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Completed

NCT Number: NCT06375876

Single Session Intervention to Promote Hope

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.

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Key information

Conditions

Domestic Violence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Consultation Center at Yale

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility assessed by percent enrolled

    Time frame: up to one month

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

  2. Feasibility assessed by time to complete

    Time frame: up to one month

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

  3. Feasibility assessed by post-intervention survey/process supplement

    Time frame: up to one month

    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.

  4. Acceptability/likability assessed using the Program Feeback Scale

    Time frame: up to one month

    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.

  5. Safety assessed using end of study survey

    Time frame: up to one month

    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.

  6. Change in Hope assessed using Herth Hope Index

    Time frame: baseline (pre intervention) and up to one month (post intervention)

    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

  7. Change in Hope assessed using Trait Hope Scale

    Time frame: baseline (pre intervention) and up to one month (post intervention)

    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

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

    Time frame: baseline (pre intervention) and up to one month (post intervention)

    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.

Secondary outcomes

  1. Change in Self-worth

    Time frame: baseline (pre intervention) and up to one month (post intervention)

    Change in self-worth will be assessed with daily data using 1 item from the self-esteem/self-efficacy subscale of the Making Decisions and Empowerment Measure. The item is rated on a scale from 0 (Strongly Disagree) to 5 (Strongly Agree).

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

    Time frame: baseline (pre intervention) and up to one month (post intervention)

    Changes in empowerment will be assessed with daily data using 2 items from the Personal Progress Scale-Revised. Items are rated on a scale from 0 (Strongly Disagree) to 5 (Strongly Agree). The two items are summed; Scores range from 0-10 with higher scores indicating higher levels of empowerment

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

    Time frame: baseline (pre intervention) and up to one month (post intervention)

    Changes in emotional wellbeing will be assessed with daily data using the PHQ-2. The two items are rated on a scale from 0 (Not at all) to 3 (Nearly the entire day) and summed, with scores ranging from 0-6, with higher scores indicating higher prevalence depressive symptoms.

  4. Change in Emotional wellbeing measured by the State Joy Scale

    Time frame: baseline (pre intervention) and up to one month (post intervention)

    Changes in emotional wellbeing will be assessed with daily data using 1 item from the State Joy Scale. The item is rated on a on a scale from 0 (Not at all) to 3 (Nearly the entire day) with higher values indicating higher prevalence of joy.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Center for Family Justice
  • Connecticut Coalition Against Domestic Violence
  • Office on Violence Against Women (OVW)

Registry information

Official study title

Hope as a Path to Healing: Developing a Single-Session Intervention for Women Who Experience Intimate Partner Violence

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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