AnxietyNCT07339917
Investigating Predictors of Outcomes From LENS
An observational study of Anxiety, run by King's College London.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Learning Effective New Strategies (LENS)
- Type of treatment
- Medical device
- How many people
- 4,400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Anxiety
- Being tested
- Learning Effective New Strategies (LENS)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning Effective New Strategies (LENS)Device
Learning Effective New Strategies (LENS) is a Class I digital mental health intervention developed by King's College London, of which the overall purpose is to shift the way people think about ambiguous situations to be more positive and helpful. LENS achieves this through a drill-like training where users are prompted to visualise positive conclusions to numerous situations which are ambiguous and could be interpreted in either negative or positive ways. This training involves completing 12 sessions over 4 weeks. This type of training is known as cognitive bias modification for interpretation bias (CBM-I), which trains individuals to think in a more positive, adaptive way. The intended use of LENS is to reduce anxiety, depression and/or repetitive negative thinking in individuals with anxiety (low to high levels), depression (low to moderate levels), and/or repetitive negative thinking (moderate to high levels).
What is being measured
The primary outcome is the main question the study is designed to answer.
General Anxiety Disorder-7 score
General Anxiety Disorder-7 score on GAD-7 questionnaire
Measured: 8 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colette R Hirsch, Principal investigator, King's College LondonThalia Eley, Principal investigator, King's College LondonGerome Breen, Principal investigator, King's College LondonEwan Carr, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339917
- Sponsor's protocol ID
- 363721
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Predictors of Outcomes From LENS, a Cognitive Bias Modification for Interpretation (CBM-I) Training, in Adults With Elevated Anxiety
- ClinicalTrials.gov ID
- NCT07339917
- Acronym / sponsor ID
- 363721
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning Effective New Strategies (LENS)Learning Effective New Strategies (LENS) is a Class I digital mental health intervention developed by King's College London, of which the overall purpose is to shift the way people think about ambiguous situations to be more positive and helpful. LENS achieves this through a drill-like training where users are prompted to visualise positive conclusions to numerous situations which are ambiguous and could be interpreted in either negative or positive ways. This training involves completing 12 sessions over 4 weeks. This type of training is known as cognitive bias modification for interpretation bias (CBM-I), which trains individuals to think in a more positive, adaptive way. The intended use of LENS is to reduce anxiety, depression and/or repetitive negative thinking in individuals with anxiety (low to high levels), depression (low to moderate levels), and/or repetitive negative thinking (moderate to high levels). | Device | – |
Primary outcome
General Anxiety Disorder-7 score
Time frame: 8 week follow up
General Anxiety Disorder-7 score on GAD-7 questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colette R Hirsch principal investigator
King's College London
Thalia Eley principal investigator
King's College London
Gerome Breen principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colette R Hirsch (+44 (0) 20 7848 0697, colette.hirsch@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Anxiety Disorder-7 score (time frame: 8 week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.