Cognitive Behavioral Training for PTSD and Alcoholism

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of South Dakota

Disqualifiers: Psychosis, Severe AUD, Suicidal ideation, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The present study seeks to increase understanding of Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD) among veterans, an important public health concern. We will study the effects of regulatory deficits and sleep disturbance on the dynamic course of PTSD and AUD. The study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, AUD symptoms, and PTSD symptoms in the real world.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Cognitive Behavioral Training for PTSD and Alcoholism?

Research shows that cognitive behavioral therapy (CBT) can significantly reduce symptoms of both PTSD and alcohol use disorder (AUD) when used together. Studies found that integrated CBT for PTSD and AUD led to substantial improvements in PTSD severity and alcohol-related outcomes, suggesting that this combined approach can be effective for individuals with both conditions. ^{1 2 3 4 5}

Is Cognitive Behavioral Training for PTSD and Alcoholism safe for humans?

Research on cognitive behavioral therapy (CBT) for PTSD and alcohol use disorders shows that it is generally well-tolerated by patients, with favorable outcomes in reducing symptoms and improving quality of life. There is no indication of significant safety concerns in the studies reviewed. ^{2 3 4 5 6}

How does Cognitive Behavioral Training for PTSD and Alcoholism differ from other treatments?

Cognitive Behavioral Training for PTSD and Alcoholism is unique because it integrates cognitive behavior therapy (CBT) specifically for both PTSD and alcohol use disorders, focusing on exposure therapy to address PTSD symptoms. This approach contrasts with traditional treatments that may separately address PTSD and alcoholism, potentially leading to more significant improvements in PTSD symptoms when both conditions are treated together. ^{3 4 7 8 9}

Research Team

Eligibility Criteria

This trial is for OIF/OEF/OND veterans at risk for PTSD (with a PCL-5 score of 33 or higher) and/or AUD (AUDIT score of at least 7 for women, 8 for men). It's not suitable for individuals with active suicidal/homicidal thoughts, psychosis, severe alcohol use disorder, high risk or treatment history for sleep apnea.

Inclusion Criteria

This study is not open to veterans who served in the military operations in Iraq, Afghanistan, or other locations.

You have a high risk of developing post-traumatic stress disorder (PTSD) or alcohol use disorder (AUD).

Exclusion Criteria

I am at high risk for sleep apnea or am being treated for it.

Psychosis or severe Alcohol Use Disorder that contraindicates participation (based on interview)

Active suicidal or homicidal ideation that contraindicates participation (based on interview)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a short, computerized training in the laboratory to alter maladaptive response biases

Short-term

Follow-up

Participants are monitored for changes in PTSD and AUD symptoms over time

2 years

Treatment Details

Interventions

• Alcohol CBM (Behavioural Intervention)
• Alcohol Sham (Behavioural Intervention)
• PTSD CBM (Behavioural Intervention)
• PTSD Sham (Behavioural Intervention)

Trial Overview The study examines the impact of computerized training aimed to modify harmful response tendencies and lessen the link between sleep issues, emotional and behavioral dysregulation, AUD symptoms, and PTSD symptoms in real-world settings among veterans.

Participant Groups

Group I: Alcohol Sham + PTSD CBM Experimental Treatment 2 Interventions

Group II: Alcohol Cognitive Bias Modification (CBM) + PTSD CBM Experimental Treatment 2 Interventions

Group III: Alcohol CBM + PTSD Sham Experimental Treatment 2 Interventions

Group IV: Alcohol Sham + PTSD Sham Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

University of South Dakota

Lead Sponsor

Trials

16

Recruited

2,000+

Bay Pines VA Healthcare System

Collaborator

Trials

2

Recruited

250+

Sioux Falls VA Health Care System

Collaborator

Trials

2

Recruited

2,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

The pilot randomized clinical trial evaluated a new treatment called TIPSS, which combines cognitive processing therapy with standard cognitive-behavioral therapy for substance use disorders, specifically targeting individuals with both PTSD and substance use disorders.

Participants received 12 sessions over six weeks, and the study aims to assess whether TIPSS can effectively reduce PTSD symptoms and substance use compared to standard CBT, while also exploring mechanisms like distress tolerance and cue reactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a novel, integrated cognitive-behavioral therapy for co-occurring posttraumatic stress and substance use disorders: A pilot randomized clinical trial. Vujanovic, AA., Smith, LJ., Green, CE., et al.[2021]

A new cognitive behavioral therapy (CBT) for PTSD was adapted for patients in community addiction treatment, showing promising results in a study involving 11 patients.

The therapy led to favorable outcomes in reducing PTSD severity, substance use, and improving patient retention, indicating it could be an effective treatment option for those with co-occurring PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive behavioral therapy for co-occurring substance use and posttraumatic stress disorders. McGovern, MP., Lambert-Harris, C., Acquilano, S., et al.[2022]

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 pilot study involving 43 veterans with PTSD and alcohol use disorder, Acceptance and Commitment Therapy (ACT) led to significant reductions in PTSD symptoms and alcohol-related issues, with 67% of participants completing the treatment protocol.

Improvements in quality of life and reductions in depressive symptoms were also observed, suggesting that ACT is a promising treatment option for individuals with co-occurring PTSD and AUD, particularly when mindfulness practices are emphasized.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy for Co-Occurring Posttraumatic Stress Disorder and Alcohol Use Disorders in Veterans: Pilot Treatment Outcomes. Meyer, EC., Walser, R., Hermann, B., et al.[2019]

Behavioral interventions for treating alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) include a variety of evidence-based approaches, such as relapse prevention and cognitive processing therapy, which can help improve outcomes for individuals with these conditions.

Integrated treatment models that address both AUD and PTSD simultaneously may be more effective than sequential treatments, highlighting the need for further research to tailor interventions based on individual characteristics like gender and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Treatments for Alcohol Use Disorder and Post-Traumatic Stress Disorder. Flanagan, JC., Jones, JL., Jarnecke, AM., et al.[2023]

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]

Over half (52.20%) of respondents with PTSD reported moderate to excessive alcohol use during the war, with 22.92% consuming more alcohol post-war than before, indicating a strong link between PTSD and increased alcohol consumption as a form of self-medication.

Treating alcoholism in PTSD patients is challenging due to the complex interplay of trauma and addiction, which can create significant emotional strain on healthcare providers, similar to the experiences of those treating patients with other severe conditions like AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PTSD and alcoholism. Gruden, V., Gruden, V., Gruden, Z.[2015]

Vietnam veterans with alcoholism and PTSD benefit from a structured treatment program that emphasizes early support for self-esteem and guilt reduction, which helps them address deeper emotional issues later on.

The program avoids the use of benzodiazepines after detoxification and focuses on building trust and discussing combat experiences in a supportive environment, highlighting the importance of family and peer support in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcoholism treatment of Vietnam veterans with post-traumatic stress disorder. Schnitt, JM., Nocks, JJ.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of a novel, integrated cognitive-behavioral therapy for co-occurring posttraumatic stress and substance use disorders: A pilot randomized clinical trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A cognitive behavioral therapy for co-occurring substance use and posttraumatic stress disorders. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy for Co-Occurring Posttraumatic Stress Disorder and Alcohol Use Disorders in Veterans: Pilot Treatment Outcomes. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Behavioral Treatments for Alcohol Use Disorder and Post-Traumatic Stress Disorder. [2023]

6. United States 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. [2023]

7. Croatia pubmed.ncbi.nlm.nih.gov

PTSD and alcoholism. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Alcoholism treatment of Vietnam veterans with post-traumatic stress disorder. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

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