What side effects are associated with this type of intervention?

The most common treatments for Generalized Anxiety Disorder (GAD) include selective serotonin reuptake inhibitors (SSRIs) like sertraline and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine. Common side effects of SSRIs and SNRIs include nausea, headache, sleep disturbances, sexual dysfunction, and increased anxiety initially. Cognitive-behavioral therapy (CBT) is another effective treatment, with potential side effects being temporary increases in anxiety when confronting feared situations. The Augmented Training Condition (ATC) in the RCMP Study likely includes elements of CBT to mitigate PTSI, which aligns with the non-pharmacological approach to treating GAD.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Generalized Anxiety Disorder (GAD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Commonly approved SSRIs include sertraline, paroxetine, and escitalopram, while SNRIs such as venlafaxine and duloxetine are also frequently used. These medications are preferred due to their efficacy in reducing anxiety symptoms and their relatively favorable side effect profiles compared to other options like benzodiazepines or tricyclic antidepressants (TCAs). The Augmented Training Condition (ATC) in the RCMP study aims to enhance resilience and mitigate PTSI, which aligns with the use of SSRIs and SNRIs in managing anxiety and stress-related disorders.

What other types of research exist?

Promising, novel alternatives for treating Generalized Anxiety Disorder (GAD) in 2024 include: 1) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in psychosocial functioning and could benefit GAD patients with sleep disturbances. 2) Controlled Rhythmic Yogic Breathing, which has been effective in reducing PTSD symptoms and may help alleviate anxiety. 3) Service Dog Programs, which have shown preliminary efficacy in reducing PTSD symptoms and could provide emotional support and anxiety reduction for GAD patients.

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Emotional Resilience Training for PTSD

N/A

Recruiting

Led By R. Nicholas Carleton, PhD

Research Sponsored by University of Regina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time 2 (post-training; week 26), time 3 (1-year follow-up), time 4 (2-year follow-up), time 5 (3-year follow-up), time 6 (4-year follow-up), time 7 (5-year follow-up)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the mental health of RCMP cadets by providing enhanced training that includes skills to manage stress and trauma. The goal is to reduce posttraumatic stress injuries among cadets.

Who is the study for?

This trial is specifically for cadets beginning the RCMP Cadet Training Program. It aims to study mental health risk and resilience factors related to traumatic stress. Only these cadets can participate, excluding anyone else not starting this program.

What is being tested?

The trial tests Emotional Resilience Skills Training (ERST) against Active Monitoring in new RCMP cadets. They'll be assessed before and after training, then annually for five years, plus with monthly and daily surveys to measure mental health outcomes.

What are the potential side effects?

Since the interventions involve skills training and monitoring rather than medical treatments, traditional side effects are not expected; however, participants may experience emotional discomfort or stress during the process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time 2 (post-training; week 26), time 3 (1-year follow-up), time 4 (2-year follow-up), time 5 (3-year follow-up), time 6 (4-year follow-up), time 7 (5-year follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time 2 (post-training; week 26), time 3 (1-year follow-up), time 4 (2-year follow-up), time 5 (3-year follow-up), time 6 (4-year follow-up), time 7 (5-year follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time 2 (post-training; week 26), time 3 (1-year follow-up), time 4 (2-year follow-up), time 5 (3-year follow-up), time 6 (4-year follow-up), time 7 (5-year follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)

Unipolar Depression

Panic Disorder

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Augmented Training Condition (ATC)Experimental Treatment1 Intervention

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based cognitive-behavioral intervention designed to cultivate constructive approach-oriented emotional engagement. The 13-week Emotional Resilience Training (ERST) is an adaptation of the UP designed for use as a proactive training course. The ERST frames emotional experiences as natural responses to threat, rather than pathological occurrences to avoid; as such, the ERST is well-suited for mitigating health challenges and the skills may also help PSP to support persons in distress, including other PSP and the community members they all serve. The ERST training materials include an instructor guide, didactic PowerPoints, and a trainee workbook. The ERST was designed for seamless integration with the Cadet Training Program, effective June 2022, which is what creates the augmented training arm (i.e., the ATC).

Group II: Standard Training Condition (STC)Active Control1 Intervention

The STC has received the "standard" RCMP Depot Division ("Depot") Cadet Training Program as has been provided to cadets prior to June 2022. The STC and the ATC will complete the same standardized self-report assessments, clinical interview assessments, and biometric assessments, and receive the same feedback and reporting based on those assessments.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Generalized Anxiety Disorder (GAD) include pharmacological and psychotherapeutic approaches. SSRIs and SNRIs increase serotonin and norepinephrine levels in the brain, helping to regulate mood and reduce anxiety. Buspirone acts as a partial agonist at serotonin receptors, alleviating anxiety symptoms. Cognitive Behavioral Therapy (CBT) involves cognitive restructuring and behavioral interventions to change negative thought patterns and behaviors. These treatments are crucial for GAD patients as they address the neurochemical and cognitive processes underlying anxiety, offering both immediate and sustained relief.

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