Whole Selves User Testing and Feasibility Study

NCT06392542 | Not Yet Recruiting

• 2 other identifiers: H-464674R00AA030601
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use, Unspecified; Relationship, Social; Depression, Anxiety

Keywords

Interactive online alcohol education; Interactive online relationship education; Whole Selves intervention; Supportive romantic relationships

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (6)

• Heavy drinking days

  Baseline, 30 days, 90 days

• Negative alcohol consequences

  Baseline, 30 days, 90 days

• Intimate Personal Violence (IPV) victimization

  Baseline, 30 days, 90 days

• Relationship satisfaction

  Baseline, 30 days, 90 days

• Component-specific user engagement

  30 days, 90 days

Study Arms (1)

Whole Selves

EXPERIMENTAL

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

Interventions

Whole Selves BEHAVIORAL

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.

Whole Selves

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Gabriel R Murchison, PhD MPH

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel R Murchison, PhD MPH

CONTACT

617-850-2905; grmurch@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm feasibility trial

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)