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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02656641
Other study ID # 35156
Secondary ID
Status Completed
Phase N/A
First received November 25, 2015
Last updated July 18, 2017
Start date November 2015
Est. completion date August 31, 2016

Study information

Verified date July 2017
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the effects of client feedback, using the Patient Health Questionnaire - 9 and Generalized Anxiety Disorder 7-Item Scale, on depression and anxiety in individuals undergoing brief psychotherapy. Client feedback allows therapists to monitor treatment progress in real time. Identifying an easily accessible treatment intervention, which utilizes commonly used scales, that potentially enhances the effect of brief psychotherapy and improves treatment outcomes is a valuable endeavor with clear implications for therapy practices. It is hypothesized that clients who complete these scales each session will show greater symptom improvement than clients who do not complete the scales.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date August 31, 2016
Est. primary completion date August 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder, or Adjustment Disorder

Exclusion Criteria:

- Require a higher level of care than brief psychotherapy, or have been diagnosed with an intellectual disability, personality disorder, substance use disorder, or major medical illness

Study Design


Intervention

Behavioral:
Continuous Client Feedback
Clients complete rating scales before each therapy session. The therapist then views these results and discusses treatment progress with the client during the session.
Continuous Self Feedback
Clients complete rating scales before each therapy session. Progress is not reviewed with the therapist.

Locations

Country Name City State
United States Christiana Care Health System - Adult Bridge Program Wilmington Delaware

Sponsors (2)

Lead Sponsor Collaborator
Christiana Care Health Services Immaculata University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Blais MA, Lenderking WR, Baer L, deLorell A, Peets K, Leahy L, Burns C. Development and initial validation of a brief mental health outcome measure. J Pers Assess. 1999 Dec;73(3):359-73. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in depressive symptoms as assessed by Patient Health Questionnaire-9 Assesses depressive symptoms Baseline and end of treatment up to 10 weeks
Primary Change in anxiety symptoms as assessed by Generalized Anxiety Disorder 7-Item Scale Assesses anxiety symptoms Baseline and end of treatment up to 10 weeks
Secondary World Health Organization - Quality of Life BREF Scale Assesses domains of physical health, psychological health, social relationships, and environment Baseline and end of treatment up to 10 weeks
Secondary Schwartz Outcome Scale Monitors treatment outcomes Baseline and end of treatment up to 10 weeks
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