Behavioral Intervention for Stress

Overseen By Athena DF Sherman, PhD, PHN, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Mental health treatment, others

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

Compensation: Varies

Number of Visits: 9

Duration: 7 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and test a program to help transgender women manage stress from ongoing stigma, which can lead to symptoms of psychological distress such as anxiety and depression. The program, called the Adaptive Intervention Approach, offers educational content on recognizing distress, coping strategies, and building supportive social networks. It suits English-speaking transgender women assigned male at birth who are not currently in mental health treatment or living in a controlled environment. As an unphased trial, this study allows participants to contribute to pioneering research that could significantly enhance mental health support for transgender women.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral intervention is safe?

Research shows that stress-management and coping strategies are generally safe and well-tolerated. Studies have found that these methods can greatly reduce stress, anxiety, and depression while improving quality of life without causing major side effects. This trial focuses on a new approach to help transgender women manage psychological distress.

Although this specific method is new, past research on similar strategies suggests they work well and carry a low risk of negative effects. Participants often report feeling better and more resilient after these interventions. This evidence strongly supports the safety and potential benefits of joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adaptive Intervention Approach for stress because it offers a personalized strategy that targets both individual resilience and community support. Unlike traditional treatments that might focus solely on medication or generic therapy, this approach uses the Transgender Resilience Intervention Model (TRIM) to tailor educational content specifically for identifying and managing psychological distress. It emphasizes building coping skills and fostering social connections, which can be particularly empowering for individuals seeking a comprehensive way to handle stress. This dual focus on personal and social resilience sets it apart from standard care options, which often do not integrate community-based support as a key component.

What evidence suggests that this behavioral intervention is effective for reducing psychological distress among transgender women?

Research has shown that stress-management techniques and cognitive-behavioral therapy effectively reduce anxiety and increase hope. These treatments can significantly lower anxiety, depression, and stress while improving quality of life. Additionally, online cognitive-behavioral programs have effectively reduced stress, anxiety, and depression in adults. This trial will test an intervention using educational content informed by the Transgender Resilience Intervention Model (TRIM) and adapted from Seeking Safety. This approach aims to reduce psychological distress in transgender women by building individual and group resilience through coping strategies and social support. ^{1 2 4 6 7}

Who Is on the Research Team?

Athena DF Sherman, PhD, PHN, RN

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for Black or mixed-race individuals including Black, assigned male at birth but now identify as women/transgender feminine/female, aged 18+, who experience psychological distress. They must speak/read English and have certain scores on PTSD or depression scales indicating stress.

Inclusion Criteria

I identify as a woman, transgender feminine, or female.

I was assigned male at birth.

Ability to speak/read English

Exclusion Criteria

Enrolled in mental health treatment or a controlled consequential environment (e.g. mental health transitional living environment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of a culturally informed community-based intervention with guidance from community members via focus groups and theater testing

4 weeks

4 virtual focus group sessions

Treatment

Participants receive a hybrid intervention with 3 in-person sessions and 4 online sessions to manage psychological distress symptoms

7 weeks

3 in-person visits, 4 virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Assessments at 2 weeks and 3 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Intervention Approach

Trial Overview

The study is testing a community-based intervention designed with input from focus groups to help reduce the impact of chronic stigma on mental health symptoms like PTSD and depression in transgender women.

How Is the Trial Designed?

Group I: intervention educational content Experimental Treatment 1 Intervention

The base intervention design will contain educational content informed by the Transgender Resilience Intervention Model (TRIM) and adapted from Seeking Safety specific to a) identifying symptoms of psychological distress, b) managing symptoms via coping (individual resilience), and c) developing a social network and using social support/community connection (group resilience).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Adaptive interventions allow for personalized treatment by adjusting the dosage of prevention or treatment components based on individual needs and characteristics, making them more aligned with real-world clinical practices.

The paper provides a conceptual framework for designing and evaluating adaptive interventions, highlighting the importance of tailoring variables and identifying areas for further research to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A conceptual framework for adaptive preventive interventions. Collins, LM., Murphy, SA., Bierman, KL.[2022]

In a pilot study involving 30 participants in a misdemeanor drug court, those receiving an adaptive intervention had higher graduation rates and resolved their cases nearly 4 months faster than those in the standard program.

Participants in the adaptive intervention reported similar levels of satisfaction and therapeutic alliance with their counselors, indicating that the intervention is both effective and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive interventions may optimize outcomes in drug courts: a pilot study. Marlowe, DB., Festinger, DS., Arabia, PL., et al.[2021]

In a study involving 160 individuals with alcohol use disorder (AUD), those who received a combination of motivational interviewing (MI) and behavioral self-control therapy (BSCT) showed the greatest reductions in drinking, indicating the effectiveness of tailored interventions.

Participants who received MI followed by BSCT had the best outcomes, suggesting that a stepped care approach with prolonged treatment and multiple sessions can optimize recovery from AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An efficacy trial of adaptive interventions for alcohol use disorder. Morgenstern, J., Kuerbis, A., Shao, S., et al.[2022]

Adaptive intervention (AI) is a flexible approach that allows for real-time adjustments to treatment strategies based on individual needs, enhancing the effectiveness of health behavior interventions.

The study outlines essential components of AI, such as intervention outcomes and decision points, which can guide future research and development in personalized health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research Progress of Adaptive Intervention]. Li, SN., Ni, XS., Hu, WY., et al.[2021]

Adaptive treatment strategies (ATSs) are becoming more popular for managing chronic conditions, and sequential multiple assignment randomized trials (SMARTs) are an effective way to study these individualized approaches.

This paper introduces a Bayesian framework for calculating sample sizes in SMARTs, which provides more accurate estimates by reducing reliance on assumptions and incorporating prior knowledge, as demonstrated in a simulation study for a stress management intervention in cardiovascular disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bayesian sample size calculations for comparing two strategies in SMART studies. Turchetta, A., Moodie, EEM., Stephens, DA., et al.[2023]

Recent studies show that adaptive behavioral interventions can effectively reduce sedentary behavior and increase physical activity in overweight or obese adults through timely prompts, although most studies have been feasibility trials.

A stepped-down weight management intervention did not lead to greater weight loss compared to traditional fixed interventions, indicating that more research is needed to optimize adaptive strategies for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive Intervention Designs to Promote Behavioral Change in Adults: What Is the Evidence? Miller, CK.[2020]

Adaptive interventions, which adjust treatment based on individual responses and preferences, are essential for optimizing patient outcomes and minimizing unnecessary treatment burdens.

The Sequential Multiple Assignment Randomized Trial (SMART) design offers a robust framework for developing and refining these adaptive interventions, as demonstrated in studies like the one involving Naltrexone, providing valuable data for personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A "SMART" design for building individualized treatment sequences. Lei, H., Nahum-Shani, I., Lynch, K., et al.[2023]

Adaptive interventions allow for personalized treatment options that can change over time based on individual needs, potentially improving long-term effectiveness compared to traditional fixed interventions.

The sequential multiple assignment randomized trial (SMART) design is proposed as a valuable method for developing and evaluating adaptive interventions, offering a structured way to analyze how different treatment strategies can be optimized for individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental design and primary data analysis methods for comparing adaptive interventions. Nahum-Shani, I., Qian, M., Almirall, D., et al.[2021]

Adaptive interventions, which tailor treatment to individual needs over time, are gaining attention in health research, and the sequential, multiple assignment, randomized trial (SMART) design is a key method for developing these interventions.

This article introduces a new methodology for analyzing longitudinal data from SMART studies, allowing researchers to compare the effectiveness of different adaptive interventions beyond just end-of-study outcomes, as demonstrated in a study focused on engaging individuals with alcohol and cocaine dependence in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMART longitudinal analysis: A tutorial for using repeated outcome measures from SMART studies to compare adaptive interventions. Nahum-Shani, I., Almirall, D., Yap, JRT., et al.[2020]

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Stress-management-based cognitive-behavioral treatments were effective on the level of anxiety sensitivity and hope (p <0.016), however, it had no significant ...

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Psychosocial interventions applied to parents have significant effects on reducing anxiety, depression, and stress and improving the quality of life.

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This study aims to systematically review the literature to describe the landscape of existing JITAIs for behavioral health at any stage of intervention ...

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This study aims to identify key tailoring variables that influence momentary engagement in digital stress reduction microinterventions to inform the design of ...