Using a mental health chatbot, Tess, to relieve symptoms of depression and anxiety
| ISRCTN | ISRCTN61214172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61214172 |
| Secondary identifying numbers | 10.2196/mental.9782 |
- Submission date
- 31/10/2018
- Registration date
- 19/11/2018
- Last edited
- 09/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Students in need of mental health care face many barriers including cost, location, availability, and stigma. Studies show that digital mental health solutions offer a less intensive and more cost-effective alternative for reducing symptoms of depression and anxiety. Artificial intelligence (AI) offers a scalable solution as the demand for affordable, convenient, lasting, and secure support grows. The aim of this study is to assess the feasibility of using an AI chatbot called Tess to deliver emotional support and reduce self-identified symptoms of depression and anxiety in college students.
Who can participate?
University students enrolled in the USA are invited to participate regardless of gender, race, or socioeconomic status. As healthy volunteers, students are expected to speak English, be over the age of 18, and to sign the informed consent in order to participate.
What does the study involve?
Participants are randomly allocated to one of three groups. The control group receive an e-book with no access to the AI, Tess, until after the study has ended. Test group 1 receive unlimited access to Tess with daily check-ins for two weeks. Test group 2 receive unlimited access to Tess with bi-weekly check-ins for four weeks.
What are the possible benefits and risks of participating?
By participating in this study, students gained free access to a unique and on-demand emotional support service that usually costs $5.00 month. Students are also offered an incentive for participating in the form of a $20 Amazon e-gift card upon completion of the study. Students are offered a secure and confidential space to talk about sensitive issues they may otherwise have a hard time sharing with others. While there were no clinical risks observed in the results of this study, one potential risk may have been that interacting with the AI system, Tess, may lead a student to desire more support in a clinical setting which may require financial and other resources to achieve.
Where is the study run from?
The study was conducted by primary investigator, Russell Fulmer, PhD from Northwestern University in Illinois, USA. Dr. Fulmer collaborated with the vendor called X2 AI Inc., which funded and provided the AI service called Tess to deliver support to participants during the study.
When is the study starting and how long is it expected to run for?
July 2017 to October 2017
Who is funding the study?
X2 AI Inc. (USA)
Who is the main contact?
Dr Russell Fulmer
russell.fulmer@northwestern.edu
Contact information
Scientific
995 Market St. Suite 209
San Francisco
94103
United States of America
 ORCID ID |
0000-0003-3667-9636 |
|---|
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | ISRCTN61214172_PIS_[Informed Consent].pdf |
| Scientific title | Using psychological artificial intelligence (Tess) to relieve symptoms of depression and anxiety: randomized controlled trial |
| Study acronym | Tess RCT |
| Study objectives | This study aimed to assess the feasibility and efficacy of using an integrative psychological AI, Tess, to reduce self-identified symptoms of depression and anxiety in college students. |
| Ethics approval(s) | This study was considered exempt from ethics approval and registration in a public trials registry, since it involved a nonclinical population of college students. The support delivered by the artificial intelligence service called Tess does not qualify as a clinical intervention. Participants in the control group received only a brief self-help e-book written by the National Institute of Mental Health (NIMH). Program evaluation outcomes from this study will support content enhancements for future IRB approved studies. |
| Health condition(s) or problem(s) studied | Providing on-demand support for students with self-identified, and non-clinical range, symptoms of depression and anxiety |
| Intervention | Confirmed participants were randomized via a computer algorithm that automatically generated a number between 0 and 2, and then placed into one of three groups. No Intervention: Control Group participants were sent a link to NIMH's self-help eBook. Test Group 1 participants were granted unlimited access to the Tess chatbot through Facebook messenger for 2 weeks. Test Group 2 participants were granted unlimited access to the Tess chatbot through Facebook messenger for 4 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Depression severity assessed using the Patient Health Questionnaire-9 (PHQ9) at baseline, 2 weeks, and 4 weeks for the control group, at baseline and 2 weeks for Test Group 1 and at baseline and 4 weeks for Test Group 2 2. Generalized anxiety disorder severity assessed using Generalized Anxiety Disorder-7 (GAD7) questionnaire at baseline, 2 weeks, and 4 weeks for the control group, at baseline and 2 weeks for Test Group 1 and at baseline and 4 weeks for Test Group 2 3. Positive and negative mood assessed using the Positive and Negative Affect Schedule (PANAS) questionnaire at baseline, 2 weeks, and 4 weeks for the control group, at baseline and 2 weeks for Test Group 1 and at baseline and 4 weeks for Test Group 2 |
| Secondary outcome measures | User satisfaction assessed using a survey at week 4 for the control group, week 2 for Test Group 1 and at week 4 for Test Group 2 |
| Overall study start date | 01/07/2017 |
| Completion date | 16/10/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 115 |
| Key inclusion criteria | 1. Current enrollment at a university in the United States 2. Aged 18 years and older (screened at the first level via checkbox confirmation) 3. Able to read English (implied) 4. Informed consent signed 5. To guard against compromise, for example, from malicious bots, all potential participants were sent an email requesting that they respond using their university email denoting their confirmation |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/08/2017 |
| Date of final enrolment | 29/08/2017 |
Locations
Countries of recruitment
- United States of America
Study participating centres
60201
United States of America
San Francisco
94103
United States of America
Sponsor information
Industry
995 Market St. Suite 209
San Francisco
94103
United States of America
| Phone | +1 (0)2489356366 |
|---|---|
| angie@x2ai.com | |
| Website | https://www.x2ai.com/ |
University/education
633 Clark Street
Evanston
60208
United States of America
| Website | https://www.northwestern.edu/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 29/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This study has been accepted for publication through JMIR and is available for download here: https://preprints.jmir.org/preprint/9782/accepted |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Angie Joerin (angie@x2ai.com). Type of data: SPSS output. Data requests may take up to 90 days to process and may be shared only to those who meet the criteria defined below. Data may be shared only through secure, password protected platforms and only to researchers or organizations who submit a written request with aim to further evaluate the feasibility, generalizability, efficacy or other of using the artificial intelligence system called Tess to deliver emotional support. The X2 ethical board and Northwestern University primary investigator maintain the right to refuse access to data. Participants signed an electronic consent form and agreed to the services privacy policy (https://www.x2ai.com/privacy) before participating in the study. Participants were randomly selected into three groups and automatically assigned a unique user ID. The system automatically de-identified transcripts, which were stored on a HIPAA compliant server in which only a select few individuals from the core research team were granted security level access during the duration of the study. The terms of use for the system used to deliver support during this study are described in this link: https://www.x2ai.com/terms. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/12/2018 | Yes | No | |
| Participant information sheet | 09/01/2024 | No | Yes |
Additional files
Editorial Notes
09/01/2024: Patient information sheet added as an additional file.
18/12/2018: Publication reference added.
