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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06370559
Other study ID # 339042
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date February 1, 2024

Study information

Verified date April 2024
Source South London and Maudsley NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about the role of repetitive negative thinking (measured by the RTQ) in adult populations from an anxiety disorders and trauma clinic. The main questions it aims to answer are: - Whether the repetitive negative thinking can be used to predict i. initial symptom severity, and ii. therapy outcome (measured by change in scores on disorder specific measures). - Whether change in RTQ mediates change in outcome Participants are sent weekly questionnaires that measure their progress. Within these questionnaires are the RTQ and other disorder-specific measures that we will be analysing. Researchers may also compare clients with different disorders to see the accuracy the RTQ can predict treatment outcomes for each disorder.


Description:

We are looking to examine how repetitive negative thinking (RNTÍž i.e. rumination and worry), measured by the repetitive thinking questionnaire (RTQ), affects the outcomes of Cognitive Behavioural Therapy (CBT) for anxiety and trauma disorders. Our study will involve looking over data collected from clients who completed treatment at the Centre for Anxiety Disorders and Trauma (CADAT) from 01/01/2022 to 31/03/2024, we will look at data from before they started treatment, whilst in treatment and once they completed treatment. This is an important issue to address as there is little guidance within existing CBT protocols on to how to identify and target RNT during treatment. Evidence also suggests that not only does RNT maintain anxiety disorders, but it can also interfere with therapy outcome. Research has found that patients receiving CBT for PTSD who displayed high-levels of rumination within their early CBT sessions had poorer outcomes in therapy. Our aim is to formally analyse the relationship between scores on the RTQ and both symptom severity and CBT treatment outcome for anxiety disorders. This would help us to test our hypotheses about the relationship (i.e. those with high RNT have poorer treatment outcomes and changes in RNT predict outcome across a range of anxiety and trauma disorders) and provide a basis for augmenting our existing treatments with interventions that specifically target this process.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must have completed a course of CBT treatment at CADAT for one of the following anxiety disorders: OCD, PTSD, Panic Disorder, Health Anxiety, Emetophobia, Specific Phobia, Social Phobia, BDD, GAD, DPD or Hoarding. - Participants must have completed regular questionnaires throughout their treatment. Exclusion Criteria: - Participants who dropped out of treatment - Participants who did not complete online questionnaires.

Study Design


Locations

Country Name City State
United Kingdom Centre for Anxiety Disorders and Trauma London

Sponsors (1)

Lead Sponsor Collaborator
South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Repetitive Ruminative Thinking Questionnaire score Change in RTQ from pre- to post-treatment From pre treatment to post treatment for CBT at CADAT (an average of 12-20 weeks)
Primary Change in disorder-specific measure score Change in disorder-specific measure scores from pre- to post-treatment From pre treatment to post treatment for CBT at CADAT (an average of 12-20 weeks)
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