- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07339917
Investigating Predictors of Outcomes From LENS
Investigating Predictors of Outcomes From LENS, a Cognitive Bias Modification for Interpretation (CBM-I) Training, in Adults With Elevated Anxiety
Anxiety is a very common mental health problem. For people living with anxiety, it can have a huge impact on their lives. There are treatments that can help, such as Cognitive Behavioural Therapy (CBT). However, about half of the people who receive treatment still struggle with anxiety after treatment is complete, and we do not yet know why. In this study, we hope to find factors that help explain why people respond differently to anxiety treatment. To answer this question, people in this study will receive a digital anxiety treatment called Learning Effective New Strategies (LENS). LENS is a type of brain training that helps people make less negative interpretations of uncertain situations and information. LENS has been proven to help reduce worry and anxiety, and improve mood (Hirsch et al., 2021). After participants finish LENS, we will measure how their patterns of thinking and mood changes over treatment and during the following five months. We will invite people to take part through multiple existing research studies (e.g. GLAD, TEDS) who have already shared their genetic data (information about their DNA). This way of recruiting would allow us to combine this genetic data with information from questionnaires to look for genetic and psychological factors that are linked with how well someone's anxiety improves after treatment. This research could help us understand what factors are linked to a person's outcomes from treatment. In the future, this could help health professionals personalise anxiety treatment and offer the right treatment to people sooner. This would mean that fewer people need to try multiple treatments before finding one that works. We hope this study will improve care for people living with anxiety.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Colette R Hirsch
- Phone Number: +44 (0) 20 7848 0697
- Email: colette.hirsch@kcl.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Participants who have taken part in previous genetic cohort studies, namely GLAD, TEDS and Genes & Health, will be invited to participate in the study.
Description
Inclusion Criteria:
- Adults over the age of 18
- Fluent in English
- Normal or corrected to normal hearing
- Normal or corrected to normal vision
- Currently experiencing anxiety (GAD-7 score ≥ 8)
- Access to stable internet connection
- Access to smartphone, laptop, computer, or tablet
Exclusion Criteria:
- Current high levels of suicidal ideation, as defined by a score ≥ 2 on Item 9 of the PHQ-9 OR score of 1 on Item 9 of the PHQ-9 and score ≥21 on the SIDAS
- Suicide attempt in past two years.
- Current or history of psychosis or bipolar disorder.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General Anxiety Disorder-7 score
Time Frame: 8 week follow up
|
General Anxiety Disorder-7 score on GAD-7 questionnaire |
8 week follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Colette R Hirsch, King's College London
- Principal Investigator: Thalia Eley, King's College London
- Principal Investigator: Gerome Breen, King's College London
- Principal Investigator: Ewan Carr, King's College London
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 363721
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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