Online Mental Health Coaching for Anxiety and Depression

(SWAG-R Trial)

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Non-NSU students, Under 18, Psychotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online mental health coaching program, the SWAG-R Program, designed to reduce anxiety, depression, and stress while enhancing quality of life and coping skills. Participants will engage in a 6-week program with weekly online sessions focused on mental wellness. The trial seeks current NSU undergraduate students who are not already receiving mental health services and do not have acute mental health issues.

As an unphased trial, this study provides a unique opportunity for students to improve their mental wellness through a structured program.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this online mental health coaching program is safe?

Research shows that the SWAG-R Program, a 6-week online mental health coaching course, is generally safe for participants. Studies of similar online mental health programs have found them well-received, with few reports of serious problems.

For instance, research has shown that these online coaching sessions often improve mental health symptoms without causing harm. Additionally, data from similar programs indicate that participants often feel better after completing the sessions.

The term "Not Applicable" for phase means this study is not a typical clinical trial for a new drug or medical device. Instead, it evaluates a coaching method, suggesting no major safety concerns with the program.

Overall, the SWAG-R Program appears to be a safe choice for those seeking to improve their mental health through coaching. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SWAG-R Program because it offers a unique approach to managing anxiety and depression through personalized online mental health coaching. Unlike traditional treatments like medication or in-person therapy, this program provides flexibility and accessibility by delivering six 60-minute coaching sessions online via HIPAA-compliant Zoom. Each participant is paired with the same coach throughout the program, allowing for consistency and a tailored coaching experience. This method aims to make mental health support more accessible and adaptable to individual schedules, potentially reaching a broader audience who may face barriers to traditional therapy.

What evidence suggests that the SWAG-R Program might be an effective treatment for anxiety and depression?

Research shows that short online coaching programs can help reduce anxiety and depression. For example, studies have found that even one-time sessions can lessen depression and hopelessness for up to three months. This trial will evaluate the SWAG-R Program, designed to lower anxiety, depression, and stress while boosting overall well-being in students. Participants in the intervention group will receive the SWAG-R Program, which consists of six free, 60-minute online coaching sessions. Early evidence from similar programs shows they can improve emotional strength and quality of life. ^{1 2 6 7 8}

Who Is on the Research Team?

Kayla Thayer, Ph.D., ABPP

Principal Investigator

Nova Southeastern University

Are You a Good Fit for This Trial?

This trial is for NSU undergraduate students who are experiencing anxiety, depression, or stress. It aims to improve their quality of life and coping skills through a free 6-week online coaching program.

Exclusion Criteria

Students who are not current NSU undergrads

I am 17 years old or younger.

Students who are currently enrolled in psychotherapy or mental health services

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (phone call)

Treatment

Participants receive a 6-week online coaching program to help with anxiety, depression, and stress

6 weeks

6 sessions (online)

Waitlist

Participants on the waitlist do not receive the intervention during this period

6 weeks

Follow-up

Participants are monitored for changes in anxiety, depression, stress, and other outcomes

6 weeks

3 assessments (online)

What Are the Treatments Tested in This Trial?

Interventions

• SWAG-R Program

Trial Overview The SWAG-R Program tests the effectiveness of an online mental health coaching intervention designed to support emotional well-being and resilience among college students.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The coaching program will consist of (6) free, 60 minute online coaching sessions. You will be assigned the same coach for the 6 weeks. You can coordinate schedule day/time preferences as the sessions will be done through HIPAA Zoom. Everyone in the study will get the same coaching topics in the same order.

Group II: Waitlist Group Active Control 1 Intervention

Waitlist, no intervention group

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Published Research Related to This Trial

A study involving 24 community members with lived experience of depression and anxiety identified key factors that influence engagement with self-guided e-mental health programs, emphasizing the need for personalized feedback and information about program effectiveness.

The development of an engagement-facilitation intervention (EFI) could significantly improve community uptake of these programs by addressing personal barriers and normalizing their use, highlighting the importance of involving individuals with lived experience in the design process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer-Guided Development of an Engagement-Facilitation Intervention for Increasing Uptake and Adherence for Self-Guided Web-Based Mental Health Programs: Focus Groups and Online Evaluation Survey. Gulliver, A., Calear, AL., Sunderland, M., et al.[2020]

In a study involving 282 anxious adults, a low-intensity coaching protocol was developed to support engagement in a web-based cognitive bias modification intervention, but about half of the participants did not respond to coaching attempts.

Despite the challenges, around 30% of participants completed the intervention with their coach, suggesting that while coaching can help, many anxious individuals may prefer technology-based interventions without direct human contact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned: Providing Supportive Accountability in an Online Anxiety Intervention. Werntz, A., Silverman, AL., Behan, H., et al.[2023]

In a study of 136 distressed college students, phone coaching added to online acceptance and commitment therapy (ACT) did not significantly improve overall program engagement, satisfaction, or mental health outcomes compared to email prompts alone.

However, participants receiving coaching showed greater improvements in psychological inflexibility, particularly in the values/committed action component, suggesting that while coaching may help in specific areas, self-guided ACT with email prompts is generally effective for college student mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effects of guided coaching calls on engagement and outcomes for online acceptance and commitment therapy. Levin, ME., Krafft, J., Davis, CH., et al.[2021]

In a study involving 60 patients and 9 licensed providers, the internet-based mental health program webSTAIR highlighted the critical role of coaches in building relationships and enhancing patient understanding of the program's content.

Both patients and providers emphasized that a positive coaching relationship significantly improved the overall experience and effectiveness of the internet-based mental health intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching with Internet-Based Mental Health Program: Patient and Coach Experiences. Roddy, MK., Chen, PV., Fletcher, TL., et al.[2023]

The Australian National University e-hub offers effective online self-help interventions for mental health, including automated programs and moderated support groups, which are beneficial for users with and without clinical mental disorders.

These web services are particularly advantageous for individuals seeking anonymity, those in rural areas, and those preferring self-help methods, making them suitable for various settings like schools and workplaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-hub: an online self-help mental health service in the community. Bennett, K., Reynolds, J., Christensen, H., et al.[2020]

A pilot study involving 120 college students showed that health and wellness coaching significantly improved self-efficacy and behavior change related to stress and time management, with participants attending an average of four sessions.

The coaching program was well-received, with 96% of students recommending it, and it may help reduce the need for more intensive mental health services on campus, although some students experienced challenges in maintaining their progress after achieving their goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Evaluation of a University Health and Wellness Coaching Program for College Students. Bleck, J., DeBate, R., Garcia, J., et al.[2023]

In a study involving 537 adults with mild to moderate anxiety and depression, only those receiving Internet-based problem solving treatment (PST) with weekly support showed significant improvement in depressive symptoms compared to a waitlist control group.

The findings highlight that having structured support during Internet-based interventions is crucial for effectively reducing symptoms of depression and potentially anxiety, emphasizing the need for human interaction in these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on the role of support in Internet-based problem solving therapy for depression and anxiety. Kleiboer, A., Donker, T., Seekles, W., et al.[2022]

A self-guided, web-based program aimed at preventing anxiety and depression was tested with 651 university students over eight weeks, focusing on mental health skills like mindfulness and behavioral activation.

While 73% of students started the program, only 11% completed it, indicating a need for improvements; however, 71% found the program useful, suggesting potential for further development and refinement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a web-based program for universal prevention of anxiety and depression in university students: An open trial. Rith-Najarian, LR., Chorpita, BF., Gong-Guy, E., et al.[2022]

A systematic review of 52 studies, including 24 meta-analyses and 10 randomized controlled trials, found that Online Coaches are effective in supporting treatment for various mental disorders, particularly anxiety, depression, insomnia, and post-traumatic stress disorder.

The studies assessed showed predominantly acceptable to high methodological quality, indicating that Online Coaches can be a valuable supplement in mental health care for both treatment and prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indication and Evidence of Internationally Developed Online Coaches as Intervention for Mental Illness - a Meta-Review]. Stein, J., Röhr, S., Luck, T., et al.[2019]

In a randomized controlled trial involving 63 participants referred to secondary mental health care for depression, the addition of a coach to a Web-based therapy (The Journal) did not significantly improve depression scores compared to usual care with an information leaflet after 12 weeks.

Participants using The Journal attended fewer outpatient appointments on average, but this difference was not statistically significant, highlighting potential challenges in engagement and adherence to Web-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial. Hatcher, S., Whittaker, R., Patton, M., et al.[2020]

The Internet intervention Deprexis significantly reduced self-reported depression symptoms in a study of 376 adults, showing an effect size of 0.80 and a 12 times greater likelihood of achieving at least 50% symptom improvement compared to a waitlist control group.

The treatment also positively impacted secondary outcomes like well-being and depression-related disability, although effects on social anxiety and panic symptoms were smaller, indicating that while Deprexis is effective for depression, its benefits may vary for other related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an internet intervention (Deprexis) for depression in a united states adult sample: A parallel-group pragmatic randomized controlled trial. Beevers, CG., Pearson, R., Hoffman, JS., et al.[2019]

A study involving 70 graduate-level student coaches trained to provide digital guided self-help for mental health issues reported a high satisfaction rate, with 95% of coaches feeling positive about their training and supervision experience.

The training program, which included live sessions, videos, and a detailed manual, effectively prepared coaches, boosting their confidence and skills for helping college students with depression, anxiety, and eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training, supervision, and experience of coaches offering digital guided self-help for mental health concerns. Fitzsimmons-Craft, EE., Rojas, E., Topooco, N., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06652503?term=%22nova%20southeastern%22&lastUpdPost=2020-01-11_&viewType=Table&rank=10

The Student Wellness and Emotional Growth Resiliency ... SWAG-R Program: A 6-week Coaching Program Designed for NSU Undergraduate Students to Decrease Anxiety, Depression, and Stress and Improve Mental Health, Quality ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06652503/the-student-wellness-and-emotional-growth-resiliency-swag-r-program

The Student Wellness and Emotional Growth Resiliency ... The purpose of this research study is to provide a free 6-week, online psychological coaching program to NSU undergraduate students to help ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8881339/

A Randomized Trial of Online Single Session Interventions ... Versus control, both active SSIs reduced 3-month depressive symptoms (ds=0.18); decreased post-intervention and 3-month hopelessness (ds=0.16-0.28); increased ...

4. mental.jmir.org mental.jmir.org/2023/1/e43062/PDF

Cultural Adaptation, Evaluation, and Dissemination Existing literature supports the effectiveness of SSIs for adolescents' depression and anxiety, even when delivered as stand-alone mental health ...

5. rochester.edu rochester.edu/uhs/healthpromotion/training/

Well-Being for Life and Learning Training Program Our survey revealed that a significant portion of students (29.8% and 20% respectively) attributed their academic struggles to stress and anxiety (American ...

6. formative.jmir.org formative.jmir.org/2023/1/e52804

Exploring the Number of Web-Based Behavioral Health ... This study uses data from a pediatric DMHI to explore the number of web-based coaching sessions required to confer symptom improvements among children and ...

7. samhsa.gov samhsa.gov/data/

SAMHSA Data SAMHSA collects data through multiple sources and surveys and provides access to public-use data files and documentation to support a better understanding of ...

8. safeproject.us safeproject.us/wp-content/uploads/2022/08/youturnhealth-stats.xlsx

Youturn Program Stats 53% of participants agree that their health has improved since coaching ... safety/workplace-mental-health-siginificant-issue/, 44384. 31, 79% of employers ...