- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07339917
Undersøker prediktorer for resultater fra LENS
Undersøkelse av prediktorer for resultater fra LENS, en kognitiv biasmodifikasjon for tolkning (CBM-I) trening, hos voksne med økt angst
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Colette R Hirsch
- Telefonnummer: +44 (0) 20 7848 0697
- E-post: colette.hirsch@kcl.ac.uk
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Participants who have taken part in previous genetic cohort studies, namely GLAD, TEDS and Genes & Health, will be invited to participate in the study.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
General Anxiety Disorder-7 score
Tidsramme: 8 week follow up
|
General Anxiety Disorder-7 score on GAD-7 questionnaire |
8 week follow up
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Colette R Hirsch, King's College London
- Hovedetterforsker: Thalia Eley, King's College London
- Hovedetterforsker: Gerome Breen, King's College London
- Hovedetterforsker: Ewan Carr, King's College London
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 363721
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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