Domestic ViolenceNCT06375876
Single Session Intervention to Promote Hope
A study testing Single-session intervention (SSI) in people with Domestic Violence, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Single-session intervention (SSI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Consultation Center at Yale
New Haven, Connecticut, 06511
About this study
Official title: Hope as a Path to Healing: Developing a Single-Session Intervention for Women Who Experience Intimate Partner Violence
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.
Read the detailed description
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
- Domestic Violence
- Being tested
- Single-session intervention (SSI)
- Keywords
- Intimate Partner Violence (IPV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-session intervention (SSI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Session Intervention to Promote Hope | Experimental | A 30-45 minute self-guided intervention delivered in a web browser. Receives: Behavioral: Single-session intervention (SSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by percent enrolled
The percent of women enrolled in the study who complete the SSI and individual SSI components.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline (pre intervention) and up to one month (post intervention)
Secondary outcomes (4)
Change in Self-worth
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).
Measured: baseline (pre intervention) and up to one month (post intervention)
Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R)
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
Measured: baseline (pre intervention) and up to one month (post intervention)
Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2)
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.
Measured: baseline (pre intervention) and up to one month (post intervention)
Change in Emotional wellbeing measured by the State Joy Scale
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.
Measured: baseline (pre intervention) and up to one month (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start7 May 2024
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Office on Violence Against Women (OVW), Center for Family Justice, Connecticut Coalition Against Domestic Violence
- Responsible party
- Sponsor
- Investigators
- Tami Sullivan, PhD, Principal investigator, Department of Psychiatry, Yale School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375876
- Sponsor's protocol ID
- 2000034173
- Other IDs
- 15JOVW-22-GG-04755-STOP
- Status last verified
- Mar 2026
- First submitted
- 16 Apr 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be archived 90 days before the end of the project period with the National Archive of Criminal Justice Data (NACJD) at the University of Michigan. Investigators will share data collection instruments and analytic code.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hope as a Path to Healing: Developing a Single-Session Intervention for Women Who Experience Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT06375876
- Acronym / sponsor ID
- 2000034173
- Conditions
- Domestic Violence
- Keywords
- Intimate Partner Violence (IPV)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Office on Violence Against Women (OVW), Center for Family Justice, Connecticut Coalition Against Domestic Violence
- Study start
- 7 May 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Session Intervention to Promote Hope | Experimental | Behavioral: Single-session intervention (SSI)A 30-45 minute self-guided intervention delivered in a web browser. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Single-Session Intervention to Promote Hope |
Primary outcome
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.
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.
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.
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.
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.
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
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
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.
4 secondary outcomes
Change in Self-worth
Time frame: baseline (pre intervention) and up to one month (post intervention)
Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R)
Time frame: baseline (pre intervention) and up to one month (post intervention)
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)
Change in Emotional wellbeing measured by the State Joy Scale
Time frame: baseline (pre intervention) and up to one month (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be archived 90 days before the end of the project period with the National Archive of Criminal Justice Data (NACJD) at the University of Michigan. Investigators will share data collection instruments and analytic code.
Related trials for Domestic Violence
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Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tami Sullivan, PhD principal investigator
Department of Psychiatry, Yale School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-session intervention (SSI) in people with Domestic Violence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by percent enrolled (time frame: up to one month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.