Stress and Anxiety for Adjustment Disorder

AW
CR
Overseen ByCandace Raio, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stress and anxiety influence decision-making and adaptation to new situations. Researchers use tasks like the Socially Evaluated Cold Pressor Task (SECPT) to observe changes in decision-making processes under stress. The trial suits individuals who speak English fluently and have experienced anxiety or have a diagnosis of generalized anxiety disorder (GAD). Participants should not have high blood pressure, heart conditions, or certain other medical conditions. As an unphased study, this trial provides a unique opportunity to contribute to understanding anxiety's impact on decision-making.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of psychiatric medication for at least 4 weeks before participating. If you are taking corticosteroids or beta-blockers, you will need to stop taking them to join the study.

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

Research has shown that the Socially Evaluated Cold Pressor Task (SECPT), a method used to induce stress, is generally safe for participants. Studies have found that it reliably triggers the body's stress responses, such as slight increases in blood pressure, heart rate, and cortisol levels, a stress hormone. These changes are normal reactions to stress and are usually not harmful to healthy individuals. However, factors like gender, genetics, and smoking can influence stress responses.

No strong evidence of serious side effects exists, indicating that most people handle the SECPT well. However, those with specific health concerns should consult a healthcare provider before participating.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different tasks impact stress and anxiety levels in individuals with adjustment disorder. Unlike traditional treatments like therapy and medication, this trial examines the body's neuroendocrine response, specifically cortisol, to stress tasks like the Socially Evaluated Cold Pressor Task (SECPT). The goal is to understand how various stress and non-stress tasks affect value adaptation and emotional responses, which could lead to new insights into managing anxiety and stress. By focusing on the biological responses to these tasks, the trial could pave the way for more personalized and effective treatment strategies.

What evidence suggests that this trial's treatments could be effective for stress and anxiety?

Research has shown that the Socially Evaluated Cold Pressor Task (SECPT), which participants in this trial may undergo, effectively causes stress by activating the body's stress system, the HPA axis. Studies have found that this stress response can impact decision-making and learning, potentially helping researchers understand anxiety better. The SECPT combines social and physical stress to influence trust and social behaviors. In past studies, the SECPT significantly increased stress levels and altered responses to rewards and habits. This suggests that the SECPT could be a useful tool for studying stress and anxiety in individuals with adjustment disorders. Meanwhile, participants in other trial arms will complete a non-stressful control task, allowing researchers to compare the effects of stress versus non-stressful conditions.12678

Who Is on the Research Team?

CR

Candace Raio, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals experiencing adjustment disorder, which can occur after a stressful life event. Participants should be interested in how stress and anxiety affect their decision-making processes. Specific eligibility criteria are not provided, but typically participants would need to meet certain health and demographic requirements.

Inclusion Criteria

Aims 1-3: Able to speak, read, and write fluently in English
Aim 4: Able to speak, read, and write fluently in English
Aims 1-3: Be willing and able to follow study procedures and provide informed consent
See 4 more

Exclusion Criteria

Aims 1-3: Diabetes, food allergies, metabolic disorders or history of eating disorder
Aim 4: Diabetes, food allergies, metabolic disorders or history of eating disorder
Aim 4: Lifetime history of bipolar disorder or any psychotic disorder; substance use disorder in past 3 months; eating disorder in past 6 months; current major depressive disorder (past is allowed)
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Study Visit

Participants complete demographic and self-report measures, followed by random assignment to complete either the Socially Evaluated Cold Pressor Task (SECPT) or a non-stressful control task. Cortisol samples are collected throughout the session.

1 day (Approx. 2 hours)
1 visit (in-person)

Behavioral Task

Participants complete various tasks such as the Food Value Adaptation Task, Image Value Adaptation Task, and Affective Prediction Error Task to assess decision-making variables.

1 day (Approx. 2 hours)
1 visit (in-person)

Follow-up

Participants are monitored for any changes in stress and anxiety levels post-study visit.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Non-Stressful Control Task
  • Socially Evaluated Cold Pressor Task (SECPT)
Trial Overview The study is testing the effects of a Socially Evaluated Cold Pressor Task (SECPT), which induces stress, against a Non-Stressful Control Task on learning and decision-making. It aims to understand changes in value adaptation and affective prediction errors under stress and anxiety.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Active Control
Group I: Aim 3: Socially Evaluated Cold Pressor Task (SECPT)Experimental Treatment1 Intervention
Group II: Aim 2: Socially Evaluated Cold Pressor Task (SECPT)Experimental Treatment1 Intervention
Group III: Aim 1: Socially Evaluated Cold Pressor Task (SECPT)Experimental Treatment1 Intervention
Group IV: Aim 1: Non-Stressful Control TaskActive Control1 Intervention
Group V: Aim 3: Non-Stressful Control TaskActive Control1 Intervention
Group VI: Aim 2: Non-Stressful Control TaskActive Control1 Intervention
Group VII: Aim 4:Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

Evaluation of the socially evaluated cold-pressor group test ...Our study confirms that the SECPT-G is a stress induction tool which elicits a strong HPA axis response, which is mostly independent of many ...
Acute social and physical stress interact to influence social ...Our results show that social and physical stress interacted to modulate trust, trustworthiness, and sharing.
Socially evaluated cold pressor stress after instrumental ...Cortisol responses to stress correlated significantly with habitual performance. These findings show that stress induced by the socially ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/29573884/
Ten years of research with the Socially Evaluated Cold ...Our analyses show that the SECPT leads, both in men and women, to striking increases in subjective stress levels, autonomic arousal, and cortisol, albeit the ...
Effects of Focusing and Distraction on Cold Pressor ...Focused attention was associated with higher pain and lower completion rates in chronic pain patients compared with healthy control subjects.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/24845183/
The socially evaluated cold-pressor test (SECPT) for groupsOur results indicate that the group SECPT activates the SNS and the HPA, leading to increased blood pressure, heart rate, and cortisol concentration.
HPA axis activation by a socially evaluated cold-pressor testWe used the Socially Evaluated Cold Pressor Test (SECPT) to induce stress, as this task reliably induces SAM and HPA axis activation (Schenk et ...
The socially evaluated cold-pressor test (SECPT) for groupsThe results suggest that gender, genetics and nicotine consumption can influence the individual's stress responsiveness to psychological stress while ...
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