Mood DisorderNCT02084979
A Controlled Trial of Patient Centered Telepsychiatry Interventions
A study testing telepsychiatry evaluation in people with Mood Disorder and Anxiety Disorder, run by University of California, Davis at 3 sites in United States.
Trial summary
This two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood Disorder, Anxiety Disorder, Substance Use Disorder
- What is being tested?
- telepsychiatry evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to 29 Apr 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 or older
- diagnosis of a mood disorder, anxiety disorder, or substance/alcohol abuse disorder(s)
- referred by PCP at participating site.
Who cannot join
- less than 18 years
- imminent suicidal ideation and/or plans
- immediate violent intentions or plans
- incarceration
- significant cognitive deficits
- patient who's PCP recommends not participating.
- PCP not at participating site
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UC Davis Primary Care Network
Auburn, California, 95603
UC Davis Primary Care Network Midtown
Sacramento, California, 95816
Communicare Health Centers Salud Clinic
West Sacramento, California, 95605
About this study
This two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.
Read the detailed description
This project addresses a critical public mental health problem: the need to improve access to high quality, mental health services for diverse populations through improving the flow of clinical work across care settings (primary care and specialty care) by implementing an efficient, provider compatible, administratively simple health IT solution: Asynchronous Telepsychiatry. To assess the impact of this novel approach, this two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.
Aim 1: To assess whether the ATP delivery model improves clinical OUTCOMES in adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:
H1: Higher scores over the course of treatment (better clinical trajectory) on the Short-Form-12 Health Survey (SF12- the primary outcome measure), the Clinical Global Impressions scale (CGI), the Who Disability Schedule (WHODAS) and the Global Assessment of Functioning (GAF) score.
H2 (Exploratory): Improved clinical trajectories on specific disorder scales, such as the PSQ9, the Hamilton Anxiety Scale (HAMA), the GAD7 and the AUDIT substance abuse scale over the those in the "usual care" arm.
Aim 2: To assess whether ATP improves the QUALITY of care for adult patients referred for psychiatric treatment by their PCPs and for PCP providers; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:
H1: higher levels of satisfaction (as measured by the patient rated Patient Telemedicine Satisfaction Survey which includes a general care satisfaction measure to be used across TAU and ATP groups and by the provider rated Telemedicine Provider Satisfaction Questionnaire) H2 (Exploratory- Spanish only speaking participants): will report more positive ratings of their provider on the Interpersonal Processes of Care Survey short form. Hypothesis: PCP's will be highly satisfied with the quality of ATP H3: PCPs with patients referred to the ATP arm will report high satisfaction ratings on the Telemedicine Provider Satisfaction Questionnaire. Aim 3: To assess whether ATP improves EFFICIENCY and REACH through reducing COSTS and increasing ACCESS for adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to care in the 'usual care" arm, care in the ATP arm will: H1: be more cost effective than "usual care" arm as measured by comprehensive economic data that will be collected from patient, provider, and payor perspectives.
H2: produce shorter wait-times for appointment and consultation feedback as measured by comprehensive efficiency data that will be collected from patient, provider, and payor perspectives.
- Conditions
- Mood Disorder, Anxiety Disorder, Substance Use Disorder
- Being tested
- telepsychiatry evaluation
- Keywords
- Primary care mental health consultation, Telepsychiatry, Asynchronous telepsychiatry
- Medical subject headings
- Mood Disorders, Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telepsychiatry evaluationBehavioural
telepsychiatry evaluation and consultation to primary care
| Study group | Role | What they receive |
|---|---|---|
| Asynchronous telepsychiatry | Experimental | Experimental Arm: Asynchronous telepsychiatry evaluation and consultation Receives: Behavioral: telepsychiatry evaluation |
| Synchronous telepsychiatry | Active comparator | Control Arm: Synchronous telepsychiatry evaluation and consultation Receives: Behavioral: telepsychiatry evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Functioning (GAF)
The GAF is used by clinicians to rate patients' social, occupational and psychological functioning Scale from 0-100 with 100 being the superior functioning and 1 being poor functioning (0 not enough info)
Measured: every 6 months for a 2 year follow-up period
The Clinical Global Impression (CGI)
The CGI is a widely used clinician rated scale that assesses a patient's response to mental health treatment.
Measured: every 6 months for a 2 year follow-up period
Secondary outcomes (8)
The Alcohol Use Disorders Identification Test (AUDIT)
developed by for the World Health Organization to identify persons whose alcohol consumption has become hazardous or harmful to their health and has been widely used in many studies. The AUDIT takes under 2 minutes to administer and is commonly used in primary care. Based on our previous research we have found a great deal of substance abuse comorbid with other disorders.
Measured: Every 6 months- 2 year follow-up period
The Patient Telemedicine Satisfaction Questionnaire
This measure is a modified version of the Parent Telemedicine Satisfaction Survey. : 1) technical functioning (items 2, 3, 5, 10); 2) comfort of patient and provider with the technology and perceived privacy (items 1, 4, 6); and 3) timely and geographic access to care (items 7, 8, 9). Items 11 and 12 assess global satisfaction with the telemedicine visit.
Measured: every 6 months- 2 year follow-up period
PHQ-9
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire to assist clinicians with diagnosing depression and monitoring treatment response. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV (Diagnostic and Statistical Manual Fourth Edition). This can help track a patients overall depression severity as well as the specific symptoms that are improving or not with treatment. The PHQ-9 was developed by Robert L. Spitzer, MD, Janet B.W. Williams, DSW, and Kurt Kroenke, MD, and colleagues at Columbia University
Measured: every 6 months for a 2 year follow-up period
The Generalized Anxiety Disorder 7 item (GAD-7)
The Generalized Anxiety Disorder 7 item (GAD-7) was developed to diagnose generalized anxiety disorders and has been validated in 2740 primary-care patients. It has a sensitivity of 89% and a specificity of 82%. It is moderately good at screening 3 other common anxiety disorders: panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and posttraumatic stress disorder (sensitivity 66%, specificity 81%). The GAD-7 was developed by Robert L. Spitzer, MD, and colleagues.
Measured: every 6 months for a 2 year follow-up period
Provider Telepsychiatry Satisfaction Questionnaire
The provider questionnaire was used in our preliminary studies. It reflects three domains of satisfaction reported to be highly correlated with global satisfaction for telemedicine: 1) technical functioning (items 2, 3, 5, 10); 2) comfort of patient and provider with the technology and perceived privacy (items 1, 4, 6); and 3) timely and geographic access to care (items 7, 8, 9). Items 11 and 12 assess global satisfaction with the telemedicine visit.
Measured: every 6 months for a 2 year follow-up period
PCL
PTSD Check List
Measured: every 6 months for a 2 year follow-up period
SF12
A widely validated and used self-report health survey consisting of 12 questions that produces a functional health, well-being, physical and mental health summary.
Measured: every 6 months for a 2 year follow-up period
Manual for WHO Disability Assessment Schedule - WHODAS 2.0
This instrument was developed by the WHO Classification, Terminology and Standards team, within the framework of the WHO/National Institutes of Health (NIH) Joint Project on Assessment and Classification of Disability.
Measured: every 6 months for a 2 year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2017
- Study completion29 Apr 2019
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 Mood DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Yellowlees, MD, Principal investigator, Professor UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084979
- Sponsor's protocol ID
- 522696
- Other IDs
- 1R01HS021477-01A1
- Status last verified
- Jun 2019
- First submitted
- 10 Mar 2014
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yellowlees PM, Burke MM, Gonzalez AD, Fisher A, Chan SR, Hilty DM, McCarron RM, Scher LM, Sciolla AF, Shore J, Xiong G, Fine J, Bannister J, Iosif AM. Patient and Provider Satisfaction with Asynchronous Versus Synchronous Telepsychiatry in Primary Care: A Secondary Mixed-Methods Analysis of a Randomized Controlled Trial. Telemed J E Health. 2024 Apr;30(4):e1049-e1063. doi: 10.1089/tmj.2023.0238. Epub 2023 Nov 22.
PubMed 38011623Lieng MK, Aurora MS, Kang Y, Kim JM, Marcin JP, Chan SR, Mouzoon JL, Tancredi DJ, Parish M, Gonzalez AD, Scher L, Xiong G, McCarron RM, Yellowlees P. Primary Care Physician Adherence to Telepsychiatry Recommendations: Intermediate Outcomes from a Randomized Clinical Trial. Telemed J E Health. 2022 Jun;28(6):838-846. doi: 10.1089/tmj.2021.0389. Epub 2021 Nov 2.
PubMed 34726542Yellowlees PM, Parish MB, Gonzalez AD, Chan SR, Hilty DM, Yoo BK, Leigh JP, McCarron RM, Scher LM, Sciolla AF, Shore J, Xiong G, Soltero KM, Fisher A, Fine JR, Bannister J, Iosif AM. Clinical Outcomes of Asynchronous Versus Synchronous Telepsychiatry in Primary Care: Randomized Controlled Trial. J Med Internet Res. 2021 Jul 20;23(7):e24047. doi: 10.2196/24047.
PubMed 33993104
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Patient Centered Telepsychiatry Interventions
- ClinicalTrials.gov ID
- NCT02084979
- Acronym / sponsor ID
- 522696
- Conditions
- Mood Disorder, Anxiety Disorder, Substance Use Disorder
- Keywords
- Primary care mental health consultation, Telepsychiatry, Asynchronous telepsychiatry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 12 Mar 2014 (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 two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.
Detailed description
This project addresses a critical public mental health problem: the need to improve access to high quality, mental health services for diverse populations through improving the flow of clinical work across care settings (primary care and specialty care) by implementing an efficient, provider compatible, administratively simple health IT solution: Asynchronous Telepsychiatry. To assess the impact of this novel approach, this two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.
Aim 1: To assess whether the ATP delivery model improves clinical OUTCOMES in adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:
H1: Higher scores over the course of treatment (better clinical trajectory) on the Short-Form-12 Health Survey (SF12- the primary outcome measure), the Clinical Global Impressions scale (CGI), the Who Disability Schedule (WHODAS) and the Global Assessment of Functioning (GAF) score.
H2 (Exploratory): Improved clinical trajectories on specific disorder scales, such as the PSQ9, the Hamilton Anxiety Scale (HAMA), the GAD7 and the AUDIT substance abuse scale over the those in the "usual care" arm.
Aim 2: To assess whether ATP improves the QUALITY of care for adult patients referred for psychiatric treatment by their PCPs and for PCP providers; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:
H1: higher levels of satisfaction (as measured by the patient rated Patient Telemedicine Satisfaction Survey which includes a general care satisfaction measure to be used across TAU and ATP groups and by the provider rated Telemedicine Provider Satisfaction Questionnaire) H2 (Exploratory- Spanish only speaking participants): will report more positive ratings of their provider on the Interpersonal Processes of Care Survey short form. Hypothesis: PCP's will be highly satisfied with the quality of ATP H3: PCPs with patients referred to the ATP arm will report high satisfaction ratings on the Telemedicine Provider Satisfaction Questionnaire. Aim 3: To assess whether ATP improves EFFICIENCY and REACH through reducing COSTS and increasing ACCESS for adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to care in the 'usual care" arm, care in the ATP arm will: H1: be more cost effective than "usual care" arm as measured by comprehensive economic data that will be collected from patient, provider, and payor perspectives.
H2: produce shorter wait-times for appointment and consultation feedback as measured by comprehensive efficiency data that will be collected from patient, provider, and payor perspectives.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asynchronous telepsychiatry | Experimental | Behavioral: telepsychiatry evaluationExperimental Arm: Asynchronous telepsychiatry evaluation and consultation |
| Synchronous telepsychiatry | Active comparator | Behavioral: telepsychiatry evaluationControl Arm: Synchronous telepsychiatry evaluation and consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 or older
- diagnosis of a mood disorder, anxiety disorder, or substance/alcohol abuse disorder(s)
- referred by PCP at participating site.
Key exclusion criteria (7 listed)
- less than 18 years
- imminent suicidal ideation and/or plans
- immediate violent intentions or plans
- incarceration
- significant cognitive deficits
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 |
|---|---|---|
| telepsychiatry evaluationtelepsychiatry evaluation and consultation to primary care | Behavioural | Asynchronous telepsychiatry, Synchronous telepsychiatry |
Primary outcome
Global Assessment of Functioning (GAF)
Time frame: every 6 months for a 2 year follow-up period
The GAF is used by clinicians to rate patients' social, occupational and psychological functioning Scale from 0-100 with 100 being the superior functioning and 1 being poor functioning (0 not enough info)
The Clinical Global Impression (CGI)
Time frame: every 6 months for a 2 year follow-up period
The CGI is a widely used clinician rated scale that assesses a patient's response to mental health treatment.
8 secondary outcomes
The Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Every 6 months- 2 year follow-up period
The Patient Telemedicine Satisfaction Questionnaire
Time frame: every 6 months- 2 year follow-up period
PHQ-9
Time frame: every 6 months for a 2 year follow-up period
The Generalized Anxiety Disorder 7 item (GAD-7)
Time frame: every 6 months for a 2 year follow-up period
Provider Telepsychiatry Satisfaction Questionnaire
Time frame: every 6 months for a 2 year follow-up period
PCL
Time frame: every 6 months for a 2 year follow-up period
SF12
Time frame: every 6 months for a 2 year follow-up period
Manual for WHO Disability Assessment Schedule - WHODAS 2.0
Time frame: every 6 months for a 2 year follow-up period
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 11 Jun 2019.
- Derived from this study: PubMed 38011623Yellowlees PM, Burke MM, Gonzalez AD, Fisher A, Chan SR, Hilty DM, McCarron RM, Scher LM, Sciolla AF, Shore J, Xiong G, Fine J, Bannister J, Iosif AM. Patient and Provider Satisfaction with Asynchronous Versus Synchronous Telepsychiatry in Primary Care: A Secondary Mixed-Methods Analysis of a Randomized Controlled Trial. Telemed J E Health. 2024 Apr;30(4):e1049-e1063. doi: 10.1089/tmj.2023.0238. Epub 2023 Nov 22.
- Derived from this study: PubMed 34726542Lieng MK, Aurora MS, Kang Y, Kim JM, Marcin JP, Chan SR, Mouzoon JL, Tancredi DJ, Parish M, Gonzalez AD, Scher L, Xiong G, McCarron RM, Yellowlees P. Primary Care Physician Adherence to Telepsychiatry Recommendations: Intermediate Outcomes from a Randomized Clinical Trial. Telemed J E Health. 2022 Jun;28(6):838-846. doi: 10.1089/tmj.2021.0389. Epub 2021 Nov 2.
- Derived from this study: PubMed 33993104Yellowlees PM, Parish MB, Gonzalez AD, Chan SR, Hilty DM, Yoo BK, Leigh JP, McCarron RM, Scher LM, Sciolla AF, Shore J, Xiong G, Soltero KM, Fisher A, Fine JR, Bannister J, Iosif AM. Clinical Outcomes of Asynchronous Versus Synchronous Telepsychiatry in Primary Care: Randomized Controlled Trial. J Med Internet Res. 2021 Jul 20;23(7):e24047. doi: 10.2196/24047.
- Individual participant dataSharing planned: No
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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.
Peter Yellowlees, MD principal investigator
Professor UC Davis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telepsychiatry evaluation in people with Mood Disorder and Anxiety Disorder, run by University of California, Davis at 3 sites 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 3 inclusion and 7 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Global Assessment of Functioning (GAF) (time frame: every 6 months for a 2 year follow-up period). 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 NCT02084979, 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 11 Jun 2019.