Investigating Predictors of Outcomes From LENS

Official title

Investigating Predictors of Outcomes From LENS, a Cognitive Bias Modification for Interpretation (CBM-I) Training, in Adults With Elevated Anxiety

Overview

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.

Interventions

• Device 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 ses

Primary outcome measures

• General Anxiety Disorder-7 score [Time frame: 8 week follow up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07339917 · 363721

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗