Cognitive Behavioral Therapy Texts for Post-Traumatic Stress Disorder and Alcohol Consumption

Overseen By Mai L Pham

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Previous participation in Project BETTER

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of text message interventions for individuals with post-traumatic stress disorder (PTSD) symptoms who also engage in harmful alcohol consumption. One group receives texts based on cognitive behavioral therapy (CBT) skills, while the other receives supportive messages. The researchers aim to determine which approach more effectively reduces PTSD symptoms and risky drinking. Individuals who experienced a traumatic event over a month ago and currently drink heavily may qualify if they reside in Washington State and have a cell phone for receiving text messages. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new methods for managing PTSD and alcohol use.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that text messages based on Cognitive Behavioral Therapy (CBT) were well-received by participants. Research shows that these messages can reduce symptoms of PTSD and risky drinking without serious side effects. Similarly, supportive text messages have proven safe and acceptable for users, also helping to lessen PTSD symptoms and drinking. Both types of text messages aim to support mental health without causing harm. Overall, participants who received these messages reported high satisfaction and no major negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using text message interventions for PTSD and alcohol consumption because they offer a unique delivery method that is accessible and convenient. Unlike traditional therapy sessions that require in-person attendance, these text messages allow participants to receive cognitive behavioral therapy (CBT) skills and supportive messages right on their phones, potentially increasing adherence and engagement. Additionally, this approach provides timely reminders and encouragement, which can help individuals apply coping skills in real-time, fostering a growth mindset and preventing future trauma-related losses. This innovative approach could make treatment more accessible to a wider audience, especially those who may have barriers to attending regular therapy sessions.

What evidence suggests that this trial's treatments could be effective for PTSD and hazardous drinking?

In this trial, participants will receive either CBT-based text messages or supportive text messages. Research has shown that text messages based on cognitive-behavioral therapy (CBT) can reduce symptoms of post-traumatic stress disorder (PTSD) and risky drinking habits. In one study, recipients of these CBT-based messages experienced improvements in PTSD symptoms and drinking behavior. These messages teach skills from CBT, a therapy that helps change negative thought patterns.

Supportive text messages, offering encouragement and hope, have also undergone study. Early research suggests these messages can be helpful, but their effects are usually not as strong as those from CBT messages. Both types of messages in this trial aim to help people manage PTSD and risky drinking. ^{1 2 3 4 5}

Who Is on the Research Team?

Michele A Bedard-Gilligan, PhD

Principal Investigator

University of Washington

Kristen P Lindgren, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Washington State who speak English, have experienced a traumatic event leading to PTSD symptoms, and engage in hazardous drinking. They must own a cell phone, agree to weekly texts for a month, and provide contact details.

Inclusion Criteria

Currently resides in WA State

Fluent in English

Reports at least one DSM-5 traumatic event that occurred 1+ months ago

Exclusion Criteria

Previous participation in Project BETTER study 1 (NCT05372042)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBT-enhanced text messages or supportive text messages for 4 weeks

4 weeks

Weekly self-reports

Follow-up

Participants are monitored for changes in PTSD and hazardous drinking symptoms

12 months

Assessments at 1, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• CBT Text Messages
• Supportive Messages

Trial Overview

The study compares two types of text message interventions: one based on Cognitive Behavioral Therapy (CBT) techniques and another offering supportive messages. It aims to see which better reduces PTSD symptoms and risky drinking behavior.

How Is the Trial Designed?

Group I: CBT text messages Active Control 1 Intervention

Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about a CBT skill, day 2 will be a remainder to use the skill that is framed 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. They will also be asked to complete weekly self-reports on PTSD and HD every Monday for four consecutive weeks.

Group II: Supportive Text Messages Active Control 1 Intervention

Participants will be sent three short supportive messages each week that include messages of support, validation, and hope. They will also be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks.

CBT Text Messages is already approved in Canada, United States for the following indications:

Approved in Canada as Cognitive Behavioral Therapy Text Messages for:

• Anxiety
• Depression
• Stress
• PTSD symptoms
• Hazardous drinking

Approved in United States as CBT-based Text Messaging for:

• PTSD symptoms
• Hazardous drinking
• Depression
• Anxiety

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Cognitive Processing Therapy (CPT) is well tolerated by veterans with comorbid PTSD and alcohol-use disorders (AUD), with no significant differences in the number of therapy sessions completed among different AUD diagnostic groups.

All veterans, regardless of their AUD status, experienced significant reductions in PTSD symptoms and depression after an average of 9 sessions of CPT, indicating that CPT is effective for treating PTSD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for veterans with comorbid PTSD and alcohol use disorders. Kaysen, D., Schumm, J., Pedersen, ER., et al.[2021]

A Web-based self-management program teaching cognitive-behavioral therapy (CBT) skills was developed to help combat veterans manage PTSD and substance use issues, addressing barriers to traditional treatment access.

Feedback from 52 combat veterans and expert clinicians led to enhancements in the program, emphasizing the importance of interactivity, privacy, and a strength-based approach to increase engagement and relevance for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Self-Management Program for Recent Combat Veterans With PTSD and Substance Misuse: Program Development and Veteran Feedback. Possemato, K., Acosta, MC., Fuentes, J., et al.[2020]

A pilot study involving 13 veterans with PTSD demonstrated that cognitive processing therapy (CPT) delivered via video teleconferencing is feasible and safe, showing significant reductions in PTSD symptoms.

There were no significant differences in treatment outcomes between the video teleconferencing and in-person groups, indicating that remote delivery of CPT can be as effective as traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive processing therapy delivered to veterans via telehealth: a pilot cohort. Morland, LA., Hynes, AK., Mackintosh, MA., et al.[2019]

In a study of 127 active-duty military personnel, those with hazardous drinking were just as likely to respond positively to cognitive processing therapy (CPT) for PTSD as those without hazardous drinking, showing that CPT is effective regardless of drinking status.

Participants with hazardous drinking not only showed significant reductions in PTSD symptoms but also had a decrease in their drinking behaviors over the course of treatment, indicating that CPT can be beneficial for both PTSD and hazardous drinking without requiring more treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment responder status and time to response as a function of hazardous drinking among active-duty military receiving variable-length cognitive processing therapy for posttraumatic stress disorder. LoSavio, ST., Straud, CL., Dondanville, KA., et al.[2023]

Integrated cognitive behaviour therapy (CBT) for PTSD and alcohol use disorders (AUD) showed that participants receiving exposure therapy had a significantly higher rate of clinically meaningful improvement in PTSD severity compared to those receiving standard alcohol-support therapy (60% vs 39%).

While both therapies reduced PTSD severity, participants in the alcohol-support group reported greater reductions in alcohol consumption and dependence, suggesting that tailored approaches may be necessary for optimal outcomes in individuals with coexisting PTSD and AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. Sannibale, C., Teesson, M., Creamer, M., et al.[2019]

In a study of 108 active duty service members with PTSD, 25% were identified as hazardous drinkers, but their PTSD symptom severity was similar to nonhazardous drinkers, indicating that hazardous drinking does not necessarily correlate with worse PTSD symptoms.

Treatment for PTSD, using group cognitive processing therapy and group present-centered therapy, did not worsen hazardous drinking; in fact, participants in the hazardous drinking group showed significant reductions in their alcohol consumption after receiving PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of Treatment Effects on Hazardous Drinking Among Service Members With Posttraumatic Stress Disorder. Dondanville, KA., Wachen, JS., Hale, WJ., et al.[2020]

In an 8-week trial involving 45 service members with PTSD, self-management cognitive behavior therapy (CBT) showed significant reductions in PTSD symptoms and depression compared to supportive counseling.

One-third of participants who completed the self-management CBT achieved high-end state functioning at 6 months, suggesting it could be an effective treatment option for those with limited access to traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Litz, BT., Engel, CC., Bryant, RA., et al.[2019]

Cognitive Processing Therapy-Cognitive only version (CPT-C) delivered via videoteleconferencing (VTC) was found to be as effective as in-person treatment for veterans with PTSD, with significant reductions in PTSD symptoms observed immediately after treatment and maintained at 3 and 6 months follow-up.

The study, which included 125 veterans over 12 sessions, demonstrated high levels of therapeutic alliance and satisfaction, indicating that VTC can effectively increase access to mental health care for those in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder delivered to rural veterans via telemental health: a randomized noninferiority clinical trial. Morland, LA., Mackintosh, MA., Greene, CJ., et al.[2022]

A pilot study involving 109 participants tested a brief text message intervention based on cognitive behavioral therapy (CBT) and message framing, showing high feasibility and acceptability for individuals with co-occurring PTSD and alcohol misuse.

The CBT + Framing intervention demonstrated significant reductions in PTSD symptoms and heavy drinking episodes compared to a supportive control group, although results varied across different waves of the study, indicating the need for further research on effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study on the feasibility, acceptability, and preliminary efficacy of a brief text message intervention for co-occurring alcohol misuse and PTSD symptoms in a community sample. Bedard-Gilligan, MA., Dworkin, ER., Kaysen, D., et al.[2022]

A 12-week course of modified Cognitive Processing Therapy (CPT-C) effectively improved PTSD symptoms and reduced alcohol dependence in a combat veteran, showing promise for treating co-occurring conditions.

The veteran maintained significant improvements in both PTSD and alcohol-related issues 12 weeks after completing the treatment, suggesting the long-term efficacy of this enhanced therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report on the use of cognitive processing therapy-cognitive, enhanced to address heavy alcohol use. McCarthy, E., Petrakis, I.[2022]

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