Clinical trial NCT02656641: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety States, Neurotic
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Immaculata University
First posted: 2016-01-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in depressive symptoms as assessed by Patient Health Questionnaire-9
timeFrame: Baseline and end of treatment up to 10 weeks
measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder 7-Item Scale
timeFrame: Baseline and end of treatment up to 10 weeks
Secondary outcomes:
measure: World Health Organization - Quality of Life BREF Scale
timeFrame: Baseline and end of treatment up to 10 weeks
measure: Schwartz Outcome Scale
timeFrame: Baseline and end of treatment up to 10 weeks
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Christiana Care Health System - Adult Bridge Program
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Krystal G Ludwig, MA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.