Single Session Intervention to Promote Hope

NCT06375876 | Completed

• 2 other identifiers: 200003417315JOVW-22-GG-04755-STOP
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Domestic Violence

Keywords

Intimate Partner Violence (IPV)

Outcome Measures

Primary Outcomes (8)

• Feasibility assessed by percent enrolled

  The percent of women enrolled in the study who complete the SSI and individual SSI components.

  up to one month

• Feasibility assessed by time to complete

  How long it took a participant to complete the intervention (in minutes), and if it was done in more than one setting.

  up to one month

• Feasibility assessed by post-intervention survey/process supplement

  Feasibility will also be assessed in the post-intervention survey/process supplement by asking women 1) where they completed the program, 2) if they listened to the program's read aloud options, and 3) an open-response question about factors that influenced where and when they completed the program since little is known about factors that participation in an intervention of this nature.

  up to one month

• Acceptability/likability assessed using the Program Feeback Scale

  The Program Feedback Scale asks participant to rate seven statements regarding intervention acceptability and feasibility; it also includes open-response items that invite participants to share what they liked and/or would change about the intervention. The seven statements are rated from 0 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 0 to 36, with higher scores indicating a more positive evaluation.

  up to one month

• Safety assessed using end of study survey

  Participants will be asked if completing the intervention caused any problems for them and their partner that made them feel unsafe; participants responding in the affirmative will be asked to elaborate in a follow-up open-response question.

  up to one month

• Change in Hope assessed using Herth Hope Index

  Change in hope will be assessed with daily data using 5 items from the HHI that measure 3 dimensions of hope: 2 items from the temporality and future/cognitive-temporal subscale, 1 item from the positive readiness and expectancy subscale, and 2 items from the interconnectedness subscale. Items are rated from 0 (Strongly Disagree) to 5 (Strongly Agree) with higher values indicating more hope

  baseline (pre intervention) and up to one month (post intervention)

• Change in Hope assessed using Trait Hope Scale

  Change in hope will be assessed with daily data using 2 items from the Trait Hope Scale; 1 item from the agency subscale and 1 item from the pathway subscale. Items are rated from 0 (Strongly Disagree) to 5 (Strongly Agree), with higher values indicating more hope

  baseline (pre intervention) and up to one month (post intervention)

• Change in Hope assessed using Beck Hopelessness Scale (single item)

  Hopelessness will be assessed with daily data using 1 item from the Beck Hopelessness Scale. The item is rated on a scale from 0 'Strongly disagree' to 5 'Strongly agree' with higher values indicating higher levels of hopelessness.

  baseline (pre intervention) and up to one month (post intervention)

Secondary Outcomes (4)

• Change in Self-worth

  baseline (pre intervention) and up to one month (post intervention)

• Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R)

  baseline (pre intervention) and up to one month (post intervention)

• Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2)

  baseline (pre intervention) and up to one month (post intervention)

• Change in Emotional wellbeing measured by the State Joy Scale

  baseline (pre intervention) and up to one month (post intervention)

Study Arms (1)

Single-Session Intervention to Promote Hope

EXPERIMENTAL

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

Behavioral: Single-session intervention (SSI)

Interventions

Single-session intervention (SSI) 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.

Single-Session Intervention to Promote Hope

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Office on Violence Against Women (OVW): collaborator
• Center for Family Justice: collaborator
• Connecticut Coalition Against Domestic Violence: collaborator

Study Sites (1)

The Consultation Center at Yale

New Haven, Connecticut, 06511, United States

Location

Study Officials

• Tami Sullivan, PhD

  Department of Psychiatry, Yale School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: May 7, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)