:
Title
Heavy Episodic Drinking
Description
Alcohol use will be measured using items assessing heavy episodic drinking (>4/5 drinks per occasion for women/men) over the last month.
Time Frame
month
Title
Posttraumatic Stress Disorder (PTSD)
Description
PTSD symptom severity will be measured using the PCL-5. PCL-5 will assess last month's symptoms.
Time Frame
month
Title
Typical weekly alcohol consumption
Description
The DDQ will assess frequency and quantity of use over the last month.
Time Frame
month
Title
Alcohol Use Consequences
Description
The SIP will assess negative consequences from alcohol use over the last month/
Time Frame
month
Secondary Outcome Measure Information:
Title
Risk of AUD
Description
The AUDIT will be used to assess problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months.
Time Frame
12 months
Title
Depression, Anxiety, Stress
Description
The DASS will be used to assess general psychopathology symptoms over the last month.
Time Frame
month
Title
Treatment Seeking
Description
The TSR will be included to assess treatment seeking
Time Frame
Lifetime and during study period
Title
Drug Use
Description
The CDDR will be used to assess comprehensive substance use, other than alcohol, over the last 3 months.
Time Frame
3 months
Title
Drug Use Problems
Description
The DAST will be included to assess problems related to other substance use and likely drug use disorder diagnosis over the last 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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) Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ty Tristao
Phone
360-616-0260
Email
tt88@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Bedard-Gilligan, PhD
Phone
206-616-4215
Email
mab29@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Lindgren, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen P Lindgren, PhD
Phone
206-685-8083
Email
KPL9716@uw.edu
First Name & Middle Initial & Last Name & Degree
Kristen P Lindgren, PhD
First Name & Middle Initial & Last Name & Degree
Michele Bedard-Gilligan, PhD

12. IPD Sharing Statement

Learn more about this trial

CBT Texts for PTSD & Hazardous Drinking (Project Better)

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