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

Trial Summary

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

Research shows that cognitive behavioral therapy (CBT) can effectively reduce suicidal thoughts and behaviors, especially when it focuses directly on these issues. Additionally, internet-based CBT has been found to help reduce suicidal thoughts, making it a promising option for those who may not seek traditional face-to-face therapy. ^{1 2 3 4 5}

Is self-guided cognitive behavioral therapy generally safe for humans?

Research on cognitive behavioral therapy (CBT) suggests it is generally safe, with low rates of serious adverse events like suicide attempts or hospitalizations. However, temporary increases in anxiety or distress can occur, which are often considered a normal part of therapy. ^{4 6 7 8 9}

How is Self-Guided Cognitive Behavioral Therapy different from other treatments for alcohol consumption and suicidal ideation?

Self-Guided Cognitive Behavioral Therapy (CBT) is unique because it allows individuals to work through therapy techniques on their own, focusing specifically on reducing suicidal thoughts and behaviors, which has been shown to be effective. This approach is different from traditional therapy as it does not require a therapist's direct involvement, making it more accessible and flexible for individuals. ^{1 2 4 10 11}

What is the purpose of this trial?

The purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults. Participants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.

Research Team

Mark J Rzeszutek, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for suicidal behaviors: improving patient outcomes. [2022]

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

Protocol: Reducing suicidal ideation among Turkish migrants in the Netherlands and in the UK: effectiveness of an online intervention. [2022]

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

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. [2018]

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

Cognitive-behavioral therapy for adolescent depression and suicidality. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based cognitive behavioral therapy for suicide: a systematic review and meta-analysis of RCTs. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Rates and Predictors of Deterioration in a Trial of Internet-Delivered Cognitive Behavioral Therapy for Reducing Suicidal Thoughts. [2022]

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

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

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

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

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

Predictors of attempted suicide among Swiss patients with alcohol-use disorders. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Suicide-Focused Group Therapy. [2022]