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

Primary Purpose

Depressive Symptoms, Anxiety States, Neurotic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Client Feedback
Continuous Self Feedback
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christiana Care Health System - Adult Bridge Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Continuous Client Feedback

Continuous Self Feedback

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in depressive symptoms as assessed by Patient Health Questionnaire-9
Assesses depressive symptoms
Change in anxiety symptoms as assessed by Generalized Anxiety Disorder 7-Item Scale
Assesses anxiety symptoms

Secondary Outcome Measures

World Health Organization - Quality of Life BREF Scale
Assesses domains of physical health, psychological health, social relationships, and environment
Schwartz Outcome Scale
Monitors treatment outcomes

Full Information

First Posted
November 25, 2015
Last Updated
July 18, 2017
Sponsor
Christiana Care Health Services
Collaborators
Immaculata University
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1. Study Identification

Unique Protocol Identification Number
NCT02656641
Brief Title
Using the PHQ-9 and GAD-7 as Feedback Instruments in Brief Psychotherapy
Official Title
Using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 7-Item Scale (GAD-7) as Feedback Instruments in Brief Psychotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
Collaborators
Immaculata University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety States, Neurotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Continuous Client Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuous Self Feedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Continuous Client Feedback
Intervention Description
Clients complete rating scales before each therapy session. The therapist then views these results and discusses treatment progress with the client during the session.
Intervention Type
Behavioral
Intervention Name(s)
Continuous Self Feedback
Intervention Description
Clients complete rating scales before each therapy session. Progress is not reviewed with the therapist.
Primary Outcome Measure Information:
Title
Change in depressive symptoms as assessed by Patient Health Questionnaire-9
Description
Assesses depressive symptoms
Time Frame
Baseline and end of treatment up to 10 weeks
Title
Change in anxiety symptoms as assessed by Generalized Anxiety Disorder 7-Item Scale
Description
Assesses anxiety symptoms
Time Frame
Baseline and end of treatment up to 10 weeks
Secondary Outcome Measure Information:
Title
World Health Organization - Quality of Life BREF Scale
Description
Assesses domains of physical health, psychological health, social relationships, and environment
Time Frame
Baseline and end of treatment up to 10 weeks
Title
Schwartz Outcome Scale
Description
Monitors treatment outcomes
Time Frame
Baseline and end of treatment up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krystal G Ludwig, MA
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System - Adult Bridge Program
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16717171
Citation
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.
Results Reference
background
PubMed Identifier
10568646
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. doi: 10.1001/jama.282.18.1737.
Results Reference
background
PubMed Identifier
10689649
Citation
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.
Results Reference
background

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

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