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

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.

What data supports the effectiveness of the treatment Maintaining a healthy lifestyle single session intervention, Uncertainty-focused single session intervention for anxiety?

Research shows that treatments focusing on reducing intolerance of uncertainty can be effective for generalized anxiety disorder (GAD). In one study, a cognitive-behavioral treatment that helped patients become more tolerant of uncertainty led to significant improvements, with most participants no longer meeting the criteria for GAD after treatment. ^{1 2 3 4 5}

Is the Uncertainty Intervention for Anxiety safe for humans?

The research articles provided do not contain specific safety data for the Uncertainty Intervention for Anxiety or its related interventions. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How does the Uncertainty Intervention for Anxiety treatment differ from other treatments for anxiety?

This treatment is unique because it combines a single session intervention focused on maintaining a healthy lifestyle with an uncertainty-focused approach, which is not commonly used in standard anxiety treatments. It emphasizes self-management and personalized lifestyle changes, which are designed to enhance general well-being and address psychological distress. ^{11 12 13 14 15}

What is the purpose of this trial?

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 responses to ambiguous choices.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial. [2023]

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

An Exploration of Intervention Augmentation in a Single Case. [2023]

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

Treatment of GAD. Targeting intolerance of uncertainty in two types of worry. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Home-based COPD psychoeducation: A qualitative study of the patients' experiences. [2018]

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

How to customize a bona fide psychotherapy for generalized anxiety disorder? A two-arms, patient blinded, ABAB crossed-therapist randomized clinical implementation trial design [IMPLEMENT 2.0]. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Health anxiety disorders: a cognitive construal. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Towards a model of uncertainty distress in the context of Coronavirus (COVID-19). [2023]

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

A little uncertainty goes a long way: state and trait differences in uncertainty interact to increase information seeking but also increase worry. [2009]

10. England pubmed.ncbi.nlm.nih.gov

Anxiety disorders: why they persist and how to treat them. [2019]

11. England pubmed.ncbi.nlm.nih.gov

The effectiveness and applicability of different lifestyle interventions for enhancing wellbeing: the study design for a randomized controlled trial for persons with metabolic syndrome risk factors and psychological distress. [2021]

12. England pubmed.ncbi.nlm.nih.gov

My Healthy Brain: a multimodal lifestyle program to promote brain health. [2022]

13. England pubmed.ncbi.nlm.nih.gov

HEAD-MIP-(HEAlth Dialogues for patients with Mental Illness in Primary care)-a feasibility study. [2023]

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

Rationale and protocol for a pilot randomized controlled trial of a cognitive prescription intervention for reducing dementia risk factors among African Americans. [2023]

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

The effects of group counseling based on the solution-focused approach on anxiety and healthy lifestyle behaviors in individuals with eating disorders. [2022]