Anxiety DisordersNCT06370559
Relationship Between Repetitive Negative Thinking and CBT Outcomes
An observational study of Anxiety Disorders and Obsessive-Compulsive Disorder, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Obsessive-Compulsive Disorder, Post-traumatic Stress Disorder
- How many people
- 320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2022to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Our sample consists of clients who have completed a course of CBT treatment from the Centre of Anxiety Disorders and Trauma between 01/01/2022 to 01/02/2024. Patients are typically seen for 12-20 sessions.
Who may be able to join
- 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.
Who cannot join
- Participants who dropped out of treatment
- Participants who did not complete online questionnaires.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Anxiety Disorders and Trauma
London, SE5 8AZ
About this study
Official title: The Relationship Between Repetitive Negative Thinking (RNT) and CBT Treatment Outcome Within a Specialist Anxiety Disorders Clinic.
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:
Read more
- 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.
Read the detailed description
We are looking to examine how repetitive negative thinking (RNT; 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.
- Conditions
- Anxiety Disorders, Obsessive-Compulsive Disorder, Post-traumatic Stress Disorder, Social Anxiety Disorder, Specific Phobia, Panic Disorder
- Keywords
- Rumination, Ruminative Thinking Questionnaire (RTQ-10), Cognitive Beavioural Therapy (CBT), Outcomes
- Medical subject headings
- Anxiety Disorders, Obsessive-Compulsive Disorder, Stress Disorders, Post-Traumatic, Phobia, Social, Phobia, Specific, Panic Disorder, Body Dysmorphic Disorders, Rumination Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Repetitive Ruminative Thinking Questionnaire score
Change in RTQ from pre- to post-treatment
Measured: From pre treatment to post treatment for CBT at CADAT (an average of 12-20 weeks)
Change in disorder-specific measure score
Change in disorder-specific measure scores from pre- to post-treatment
Measured: From pre treatment to post treatment for CBT at CADAT (an average of 12-20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jan 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- South London and Maudsley NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370559
- Sponsor's protocol ID
- 339042
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Repetitive Negative Thinking (RNT) and CBT Treatment Outcome Within a Specialist Anxiety Disorders Clinic.
- ClinicalTrials.gov ID
- NCT06370559
- Acronym / sponsor ID
- 339042
- Conditions
- Anxiety Disorders, Obsessive-Compulsive Disorder, Post-traumatic Stress Disorder, Social Anxiety Disorder, Specific Phobia, Panic Disorder
- Keywords
- Rumination, Ruminative Thinking Questionnaire (RTQ-10), Cognitive Beavioural Therapy (CBT), Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- South London and Maudsley NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 17 Apr 2024 (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.
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.
Detailed description
We are looking to examine how repetitive negative thinking (RNT; 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our sample consists of clients who have completed a course of CBT treatment from the Centre of Anxiety Disorders and Trauma between 01/01/2022 to 01/02/2024. Patients are typically seen for 12-20 sessions.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants who dropped out of treatment
- Participants who did not complete online questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Repetitive Ruminative Thinking Questionnaire score
Time frame: From pre treatment to post treatment for CBT at CADAT (an average of 12-20 weeks)
Change in RTQ from pre- to post-treatment
Change in disorder-specific measure score
Time frame: From pre treatment to post treatment for CBT at CADAT (an average of 12-20 weeks)
Change in disorder-specific measure scores from pre- to post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Obsessive-Compulsive Disorder, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Repetitive Ruminative Thinking Questionnaire score (time frame: From pre treatment to post treatment for CBT at CADAT (an average of 12-20 weeks)). The study lists 2 primary outcomes in all. 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 17 Apr 2024.