Self-Guided Cognitive Behavioral Therapy for Alcohol Consumption and Suicidal Ideation

Overseen By Healthier Futures Lab

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mark J Rzeszutek, PhD

Disqualifiers: Schizophrenia, Other psychiatric, Substance use, others

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

Compensation: Varies

Number of Visits: 7

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the connections between alcohol use, suicidal thoughts, and decision-making, and to evaluate the effectiveness of a self-guided therapy, specifically Self-Guided Cognitive Behavioral Therapy. Participants will use a computer-based program to manage their drinking habits and monitor its impact on their thoughts and decisions. The trial seeks individuals who drink alcohol at least weekly, score high on the Alcohol Use Disorder Identification Test, and wish to reduce or quit drinking. As an unphased trial, this study provides a unique opportunity to contribute to the understanding and improvement of self-guided therapies for 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. However, it excludes those with certain psychiatric diagnoses other than depression or anxiety, and those already in treatment for alcohol use disorder.

What prior data suggests that this self-guided cognitive behavioral therapy is safe for alcohol use?

Research has shown that self-guided cognitive behavioral therapy (CBT) is safe and well-tolerated for reducing alcohol use and suicidal thoughts. Studies have found that individuals using computer-based CBT reported a decrease in the severity of their substance use problems over time. One study found that this therapy significantly reduced both alcohol use and suicidal thoughts.

Delivered online, the therapy can be done at home, offering convenience and minimal disruption. This approach also has fewer side effects compared to medications, as it focuses on changing thought patterns and behaviors rather than affecting body chemistry. Overall, self-guided CBT is considered a safe option for addressing alcohol use and related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for alcohol consumption and suicidal ideation, which often involve in-person therapy sessions or medication, the self-guided Cognitive Behavioral Therapy (CBT) being tested is delivered through a computer-based training program. This method allows participants to access therapy at their own pace and convenience, reducing barriers like scheduling conflicts and the stigma associated with seeking help. Researchers are excited about this treatment because it can potentially expand the reach of effective therapy to more people, especially those who might not have access to or feel comfortable with traditional therapy settings.

What evidence suggests that self-guided cognitive behavioral therapy is effective for alcohol use and suicidal ideation?

Research has shown that a self-guided program called CBT4CBT, a type of Cognitive Behavioral Therapy (CBT), effectively helps people reduce their alcohol use. Studies found that individuals using CBT4CBT reduced substance use more than those receiving standard treatment. More than eight clinical trials have demonstrated its effectiveness in lowering drug or alcohol consumption. Participants in this trial will have access to CBT4CBT, which aids in developing skills necessary for making positive changes, useful in managing alcohol use. While research on its ability to reduce suicidal thoughts is still developing, it has shown promise in improving overall mental health. ^{1 2 6 7 8}

Who Is on the Research Team?

Mark J Rzeszutek, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults over 21 who regularly consume alcohol and may have suicidal thoughts or behaviors, as well as depression. Participants should be interested in trying self-guided cognitive behavioral therapy to address these issues.

Inclusion Criteria

Consume alcohol at least weekly

A score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)

Some interest in cutting back on drinking or quitting

Exclusion Criteria

A score of 23 or greater on the Alcohol Withdrawal System Checklist (AWSC)

Already being in treatment for alcohol use disorder at baseline

I have been diagnosed with a psychiatric condition other than depression or anxiety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment and are given access to remote, self-guided CBT4CBT modules for alcohol use

1 week

1 visit (remote)

Remote Intervention

Participants engage with remote, self-guided CBT4CBT modules for alcohol use

12 weeks

3 follow-up assessments (remote)

Follow-up

Participants are monitored for changes in alcohol use and suicidal thoughts and behaviors

3 months

3 visits (remote)

What Are the Treatments Tested in This Trial?

Interventions

• Self-Guided Cognitive Behavioral Therapy

Trial Overview The study tests if a computer-based training program for cognitive behavioral therapy (CBT4CBT) can help reduce alcohol use and improve decision-making among those with suicidal tendencies. It involves baseline assessment, access to CBT modules, and follow-ups over three months.

How Is the Trial Designed?

Group I: Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Participants in this arm will complete four assessments, one at baseline, then another three one month apart. Participants will be given access to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) at the end of their baseline session.

Who Is Running the Clinical Trial?

Mark J Rzeszutek, PhD

Lead Sponsor

Trials

1

Recruited

100+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A scoping review identified 12 unique group therapies targeting suicidal thoughts and behaviors, showing that all reported reductions in suicide-related outcomes, although most studies lacked sufficient power to confirm effectiveness.

The findings suggest that suicide-focused group therapies are generally feasible and acceptable, highlighting the need for more rigorous randomized controlled trials to better assess their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide-Focused Group Therapy. Chalker, SA., Martinez Ceren, CS., Ehret, BC., et al.[2022]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

In a study of 260 chronically depressed patients, those receiving Cognitive Behavioral Analysis System of Psychotherapy (CBASP) reported more severe adverse events compared to those receiving supportive psychotherapy, particularly in personal and occupational life.

However, CBASP was associated with fewer adverse events related to suicidal thoughts, suggesting that while it may lead to some temporary challenges, it can be a safer option in terms of suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. Meister, R., Lanio, J., Fangmeier, T., et al.[2021]

Cognitive behavior therapy (CBT) and problem-solving therapy (PST) both led to significant improvements in various measures related to hopelessness and suicidal ideation among suicide attempters, indicating their efficacy as treatment options.

Participants receiving CBT and PST reported higher satisfaction levels compared to those receiving treatment as usual (TAU), highlighting the potential benefits of these brief therapies in managing suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. Stewart, CD., Quinn, A., Plever, S., et al.[2018]

Internet-based cognitive behavioral therapy (iCBT) has been found to significantly reduce suicidal ideation among individuals, based on a review of four studies involving 1225 participants.

While iCBT shows promise in addressing suicidal thoughts, there is currently insufficient evidence to confirm its effectiveness in reducing actual suicide attempts or deaths, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based cognitive behavioral therapy for suicide: a systematic review and meta-analysis of RCTs. Yu, T., Hu, D., Teng, F., et al.[2022]

Cognitive-behavioral therapy (CBT) is recognized as an effective treatment for depression in children and adolescents, but there is limited evidence specifically addressing its efficacy for adolescents experiencing suicidality.

The article discusses various CBT techniques aimed at reducing suicidal thoughts and behaviors in depressed adolescents, highlighting the need for more targeted treatment trials in this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for adolescent depression and suicidality. Spirito, A., Esposito-Smythers, C., Wolff, J., et al.[2022]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

In a study involving 418 adults with suicidal ideation, the internet-based cognitive behavioral therapy (CBT) intervention 'Living with Deadly Thoughts' showed a lower rate of reliable deterioration (7%) compared to an attention control group (14%), indicating it is a safer option for suicide prevention.

The analysis found that initial severity of suicidal thinking was linked to lower odds of deterioration, while other psychological and demographic factors did not significantly affect deterioration rates, reinforcing the safety of internet-based CBT interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates and Predictors of Deterioration in a Trial of Internet-Delivered Cognitive Behavioral Therapy for Reducing Suicidal Thoughts. Batterham, PJ., Christensen, H., Calear, AL., et al.[2022]

Citations

1. withpower.com withpower.com/trial/self-guided-cognitive-behavioral-therapy-for-alcohol-consumption-and-suicidal-ideation-83e36

Self-Guided Cognitive Behavioral Therapy for Alcohol ... What data supports the effectiveness of the treatment Self-Guided Cognitive Behavioral Therapy for reducing alcohol consumption and suicidal ideation? Research ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12276506/

Computer-based training for cognitive behavioral therapy ... The results suggest that CBT4CBT is linked with a reduction in SUD symptoms and an increase in CBT skills, including change strategies and ...

3. cbt4cbt.com cbt4cbt.com/

Computer Based Training for Cognitive Behavioral Therapy ... Over 8 clinical trials show: CBT4CBT is more effective in reducing drug or alcohol use than standard substance use treatment. CBT ...

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2018.17090978

Randomized Clinical Trial of Computerized and Clinician ... The primary outcome measure was change in self-reported frequency of substance use (operationalized as frequency of any drug or alcohol use, by ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02742246?term=cbt4cbt&aggFilters=status:&viewType=Table&rank=8

Efficacy and Mechanisms of CBT4CBT for Alcohol Use ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07021053

Adaptive Actions and Alcohol Use Outcomes During ... This observational study investigates an Internet-delivered Cognitive Behaviour Therapy (ICBT) intervention for alcohol misuse, called the Alcohol Change ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2214782921001305

Alcohol and drug use among clients receiving internet ... Research shows that alcohol and drug use among mental health clients is common and has the potential to negatively impact treatment outcomes.

8. mental.jmir.org mental.jmir.org/2024/1/e50399

Feasibility, Acceptability, and Potential Efficacy of a Self ... The intervention produced significant reductions in suicidal ideation, alcohol consumption, and emotion dysregulation. Although the treatment ...