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

Trial Summary

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 data supports the effectiveness of the treatment Adaptive Intervention Approach for stress?

Research shows that adaptive interventions, which adjust treatment based on individual needs, have been effective in improving outcomes in various settings, such as drug courts and diabetes prevention. These interventions help tailor the treatment to each person's progress, potentially making them more effective for managing stress as well. ^{1 2 3 4 5}

Is the Behavioral Intervention for Stress generally safe for humans?

The research articles reviewed do not provide specific safety data for the Behavioral Intervention for Stress or its related adaptive intervention approaches. They focus on the design and efficacy of these interventions rather than safety outcomes. ^{1 2 4 6 7}

How is the Adaptive Intervention Approach treatment for stress different from other treatments?

The Adaptive Intervention Approach is unique because it customizes the type or amount of treatment for each person over time, based on their individual needs and progress. This personalized method aims to improve the effectiveness of the treatment by adjusting it as needed, unlike traditional treatments that are usually fixed and the same for everyone. ^{1 2 4 8 9}

What is the purpose of this trial?

The research objectives of this study are to first, develop a culturally informed community-based intervention with guidance from community members (via focus groups and theater testing) to reduce the effect of chronic stigma exposure on psychological distress symptoms (PTS and depressive symptoms) among transgender women. Second, the research team will conduct a proof-of-concept trial to determine the feasibility and preliminary efficacy of the resulting intervention.

Research Team

Athena DF Sherman, PhD, PHN, RN

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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, 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

A conceptual framework for adaptive preventive interventions. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Adaptive interventions may optimize outcomes in drug courts: a pilot study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

An efficacy trial of adaptive interventions for alcohol use disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A "SMART" design for building individualized treatment sequences. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

SMART longitudinal analysis: A tutorial for using repeated outcome measures from SMART studies to compare adaptive interventions. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Bayesian sample size calculations for comparing two strategies in SMART studies. [2023]

8. China pubmed.ncbi.nlm.nih.gov

[Research Progress of Adaptive Intervention]. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Experimental design and primary data analysis methods for comparing adaptive interventions. [2021]