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CLUE intervention (EMA + EMI) for Generalized Anxiety Disorder (CLUE Trial)

N/A

Waitlist Available

Research Sponsored by Ohio University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month follow up

Awards & highlights

CLUE Trial Summary

This trial is testing whether two different types of interventions can help reduce symptoms of anxiety in adults.

Eligible Conditions

Generalized Anxiety Disorder
Emotional Disorder

CLUE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Client Satisfaction Questionnaire-8

Feasibility of service

Secondary outcome measures

Alcohol Use Disorder Identification Test (AUDIT)

COVID-19 contraction questions

COVID-19 impact battery short-form (CIB-SF)

+15 more

CLUE Trial Design

3Treatment groups

Active Control

Group I: CLUE intervention (EMA + EMI)Active Control2 Interventions

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.

Group II: Waitlist controlActive Control1 Intervention

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.

Group III: CLUE intervention (EMA only)Active Control1 Intervention

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.

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Who is running the clinical trial?

Ohio UniversityLead Sponsor

69 Previous Clinical Trials

37,169 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently welcome to join this experiment?

"Affirmative. According to information provided on clinicaltrials.gov, the trial is currently enrolling patients and has been since its launch date of September 15th 2021. The last modification was made December 13th 2021 and 45 individuals are needed from a single site for participation in this medical study."

Answered by AI

What goals are investigators attempting to accomplish with this clinical trial?

"The primary aim of the survey, which will be measured over a one-month follow up period is to evaluate service feasibility. There are also three secondary objectives that include assessing Ruminative Response Scale (RRS), Intolerance of Uncertainty-12 (IU-12), and PROMIS Anxiety scale scores. The RRS comprises queries regarding responses to depressed mood, IU-12 evaluates an individual's aptitude for tolerating ambiguous situations, while the PROMIS Anxiety scale measures fear and somatic symptoms in greater detail."

Answered by AI

What is the current capacity for participants in this research trial?

"Affirmative. Clinicaltrials.gov verifies that the trial, which was initiated on September 15th 2021, is currently recruiting participants from a single site and needs 45 volunteers to complete it."

Answered by AI

Recent research and studies

PsychotherapyJournal

A Randomized Controlled Trial of Ecological Momentary Intervention Plus Brief Group Therapy for Generalized Anxiety Disorder.

Newman, Michelle G., Amy Przeworski, Andrés J. Consoli, and C. Barr Taylor. 2014. “A Randomized Controlled Trial of Ecological Momentary Intervention Plus Brief Group Therapy for Generalized Anxiety Disorder.”. Psychotherapy. American Psychological Association (APA). doi:10.1037/a0032519.

Journal of Anxiety DisordersJournal

Fear of the Unknown: One Fear to Rule Them All?

Carleton, R. Nicholas. 2016. “Fear of the Unknown: One Fear to Rule Them All?”. Journal of Anxiety Disorders. Elsevier BV. doi:10.1016/j.janxdis.2016.03.011.

Journal of Anxiety DisordersJournal

Intolerance of Uncertainty and DSM-5 PTSD Symptoms: Associations Among a Treatment Seeking Veteran Sample

Raines, Amanda M., Mary E. Oglesby, Jessica L. Walton, Gala True, and C. Laurel Franklin. 2019. “Intolerance of Uncertainty and DSM-5 PTSD Symptoms: Associations Among a Treatment Seeking Veteran Sample”. Journal of Anxiety Disorders. Elsevier BV. doi:10.1016/j.janxdis.2018.12.002.

Behaviour Research and TherapyJournal