Whole Selves User Testing and Feasibility Study

User Testing and Feasibility Study of an Intervention Addressing Young Adults' Experiences With Alcohol and Romantic Relationships

Whole Selves is a novel print and online intervention using motivational interviewing principles and personalized feedback to address young adults' alcohol use and romantic relationship functioning. In this study, the investigators will conduct user testing interviews (online and in-person) with 10 young adults to obtain feedback on the Whole Selves intervention prototype, thereby improving its usability, relevance, and user engagement. The investigators will then conduct a single-arm feasibility study of Whole Selves with 107 young adults in order to (1) assess the intervention's acceptability and potential mechanisms and (2) assess feasibility and parameters for a future randomized trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression, Anxiety; Alcohol Use, Unspecified; Relationship, Social
• Intervention / Treatment: Behavioral: Whole Selves

Detailed Description

This study is a single-arm feasibility study of Whole Selves, an interactive online resource, or intervention, to help transgender/nonbinary young adults reflect on their goals and priorities for their alcohol use and their romantic relationships. Unlike existing alcohol interventions and relationship education programs, Whole Selves is being created in partnership with transgender/nonbinary young adults, and it considers ways that being transgender/nonbinary might affect someone's alcohol use or their romantic relationship experiences. Whole Selves will be based on principles of motivational interviewing, a way of helping people think about changes they might make in certain areas of life (such as their alcohol use). Whole Selves will include stories and videos of transgender/nonbinary people sharing their own experiences with alcohol use and romantic relationships. It will also include interactive activities, such as giving users feedback on how their alcohol use compares to averages for transgender/nonbinary young adults.

In this study, the investigators will ask 107 romantically partnered transgender/nonbinary young adults to use the Whole Selves intervention, and they will collect survey data from participants before and after the intervention. They will use this data to improve the intervention, see whether it seems to work in the ways the investigators expected, and make plans for a future randomized trial that could show whether the intervention is effective in reducing alcohol use, depression, and anxiety.

Participants in this feasibility study will take part remotely, using their own computer or mobile device. They will first have a phone call with someone from the research team to learn more about the study. They will then complete an initial survey about their background, romantic relationship experiences, mental health, and alcohol use. Next, they will use the Whole Selves intervention, which takes about 40 minutes, on their own computer or mobile device. Afterwards, they will fill out a short survey with feedback about Whole Selves. Finally, they will fill out two more surveys about their romantic relationship experiences, mental health, and alcohol use after 30 days and 90 days.

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel R Murchison, PhD MPH; Phone Number: 617-850-2905; Email: grmurch@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Public Health
      • Contact: Gabriel R Murchison, PhD MPH; Phone Number: 617-850-2905; Email: grmurch@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able to read and write in English
• Residency in the United States
• Currently in a romantic relationship that began at least six weeks prior to enrollment

Exclusion Criteria:

• Referral source has generated other suspicious responses
• Submitted within 48 hours of other responses with similar or identical content
• Blank or nonsense response to at least one write-in question
• Email address has pattern common in inauthentic responses (e.g., full name followed by a 3- or 4-digit number, last name followed by first name, or full name that appears unrelated to participant's stated name)
• Reported nonstandard demographic information
• Provided an email address with a domain other than gmail.com
• Via Zoom, displaying a photo ID associated with the reported location (school/employer IDs acceptable)
• Via Zoom, displaying a physical item associated with the reported location, such as a transit pass, library card, or university paraphernalia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Whole Selves; Participants assigned to this arm will receive the Whole Selves intervention and complete assessment surveys at baseline, 30 days, and 90 days.

Behavioral: Whole Selves; Whole Selves is a brief online self-guided intervention addressing transgender/nonbinary young adults' experiences with alcohol use and romantic relationships. The intervention is delivered in a single session of approximately 40 minutes. Whole Selves employs principles of technology-adapted motivational interviewing (e.g., eliciting and strengthening participants' internal reasons for behavior change through interactive activities) as well as personalized feedback on participants' self-reported alcohol use and romantic relationship experiences. The intervention incorporates text and video narratives from transgender/nonbinary people sharing their own experiences with alcohol use and romantic relationships. Content will be tailored based on participants' current alcohol use and romantic relationship experiences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms	Self-report of depression symptoms in the prior 30 days, as measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item questionnaire with each item scored from 0 to 3. Scores can range from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).	Baseline, 30 days, 90 days
Anxiety symptoms	Self-report of generalized anxiety symptoms in the prior 30 days, as measured by the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item instrument with each item scored between 0 and 3 where 0=not at all, and 3= nearly every day. Scores can range from 0 to 21 and are interpreted as-- scores 0-4: Minimal Anxiety, scores 5-9: Mild Anxiety, scores 10-14: Moderate Anxiety, and scores greater than 15: Severe Anxiety.	Baseline, 30 days, 90 days
Alcoholic drinks per week	Average (mean) number of alcoholic drinks per week based on 14-day timeline followback, i.e., retrospective self-report of drinks per day.	Baseline, 30 days, 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative alcohol consequences	Self-report of negative alcohol consequences based on the Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Negative Consequences Short Form. The PROMIS Alcohol Negative Consequences Short Form is a 7-item instrument with each item scored between 1 and 5 where 1=never and 5=almost always. These items are summed to calculate a raw score between 0 and 7, which is then converted to a T-score that indicates how much someone experiences negative consequences from their alcohol use relative to the United States general population. A T-score of 50 indicates that a person reported the same degree of negative alcohol consequences as the average U.S. adult, scores below 50 indicate fewer negative alcohol consequences than the average U.S. adult, and scores above 50 indicate more negative alcohol consequences than the average U.S. adult.	Baseline, 30 days, 90 days
Intimate Personal Violence (IPV) victimization	Measured with the Sexual and Gender Minority adaptation of the Revised Conflict Tactics Scale-Short Form, a 74-item instrument assessing specific forms of aggression (psychological, physical acts, physical injury, and sexual), as well as nonviolent conflict resolution strategies, within romantic partnerships. Each partner's use of each tactic is assessed separately (perpetration; victimization) Each item is scored from 0=Never to 6=More than 20 times. The scoring range varies by tactic, with scores of 0 representing the absence of that tactic in the past month, and higher scores indicating a greater frequency of that tactic in the past month.	Baseline, 30 days, 90 days
Relationship satisfaction	Measured with the Couple Satisfaction Index - 4, a four-item instrument assessing overall satisfaction in a romantic relationship. The response scales vary by item (0=Not at all, 5=Completely for one item; 0=Extremely unhappy, 6=Perfect for two items; and 0=Not at all true, 5=Completely true for one item). Scores range from 0 to 21, with higher scores indicating higher levels of relationship satisfaction and scores below 13.5 indicating marked dissatisfaction.	Baseline, 30 days, 90 days
Heavy drinking days	The number of days during when a participant recalls heavy drinking [having five or more drinks], based on timeline followback, i.e., how many alcoholic drinks a participant recalls having on each specific day.	Baseline, 30 days, 90 days
Component-specific user engagement	This outcome will be assessed based on time spent on each intervention component during user testing.	30 days, 90 days
Participant accrual rate during the feasibility study	Assessed from study data on the number of participants enrolled	30 days, 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cannabis misuse	Measured by the Cannabis Use Disorder Identification Test-Revised (CUDIT-R), an 8-item instrument assessing problematic or harmful cannabis use. The first 7 items have response options ranging from 0=Never to 4=Daily/almost daily, and the final item has response options ranging from 0=Never to 4=Yes, during the past 6 months. Scores have a range of 0 to 32, with scores of 8 or more indicating hazardous cannabis use and scores of 12 or more indicating possible cannabis use disorder.	Baseline, 30 days, 90 days
Past week cannabis use	Measured with the question "How many days of the past week did you use cannabis?" with a definition of cannabis and response options ranging from "1 day" to "7 days."	Baseline, 30 days, 90 days

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Gabriel R Murchison, PhD MPH, Boston University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 25, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Interactive online alcohol education; Interactive online relationship education; Whole Selves intervention; Supportive romantic relationships
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Drinking Behavior; Behavior; Anxiety Disorders; Alcohol Drinking; Depression
• Other Study ID Numbers: H-46467; 4R00AA030601 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No