Investigating Predictors of Outcomes From LENS

NCT07339917 | Not Yet Recruiting DMC

• 1 other identifier: 363721
• Study Type: observational
• Target: 4,400
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• General Anxiety Disorder-7 score

  General Anxiety Disorder-7 score on GAD-7 questionnaire

  8 week follow up

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette R Hirsch

CONTACT

+44 (0) 20 7848 0697; colette.hirsch@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: January 14, 2026

Record last verified: 2025-12