Depressive SymptomsNCT02656641
Using the PHQ-9 and GAD-7 as Feedback Instruments in Brief Psychotherapy
A study testing Continuous Client Feedback and Continuous Self Feedback in people with Depressive Symptoms and Anxiety States, Neurotic, run by Christiana Care Health Services at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Symptoms, Anxiety States, Neurotic
- What is being tested?
- Continuous Client Feedback and Continuous Self Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder, or Adjustment Disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System - Adult Bridge Program
Wilmington, Delaware, 19801
About this study
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
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.
- Conditions
- Depressive Symptoms, Anxiety States, Neurotic
- Being tested
- Continuous Client Feedback, Continuous Self Feedback
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Client FeedbackBehavioural
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 FeedbackBehavioural
Clients complete rating scales before each therapy session. Progress is not reviewed with the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Continuous Client Feedback | Experimental | 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. Receives: Behavioral: Continuous Client Feedback |
| Continuous Self Feedback | Experimental | 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. Receives: Behavioral: Continuous Self Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms as assessed by Patient Health Questionnaire-9
Assesses depressive symptoms
Measured: 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
Measured: Baseline and end of treatment up to 10 weeks
Secondary outcomes (2)
World Health Organization - Quality of Life BREF Scale
Assesses domains of physical health, psychological health, social relationships, and environment
Measured: Baseline and end of treatment up to 10 weeks
Schwartz Outcome Scale
Monitors treatment outcomes
Measured: Baseline and end of treatment up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startNov 2015
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Immaculata University
- Responsible party
- Sponsor
- Investigators
- Krystal G Ludwig, MA, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656641
- Sponsor's protocol ID
- 35156
- Status last verified
- Jul 2017
- First submitted
- 25 Nov 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16717171Spitzer 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.
PubMed 10568646Blais 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.
PubMed 10689649
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02656641
- Acronym / sponsor ID
- 35156
- Conditions
- Depressive Symptoms, Anxiety States, Neurotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Immaculata University
- Study start
- Nov 2015
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Continuous Client Feedback | Experimental | Behavioral: Continuous Client FeedbackClients 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. |
| Continuous Self Feedback | Experimental | Behavioral: Continuous Self FeedbackClients 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder, or Adjustment Disorder
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Client FeedbackClients complete rating scales before each therapy session. The therapist then views these results and discusses treatment progress with the client during the session. | Behavioural | Continuous Client Feedback |
| Continuous Self FeedbackClients complete rating scales before each therapy session. Progress is not reviewed with the therapist. | Behavioural | Continuous Self Feedback |
Primary outcome
Change in depressive symptoms as assessed by Patient Health Questionnaire-9
Time frame: Baseline and end of treatment up to 10 weeks
Assesses depressive symptoms
Change in anxiety symptoms as assessed by Generalized Anxiety Disorder 7-Item Scale
Time frame: Baseline and end of treatment up to 10 weeks
Assesses anxiety symptoms
2 secondary outcomes
World Health Organization - Quality of Life BREF Scale
Time frame: Baseline and end of treatment up to 10 weeks
Schwartz Outcome Scale
Time frame: Baseline and end of treatment up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 10568646Spitzer 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.
- Background: PubMed 10689649Blais 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krystal G Ludwig, MA principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Client Feedback and Continuous Self Feedback in people with Depressive Symptoms and Anxiety States, Neurotic, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms as assessed by Patient Health Questionnaire-9 (time frame: Baseline and end of treatment up to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656641, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.