Recruiting

Observational Study

Sponsor:

Ohio University

Code:

NCT05172427

Conditions

Generalized Anxiety Disorder

Emotional Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

14 days of EMI

Uncertainty reappraisal training

Study Details

Brief summary:

Anxiety disorders are prominent mental health burdens, affecting roughly 1 in 5 adults annually, and a third of individuals over the course of their life. These disorders are also impairing to individuals, with 23% of individuals with anxiety disorders describing their impairment as serious. Given the public health impact, it is crucial that interventions are designed to alleviate symptoms of anxiety, through reducing risk factors that predispose individuals to develop anxiety. One approach to do this is to develop brief interventions that could be administered virtually, which can then be supplemented using ecological momentary intervention (EMI) to reduce risk factors for anxiety disorders. In contrast to targeting more distant risk factors, targeting more direct risk factors, such as intolerance of uncertainty, could be used in the prevention and treatment of anxiety disorders.

Conditions

Generalized Anxiety Disorder

Emotional Disorder

Study ID

NCT05172427

Start date

Sep 15, 2021

Status verified date

Dec, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Elevated GAD symptoms (i.e., GAD-7 scores greater than or equal to 10)
  • Elevated IU symptoms (i.e., IUS-12 scores greater than or equal to 28)
  • Access to a device with internet connection

Exclusion Criteria:

  • N/A

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CLUE intervention (EMA + EMI)

Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, they will have a meeting with a clinician and be given the CLUE intervention targeting intolerance of uncertainty. Following this intervention, participants will be given 14 days of EMA, which will include EMI prompts that they come up with at the end of the CLUE intervention (framed as "key takeaways"). After the two week period of EMA/EMI, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline, acceptability and feasibility of the intervention will be assessed at post-intervention. One month after post-intervention, participants will complete a one-month follow up questionnaire battery, that will again ask about acceptability and feasibility of the intervention, as well as parallel questions from baseline and post-intervention.

active comparator: CLUE intervention (EMA only)

Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, they will have a meeting with a clinician and be given the CLUE intervention targeting intolerance of uncertainty. Following this intervention, participants will be given 14 days of EMA. After the two week period of EMA, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline, acceptability and feasibility of the intervention will be assessed at post-intervention. One month after post-intervention, participants will complete a one-month follow up questionnaire battery, that will again ask about acceptability and feasibility of the intervention, as well as parallel questions from baseline and post-intervention.

no intervention: Waitlist control

Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, participants will be assigned 14 days of EMA. After the two week period of EMA, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline. One month after the post-intervention questionnaires, participants will complete a one-month follow up questionnaire battery, that will include parallel questions from baseline and post-intervention. As these participants did not receive the intervention following their baseline EMA, they will be given the opportunity to schedule an appointment for the intervention after they have completed their one-month follow up questionnaire.

Interventions

14 days of EMI

Following the intervention, participants will receive personalized prompts whenever they report elevated stress or anxiety. These prompts will be generated at the end of the intervention session, and will only be sent to individuals in the EMI condition.

Uncertainty reappraisal training

CLUE consists of an hour long intervention, followed by a 2-week long EMI. During the hour long intervention session, participants will receive psychoeducation (i.e., defining uncertainty), discuss myths associated with uncertainty (e.g., if I do not plan things, they will go poorly), and discuss behavioral experiments that can be done to challenge uncertainty beliefs.

Primary outcome measure

  • Client Satisfaction Questionnaire-8 [ Time Frame: One day after 14-day EMA/EMI ]
  • Client Satisfaction Questionnaire-8 [ Time Frame: One month follow up ]
  • Feasibility of service [ Time Frame: 14-day EMA/EMI ]

Central Contacts and Locations

Central contacts

Nicholas Allan, Ph.D.

740-597-2717allan@ohio.edu

Brandon Koscinski, M.A.

315-316-7248bk675018@ohio.edu

Locations

Ohio University

Recruiting

Athens, Ohio, United States, 45701

More Information

Sponsor

Ohio University

Last update posted

Dec 29, 2021

Last verified

Dec, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio University on 2021-12-29.