- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07339917
Investigating Predictors of Outcomes From LENS
January 5, 2026 updated by: King's College London
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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
4400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Colette R Hirsch
- Phone Number: +44 (0) 20 7848 0697
- Email: colette.hirsch@kcl.ac.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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
This is where you will find people and organizations involved with this study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
April 1, 2032
Study Completion (Estimated)
April 1, 2032
Study Registration Dates
First Submitted
January 5, 2026
First Submitted That Met QC Criteria
January 5, 2026
First Posted (Actual)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
December 1, 2025
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)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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