Using an Online Psychotherapy Program and AI-assisted Interventions for Postsecondary Student Mental Health

NCT05754723 | Withdrawn

• 1 other identifier: 6034514
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of mental health challenges and disorders in post-secondary students, demands accessible and efficacious care. Online psychotherapy and psychoeducation programs have shown significant effectiveness in mitigating the risk and clinical symptoms of various mental health disorders. Additionally, artificial intelligence (AI) has become an accessible, effective, and scalable tool supporting the delivery of healthcare. Therefore, the primary objective of this study is to develop an AI-driven online mental health care hub in the Kingston, Frontenac, Lennox \& Addington region for post-secondary students. . This hub will deliver equitable, efficacious, and cost-effective online psychoeducation and psychotherapy in the form of online diagnosis-specific cognitive behavioural therapy (e-CBT). The hub's virtual design aims to adequately address existing gaps in the mental healthcare of these individuals and alleviate the burden placed on mental health services in Canada. Using a rigorous implementation framework, the development of this hub is designed as a multiphase study with three phases. (1) Pre-adoption phase: will assess post-secondary students' current mental health landscape through surveys and focus groups. This information will be used in the development of our online psychoeducation and diagnosis-specific e-CBT programs. (2) Delivery phase: will determine the efficacy and cost-effectiveness of the online psychoeducation and diagnosis-specific e-CBT programs by comparing them to treatment as usual. (3) Post-adoption phase: the collected data from these programs will be analyzed and shared with key stakeholders to guide continuous program scaling and improvement.

Conditions

Mental Health Issue

Keywords

Student; Mental Health

Outcome Measures

Primary Outcomes (8)

• Change in anxiety severity (GAD-7)

  Generalized anxiety disorder - 7 item (GAD-7) questionnaire. Increase in score dictates increase in severity. Scale of 0-3

  weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months

• Change in depression severity (PHQ-9)

  Patient Health Questionnaire - 9 item (PHQ-9). Increase in score dictates increase in severity. Scale of 0-3 on each question.

  weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months

• Change in depression severity (QIDS)

  Quick Inventory of Depressive Symptomatology (QIDS). Increase in score dictates increase in severity. Scale of 0-3 on each question

  weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months

• Change in stress severity (DASS-42)

  Depression Anxiety Stress Scale-42 (DASS-42). Increase in score dictates increase in severity. Scale of 0-3 on each question.

  weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months

• Change in quality of life (AQoL-8D)

  Assessment of Quality of Life-8D (AQoL-8D). Increase in score dictates increase in quality of life (improvement). Scale of 0-5 on each question.

  weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months

• Change in resilience (RS-14)

  Resilience Scale-14 (RS-14). Increase in score dictates increase in resilience (improvement). Scale of 0-7 on each question

  weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months

• Change in social anxiety severity (LSAS)

  Liebowitz Social Anxiety Scale (LSAS). Increase in score dictates increase in anxiety severity. Scale of 0-3 on each question.

  weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months

• Change in ADHD severity (ASRS)

  Adult ADHD Self-Report Scale (ASRS). Increase in score dictates increase in ADHD symptom severity. Scale of 0-5 on each question.

  weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months

Study Arms (2)

e-Psychotherapy

EXPERIMENTAL

Participants in the treatment group will receive access to the hub's services which begin with six weeks of online psychoeducation. Participants will be recruited through on-campus flyers, advertisements and wellness-center announcements, media advertisements, expert end-user referrals, and self-referrals. Participants will be excluded if they have active psychosis, acute mania, and/or active suicidal or homicidal ideation, and have received psychoeducation or psychotherapy like that offered by our proposed hub in the past six months. Participants with high disorder severity will be referred to other community resources determined by clinicians and therapists on the research team.

Behavioral: e-Psychotherapy/Psychoeducation

Treatment as Usual

NO INTERVENTION

TAU will consist of medications, regular physician or clinician visits, referrals or consultations that are conducted outside of the current research study.

Interventions

e-Psychotherapy/Psychoeducation BEHAVIORAL

Participants will receive six weekly self-guided psychoeducation sessions. Then, after 6 weeks participants will complete monthly clinical questionnaires for 6 months. Also, participants will begin bi-weekly journaling exercises for 6 months. Based on the journaling entries, if the AI algorithm detects MDD, GAD, SAD or ADHD that requires treatment will make a referral to the diagnosis-specific e-CBT (MDD, GAD, SAD or ADHD). If after 6 months, no referral decision is made by the AI algorithm no extra follow-up will be provided. Once the AI makes a referral recommendation, participants will be placed in a diagnosis-specific e-CBT program specific to the diagnosis determined by the AI algorithm (MDD, GAD, SAD, or ADHD). The asynchronous e-CBT programs will consist of 12 weekly modules and homework. Weekly homework is reviewed by a therapist, who will provide personalized feedback based on the participant's preferred method (i.e., text, video, or audio).

e-Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post-secondary students enrolled in institutions of interest
• the ability to provide informed consent
• the ability to speak and read English
• consistent and reliable access to the internet

You may not qualify if:

• \- N/A

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead

Study Sites (1)

Queen's University, Hotel Dieu Hospital

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Nazanin Alavi, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Aim 1 will assess post-secondary students' current mental health needs, through surveys and focus groups. Aims 2 and 3 will use the findings from the surveys and focus groups to inform the development of 6-week psychoeducation and 12-week diagnosis-specific e-CBT programs. The psychoeducation program will be followed by 6-months of AI-assisted journaling exercises to monitor the student's mental health and determine whether they would benefit from stepping up their care to receive the diagnosis-specific e-CBT program. Aims 4 and 5 will determine the efficacy and cost-effectiveness of the online psychoeducation and diagnosis-specific e-CBT programs by comparing them to treatment as usual. Aims 6 and 7 will use the data to monitor the success and fidelity of the programs using surveys and focus groups.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: May 5, 2022
• Primary Completion: September 1, 2022
• Study Completion: April 6, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Post-study
• Access Criteria: Available upon request to researchers

Locations

CA (1)