An observational study of the effect of serotonin re-uptake inhibitors (SSRIs) on both the communication between brain and body and symptoms of anxiety

Not Applicable

Recruiting

• Conditions: Anxiety; Mental Health - Anxiety

• Registration Number: ACTRN12620000952943
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-24
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Both groups:
Diagnosed with any clinically significant anxiety disorder AND prescribed with a course of an SSRI by their medical practitioner
Male or female aged between 18 and 45 years
Ability to provide written and informed consent
Ability to adhere to the study protocol
Exposure group only: Either have not started or be within the first 7 days of beginning their SSRI medication
Control group only: Have been taking their SSRI medication consistently for at least 3 months

Exclusion Criteria

Evidence of severe acute or chronic medical disorders, including a neurological disorder, current or past history of a severe brain injury or severe respiratory disorder e.g. severe asthma, chronic obstructive pulmonary disease etc.
Past or current diagnoses of schizophrenia, bipolar disorder, drug addiction or psychosis
Colour blindness
Female patients who are pregnant or breastfeeding
Current significant suicidal ideation
Participants must be free of recreational drug and alcohol use at the time of testing

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in self-reported anxiety measured using a combination of the Spielberger Trait Anxiety Score, GAD-7 (Generalised Anxiety Disorder Questionnaire) and ASI-3 (Anxiety Sensitivity Index-3) compared to changes in the control group[ Within one week (or prior) and at least 6 weeks post commencement of intervention];Change in breathing perception and related metacognition, measured using a behavioural breathing task (the Filter Detection Task) compared to changes in the control group[ Within one week (or prior) and at least 6 weeks post commencement of intervention];Change in interoceptive learning related to breathing, measured using a behavioural breathing task (the Breathing Learning Task) compared to changes in the control group[ Within one week (or prior) and at least 6 weeks post commencement of intervention]