Cognitive Behavioral Training for PTSD and Alcoholism

Not currently recruiting at 2 trial locations

Overseen By Raluca M Simons, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of South Dakota

Disqualifiers: Psychosis, Severe AUD, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Short-term

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how short, computerized training can help veterans manage PTSD and Alcohol Use Disorder (AUD). Researchers seek to determine if this training can reduce issues like sleep problems and emotional responses. Participants will be divided into groups to receive different types of training, such as Alcohol Cognitive Behavioral Modification (Alcohol CBM), PTSD Cognitive Behavioral Modification (PTSD CBM), or a placebo (inactive treatment) to measure effectiveness. Veterans who have served in conflicts like Iraq or Afghanistan and are at risk for PTSD or AUD may be suitable candidates for this trial. As an unphased trial, this study offers veterans the opportunity to contribute to innovative research that could improve mental health treatments.

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.

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

Research has shown that cognitive behavioral modification (CBM) treatments for alcohol use disorder (AUD) and PTSD are generally well-tolerated. For Alcohol CBM, studies indicate that this therapy often helps individuals change negative thoughts about alcohol use and is considered safe for those with both AUD and PTSD, with few serious side effects reported.

Similarly, PTSD CBM treatments have demonstrated promising safety results. Research has found that these talk therapies for PTSD usually do not cause major side effects. They focus on teaching coping skills and changing harmful thoughts and behaviors.

Overall, both Alcohol CBM and PTSD CBM treatments are reported as safe options for individuals dealing with these conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Training for PTSD and alcoholism because it uses Cognitive Bias Modification (CBM) to directly target the cognitive patterns contributing to these conditions. Unlike traditional therapies, which often focus on behavior and coping strategies, CBM aims to reshape automatic thought processes that exacerbate PTSD and alcohol use disorders. This approach could offer a faster and potentially more lasting impact by addressing the root cognitive biases. By combining CBM for both alcohol use and PTSD, the treatment might provide a more comprehensive solution, tackling both issues simultaneously and enhancing overall mental health.

What evidence suggests that this trial's treatments could be effective for PTSD and Alcohol Use Disorder?

Research has shown that Cognitive Bias Modification (CBM) can help treat Alcohol Use Disorder (AUD) by changing harmful thought patterns. Studies have found that cognitive-behavioral methods reduce alcohol consumption and improve coping skills. For Posttraumatic Stress Disorder (PTSD), cognitive-behavioral therapy (CBT) effectively reduces symptoms and often compares well with other treatments. In this trial, participants may receive a combination of Alcohol CBM and PTSD CBM, aiming to further lessen symptoms of both conditions. These methods address the thought processes that contribute to both PTSD and AUD. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol CBM
• Alcohol Sham
• PTSD CBM
• PTSD Sham

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6561400/

Behavioral Treatments for Alcohol Use Disorder and Post ... Behavioral interventions for AUD include providing psychoeducation on addiction, teaching healthy coping skills, improving interpersonal functioning, bolstering ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00760994

Reducing Alcohol Use & Post-traumatic Stress Disorder ... The purpose of this study is to determine whether an experiential acceptance therapy intervention is effective in the treatment of alcohol dependency and post- ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25328957/

Randomized controlled trial of cognitive behaviour therapy ... This study aimed to test the efficacy of integrated cognitive behaviour therapy (CBT) for coexisting post traumatic stress disorder (PTSD) and alcohol use ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625002091

Cognitive-behavioral interventions for co-occurring ... The current meta-analysis provides an overview of cognitive-behaviorally-based interventions (CBI) that treat co-occurring alcohol and other drug use (AOD)

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836411

Concurrent Treatment of PTSD and Alcohol Use Disorder ... This trial indicates that integrated treatment for comorbid PTSD and SUD significantly reduces PTSD symptom severity in women with PTSD and AUD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5803416/

Development of a Novel, Integrated Cognitive-Behavioral ... In addition, preliminary studies indicate that CPT for PTSD is similarly well-tolerated by individuals with co-occurring PTSD and alcohol use disorder [20, 21], ...