Single Session Intervention to Promote Hope

NCT ID: NCT06375876

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2026-01-31

Brief Summary

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The purpose of this study is to develop a brief, self-guided single-session intervention (SSI) that targets the development of, or increase in, hope, and pilot test it for the primary outcomes of feasibility, acceptability/likeability, safety, and changes in hope, and the secondary outcomes of self-worth, empowerment, and emotional wellbeing among women experiencing intimate partner violence (IPV). The study will be conducted in 2 stages: intervention development (Intervention Development Stage), and pilot testing the intervention (Pilot Stage). The focus of this registration is the Pilot Stage.

Detailed Description

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This study aims to accomplish two primary objectives: Objective 1 (Intervention Development Stage): Develop a brief, self-guided SSI to enhance hope and in turn, self-worth, empowerment, and emotional wellbeing, and Objective 2 (Pilot Stage): Pilot test the intervention and evaluate the process of implementation and primary outcomes of feasibility, acceptability/likability, and safety; and to assess changes in hope and secondary outcomes of self-worth, empowerment, and emotional wellbeing.

The Pilot Stage will utilize micro-longitudinal methods (i.e., daily self-reports of hope, self-worth, empowerment, and emotional wellbeing for 14 days before and after the intervention) to assess changes in these constructs. Eligible participants will take part in a baseline interview with a member of the research team. Baseline measures will be based on participant self-report and used to characterize the sample and collect data on person-level control variables. Beginning the day after the baseline interview, participants will complete a brief daily survey on their smartphone. On day 15, participants will receive a link to the SSI and be asked to complete it that day; immediately following the SSI, participants will be asked to complete the post-intervention survey/process supplement to aid in the process evaluation. After completion of the SSI, survivors will participate in 14 additional days of daily data collection to establish post-intervention outcome measures.

Conditions

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Domestic Violence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Single-Session Intervention to Promote Hope

A 30-45 minute self-guided intervention delivered in a web browser.

Group Type EXPERIMENTAL

Single-session intervention (SSI)

Intervention Type BEHAVIORAL

The SSI focuses on increasing hope among women who experience IPV using facts about the brain and IPV research, stories from survivors, and writing exercises.

Interventions

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Single-session intervention (SSI)

The SSI focuses on increasing hope among women who experience IPV using facts about the brain and IPV research, stories from survivors, and writing exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Pilot Stage:

* Self-identify as a woman (cis- or trans-gender woman)
* Currently in a relationship of at least 3 months duration in which they have experienced physical IPV by a male partner
* Have a smartphone that is compatible with the MyCap app to be able to participate in daily surveys.

Exclusion Criteria

Pilot Stage:

* Have experienced significant psychiatric instability based on self-reported inpatient psychiatric hospitalization in the past 3 months
* Reports having a conservator of person
* Not comfortable conversing, reading, or writing in English
* Participated in a Listening Session in the development phase of this study.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Office on Violence Against Women (OVW)

UNKNOWN

Sponsor Role collaborator

Center for Family Justice

UNKNOWN

Sponsor Role collaborator

Connecticut Coalition Against Domestic Violence

UNKNOWN

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tami Sullivan, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Yale School of Medicine

Locations

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The Consultation Center at Yale

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tami Sullivan, PhD

Role: CONTACT

203-789-7645

Ashley Clayton, MA

Role: CONTACT

203-623-9830

Facility Contacts

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Ashley Clayton

Role: primary

203-623-9830

Other Identifiers

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15JOVW-22-GG-04755-STOP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000034173

Identifier Type: -

Identifier Source: org_study_id

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