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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03457922
Other study ID # 44584
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 5, 2018
Est. completion date October 6, 2019

Study information

Verified date June 2020
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is examining the impact of a therapy group for all anxiety disorders provided by the Stanford Department of Psychiatry and Behavioral Sciences's Psychosocial Treatment Clinic on anxiety symptoms, impairment, and access to quality mental health care.


Description:

Anxiety disorders are prevalent, impairing, and often precede other psychiatric and medical comorbidity (Kessler et al, 2005). Cognitive Behavior Therapy (CBT) and Acceptance and Commitment Therapy (ACT) are effective, evidence-based treatments for anxiety disorders that can be delivered in either a group or individual format (Deacon & Abramowitz, 2004; Arch et al 2012). Traditionally, group therapy has been delivered a single diagnosis at a time. This presents challenges to care delivery, however, because a sufficient number of patients with the same diagnosis and the same availability in their schedule must be assembled in order to start a group. Fortunately, CBT and ACT can be used to target key trans-diagnostic constructs such as excessive worry, avoidance, and fear of negative evaluation that may occur in many anxiety diagnoses. Indeed, emerging research suggests these constructs may be closer to the etiological dysfunction in anxiety disorders than the diagnoses themselves and may therefore be the best treatment targets (Craske, 2012). Because of this, there is now movement towards trans-diagnostic approaches that flexibly apply core principles of CBT and ACT to any anxiety disorder.

Group therapy is a cost-efficient and effective care delivery model that is also generally acceptable to patients with anxiety disorders. However, individual therapy is often preferred (Sharp et al, 2004), perhaps due to greater personalization of care relative to standard group therapy. To address this concern the investigators aim to use a pre-treatment assessment to develop a personalized plan for each patient entering a trans-diagnostic anxiety group.

In order to evaluate the effectiveness of this approach, patients enrolled in the group who consent to participate in research will complete assessments of anxiety and related symptoms, quality of life, and cognitive function before and after therapy.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date October 6, 2019
Est. primary completion date August 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18+

- Enrolled in a trans-diagnostic group therapy for anxiety disorders in the Stanford Psychiatry & Behavioral Sciences' Psychosocial Treatment Clinic.

- English fluency

Exclusion Criteria:

- Unable to provide informed consent

- Acute safety concerns (e.g., suicidality requiring a higher level of care)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Stanford University Department of Psychiatry & Behavioral Sciences Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Anxiety Severity and Impairment Scale [OASIS] Measures overall anxiety severity and anxiety-related impairment due to any anxiety disorder. Total scores are computed by summing scores from all 5 items. Total score ranges from 0 to 20, with higher scores indicating higher severity and impairment of anxiety symptoms. Reduction in OASIS scores therefore indicates better outcome. 12 weeks
Secondary Sheehan Disability Scale [SDS] Measures disability. Total scores are computed by summing scores from all 3 items. Total score ranges from 0 to 30, with higher scores indicating greater disability. Reduction in SDS scores therefore indicates better outcome. 12 weeks
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