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Clinical Trials/ISRCTN16933121
ISRCTN16933121
Completed
未知

Effects of self-guided digital cognitive behavioural therapy on symptoms of generalized anxiety disorder and related disorders: a randomised controlled trial

niversity of Oxford0 sites224 target enrollmentMay 27, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Oxford
Enrollment
224
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 27, 2021
End Date
March 14, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Adults aged \=18 years old
  • 2\. Score \=10 on the 7\-item Generalized Anxiety Disorder scale (GAD\-7\)
  • 3\. Screen positive for GAD diagnosis against Diagnostic and Statistical Manual of Mental Disorders (DSM\-5\) criteria and phone call verification of diagnosis using a modified version of the Structured Clinical Interview for DSM\-5 (SCID)
  • 4\. Either not on psychotropic medication or on a stable dose for at least 4 weeks before screening assessment
  • 5\. Oral and written fluency in English
  • 6\. Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the approved informed consent form

Exclusion Criteria

  • 1\. Currently receiving or be expecting to start CBT for anxiety during study participation, or have previously received CBT for anxiety in the past 12\-months (self\-report)
  • 2\. Self\-reported diagnosis of schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder; recent trauma to the head or brain damage; recent inpatient psychiatric admission or crisis team support
  • 3\. Cognitive impairment that does not allow participants to consent or follow treatment instructions (self\-report)
  • 4\. Physical health concerns necessitating surgery or with \<6 months to live (self\-report)
  • 5\. Hearing or vision impairment that prevents effective use of the audio\-visual content of digital CBT

Outcomes

Primary Outcomes

Not specified

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