Using the PHQ-9 and GAD-7 as Feedback Instruments in Brief Psychotherapy

Using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 7-Item Scale (GAD-7) as Feedback Instruments in Brief Psychotherapy

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Anxiety States, Neurotic
• Intervention / Treatment: Behavioral: Continuous Client Feedback; Behavioral: Continuous Self Feedback

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19801
      • Christiana Care Health System - Adult Bridge Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Clients will complete symptom and quality of life scales before their first session and before their last or tenth session, whichever occurs first. Clients will not complete any scales during other sessions.
Experimental: Continuous Client Feedback; Clients will complete symptom and quality of life scales before their first session and before their last or tenth session, whichever occurs first. Clients will then complete symptoms scales, specifically the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-Item Scale before each other session. The treating clinician will review and discuss their results and at the beginning of each session.	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.
Experimental: Continuous Self Feedback; Clients will complete symptom and quality of life scales before their first session and before their last or tenth session, whichever occurs first. Clients will then complete symptoms scales, specifically the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-Item Scale before each other session. The treating clinician will not have access to these results.	Behavioral: Continuous Self Feedback; Clients complete rating scales before each therapy session. Progress is not reviewed with the therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms as assessed by Patient Health Questionnaire-9	Assesses depressive symptoms	Baseline and end of treatment up to 10 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Schwartz Outcome Scale	Monitors treatment outcomes	Baseline and end of treatment up to 10 weeks

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Collaborators: Immaculata University
• Investigators: Principal Investigator: Krystal G Ludwig, MA, Christiana Care Health Services

Publications and helpful links

General Publications

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• 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. doi: 10.1001/jama.282.18.1737.
• 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. doi: 10.1207/S15327752JPA7303_5.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Depression; Anxiety Disorders
• Other Study ID Numbers: 35156