Uncertainty Intervention for Anxiety

Overseen By Brent I Rappaport, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Psychosis, Autism, Neurological condition, others

Compensation: Varies

Number of Visits: 2

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a single session can alter reactions to uncertainty and ambiguity. It focuses on whether this intervention affects decision-making and brain responses in unclear situations. Participants will engage in one of two digital, self-guided sessions: one teaches strategies for managing uncertainty (uncertainty-focused single session intervention), while the other emphasizes maintaining a healthy lifestyle (maintaining a healthy lifestyle single session intervention). Individuals who frequently struggle with uncertainty and can read and write in English may be well-suited for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance coping strategies for uncertainty.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that single-session treatments focused on dealing with uncertainty are generally easy for people to handle. Studies have found that these treatments can lower emotional distress without causing major side effects. For example, one study found that participants did not report any serious negative reactions after completing the treatment. Additionally, similar single-session treatments have helped people feel better and more open to change. This suggests that the approach is safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for anxiety that often involve medication or extensive therapy sessions, the uncertainty-focused single session intervention (SSI) is a digital, self-guided program that emphasizes embracing uncertainty. This approach leverages concepts like neuroplasticity to help individuals reshape their thoughts and behaviors, making it a novel psychological tool. Researchers are particularly excited because this intervention is concise, potentially offering rapid improvements in anxiety management without the need for prolonged therapy or medication, which could increase accessibility and reduce costs for patients.

What evidence suggests that this trial's interventions could be effective for anxiety?

Research has shown that single session interventions (SSIs) focused on dealing with uncertainty can help reduce anxiety. In this trial, participants may receive the Uncertainty-focused single session intervention, which teaches ways to better cope with uncertainty using concepts like the brain's ability to change and techniques that adjust thinking and behavior. One study found that about 58.3% of participants improved in managing uncertainty, increasing to 66% after three months. Although more research is needed, these interventions appear promising in helping people feel more at ease with uncertainty, potentially lowering anxiety symptoms. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 25 to 60 who are right-handed, can read and write English, and have a discomfort with uncertainty. They must be able to consent and not have an IQ below 80 or significant neurological issues, pregnancy, electrical implants in the body, or a history of severe mental health conditions like psychosis or autism.

Inclusion Criteria

Right-handed

Ability to read and write English

Intolerance of uncertainty score ≥ -0.5 standard deviation below the mean (31st percentile)

Exclusion Criteria

Personal history of psychosis, mania, or hypomania

Personal history of autism spectrum disorder

IQ < 80 as determined by the Wechsler Test of Adult Reading

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants undergo a single session intervention to test changes in ambiguity aversion

1 day

1 visit (in-person)

Assessment

Participants complete decision making tasks and questionnaires before and after the intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in ambiguity aversion and hopelessness

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maintaining a healthy lifestyle single session intervention
• Uncertainty-focused single session intervention

Trial Overview

The study examines how a single session intervention focused on dealing with uncertainty affects decision-making and brain responses when facing ambiguous choices. It compares this approach with another session promoting general healthy lifestyle habits.

How Is the Trial Designed?

Group I: Uncertainty-focused single session intervention Experimental Treatment 1 Intervention

This is a digital, self-guided SSI that teaches adults about tolerating and embracing uncertainty in their life. The SSI is based on five elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from peers describing beliefs that people's thoughts, feelings, and behaviors are malleable, given the brain's capacity for change; 3. Strategies (from cognitive-behavioral therapy) for applying these principles to participants' lives; 4. Further vignettes by peers describing times when they tolerated or embraced uncertainty; 5. An exercise wherein participants provide advice to fictional peers, using newly-gleaned information about uncertainty,

Group II: Maintaining a healthy lifestyle single session intervention Placebo Group 1 Intervention

This is a digital, self-guided SSI that teaches adults about the benefits of maintaining a healthy lifestyle (e.g., proper sleep, diet, exercise), emphasizing recommendations by various bodies (e.g., American Medical Association). It is structurally similar to the uncertainty-focused SSI but is designed to mimic what people would receive in their annual physical with a primary care physician. The goals of this intervention is to encourage participants to identify aspects of a healthy lifestyle, and steps they could take towards a healthier lifestyle. This SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program, reading and writing exercises, and vignettes from peers.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study tested a brief, 5-session transdiagnostic treatment for anxiety disorders called F-SET, which significantly reduced anxiety (Cohen's d=2.01) and depression (Cohen's d=2.16) in 28 participants compared to a waitlist control group.

The effectiveness of F-SET was linked to a reduction in avoidance strategies, suggesting that targeting these behaviors can be a key mechanism for improving anxiety symptoms, making it a potentially low-cost and efficient therapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. Riccardi, CJ., Korte, KJ., Schmidt, NB.[2022]

The My Healthy Brain (MHB) program, tested on 24 older adults with cognitive decline, showed good feasibility and acceptability, with 100% participant satisfaction and no reported adverse events.

Participants demonstrated improvements in lifestyle behaviors and subjective well-being after the 8-week program, indicating MHB's potential effectiveness in promoting healthier lifestyles to combat cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

My Healthy Brain: a multimodal lifestyle program to promote brain health. Mace, RA., Greenberg, J., Stauder, M., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10131727/

Examination of Web-Based Single-Session Growth ...

This study aims to compare the effectiveness of three SSIs: single-session intervention of growth mindset on negative emotions (SIGMA), SSI of growth mindset ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1077722919300690

Intolerance of Uncertainty–Focused Treatment for ...

Based on a clinician rating, 58.3% were categorized as much or very much improved at posttreatment, rising to 66% at 3-month follow-up. Participants with ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06962527

Test of Target Engagement of Ambiguity Aversion

The present work aims to test whether a single session intervention alters ambiguity aversion, both in terms of people's decision making and their brain ...

4.

bmcpsychology.biomedcentral.com

bmcpsychology.biomedcentral.com/articles/10.1186/s40359-023-01410-0

Effectiveness of single-session therapy for adult common ...

(2021) reported that SST is more effective than no treatment for reducing anxiety in youth and adults [26]. However, most of the included ...

5.

mentalhealth.bmj.com

mentalhealth.bmj.com/content/28/1/e301416

Single-session intervention with and without video support ...

This study compared a single-session intervention (SSI) with an enhanced version incorporating weekly personalised prerecorded videos for 4 weeks.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11977485/

a randomised clinical trial - PMC - PubMed Central

To evaluate the efficacy of a single-session intervention (SSI), with and without weekly personalised prerecorded videos, in preventing emotional distress ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0149763425001381

Psychological mechanisms underpinning change in ...

All three studies found that the intervention reduced interpretation bias scores from pre to post test (1 week or 4 weeks) (Li et al., 2021, Oglesby et al., ...

8.

researchgate.net

researchgate.net/publication/334390282_Intolerance_of_Uncertainty-Focused_Treatment_for_Adolescents_With_Excessive_Worry_A_Pilot_Feasibility_Study

(PDF) Intolerance of Uncertainty–Focused Treatment for ...

Based on a clinician rating, 58.3% were categorized as much or very much improved at posttreatment, rising to 66% at 3-month follow-up.

9.

ueaeprints.uea.ac.uk

ueaeprints.uea.ac.uk/97544/1/2024BallJClinPsyD_Thesis.pdf

Exploring the Efficacy of Brief, Single-Session Interventions to ...

The aim of this study was to systematically review and synthesise evidence of the efficacy of self-administered SSIs on mental health outcomes in young people.