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Walk With Me for Perinatal Grief

Walk With Me (WWM) for Perinatal Grief

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05318287
Acronym
PeriGrief
Enrollment
52
Registered
2022-04-08
Start date
2021-02-01
Completion date
2023-09-30
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grief, Traumatic Stress, Usability

Brief summary

This research will contribute to therapeutic technology to support bereaved parents who have experienced a perinatal loss. The proposed mobile application would accomplish this objective by providing a series of therapeutic modules to provide parents with tools to normalize their grief and additional coping skills to support the grieving process.

Detailed description

The investigators will develop grief processing and healing activities for bereaved parents, via an iterative formative development process with stakeholder input. The investigators will embed the core intervention components in administrative, provider, and client interfaces which will comprise the prototype Walk with Me (WWM) intervention. The investigators will evaluate its feasibility and initial efficacy of WWM in a within-subjects pre-post design study. The investigators will provide the mobile-based provider component for use by health care professionals (HCPs) who work in the partner hospital. HCPs will have access to training videos and bereaved parent content. After training, the HCPs will recruit 52 bereaved parents. HCPs will obtain consent from bereaved parents who express interest in the study to share their contact information with the research team. Parents who wish to participate will provide consent for their own participation in the study. After consent, parents will complete the baseline survey via the Qualtrics online assessment form and then be provided download access to the WWM prototype. At 4 and 8 weeks, parents will be administered post-treatment surveys. This design will allow the investigators to evaluate baseline to follow-up change in the proposed study outcomes and acceptability of the prototype WWM program. Baseline and post-treatment surveys will measure bereaved parents traumatic stress, grief intensity, grief, grief management self-efficacy, and care experiences. The post-survey questionnaire will contain measures of usability, as well as any difficulties experienced or problems made worse. Demographics will be collected at the baseline assessment. Project staff will follow-up with parents as needed to encourage survey completion in a timely manner.

Interventions

BEHAVIORALWalk with Me

Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving.

Sponsors

Oregon Research Behavioral Intervention Strategies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusions Criteria Focus Groups and Usability Testing (Bereaved Parents) * Experienced a perinatal loss * Have had at least 6 months pass since experiencing the most recent loss * Age 15 and older Efficacy Study (Bereaved Parents) * Bereaved parent who has experienced a perinatal loss within the last two weeks \* Age 15 and older * Have access to technology to view WWM content

Exclusion criteria

\* Non-English speakers are excluded. The WWM program will first be developed in English and its feasibility established.

Design outcomes

Primary

MeasureTime frameDescription
Traumatic Stress - Intrusion SubscaleBaseline (immediately following loss), 4 weeks and 8 weeks post lossImpact of Event Scale-Revised (IES-R) includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs not at all; 1, a little bit; 2, moderately; 3, quite a bit; and 4, extremely. Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Traumatic Stress - Avoidance SubscaleBaseline (immediately following loss), 4 weeks and 8 weeks post lossImpact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs not at all; 1, a little bit; 2, moderately; 3, quite a bit; and 4, extremely. Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Traumatic Stress - Hyperarousal SubscaleBaseline (immediately following loss), 4 weeks and 8 weeks post lossImpact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs not at all; 1, a little bit; 2, moderately; 3, quite a bit; and 4, extremely. Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Grief Intensity - Reality SubscaleBaseline (immediately following loss), 4 weeks and 8 weeks post lossThe Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Grief Intensity - Congruence SubscaleBaseline (immediately following loss), 4 weeks and 8 weeks post lossThe Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Grief Intensity - Ability to Confront Others SubscaleBaseline (immediately following loss), 4 weeks and 8 weeks post lossThe Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Grief Management Self-efficacyBaseline (immediately following loss), 4 weeks and 8 weeks post lossThree items that rate the bereaved parents' confidence in their ability to cope with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help coping. Scores are on a six-point scale (1 to 6) with a mean total score that ranges from 1 to 6. Higher scores indicate greater self-efficacy.
Negative Attitudes on Personal GriefBaseline (immediately following loss), 4 weeks and 8 weeks post loss6 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree) to indicate level of agreement. A means score was computed and could range from 1 to 4. Higher scores indicate more negative experiences.
Difficulties in Emotional Regulation - Nonacceptance of Emotional Response SubscaleBaseline (immediately following loss), 4 weeks and 8 weeks post loss11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions.
Difficulties in Emotional Regulation - Lack of Emotional Response SubscaleBaseline (immediately following loss), 4 weeks and 8 weeks post loss11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions.
UsabilityPost-Treatment (8 weeks post loss)The System Usability Scale is commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert-scale. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores indicate the technology is more usable.
AcceptabilityPost-Treatment (8 weeks post loss)Developed as part of the current study, 7 items were designed to measure the degree, on a 5-point Likert-type scale (1 = strongly or somewhat disagree, 5 = strongly or somewhat agree) to which parents found the program helpful, acceptable, and suited to their needs. A mean score was computed across all items and could range from 1 to 5. Higher scores indicate greater acceptability.
Program Use - Days Using the ProgramAccess to the program through through the study completion which was on average 2-months.Program metrics on the backend of the program were used to track the total number of days the program was used.
Program Use - Modules CompletedAccess to the program through through the study completion which was on average 2-months.Program metrics on the backend of the program were used to track the the total number of modules completed out of the 6 modules.

Countries

United States

Participant flow

Participants by arm

ArmCount
PeriGrief
A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss. Walk with Me: Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving.
52
Total52

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up8

Baseline characteristics

CharacteristicPeriGrief
Age, Continuous31.7 years
STANDARD_DEVIATION 6.2
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Number of times pregnant
1
13 Participants
Number of times pregnant
2
18 Participants
Number of times pregnant
3
12 Participants
Number of times pregnant
4
4 Participants
Number of times pregnant
5 or more
5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
6 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
36 Participants
Relationship Status
Divorced or separated
1 Participants
Relationship Status
Married or domestic partner
45 Participants
Relationship Status
Partnered in a serious relationship
5 Participants
Relationship Status
Single, dating
1 Participants
Sex: Female, Male
Female
52 Participants
Sex: Female, Male
Male
0 Participants
Type of loss experienced - Chemical Pregnancy (i.e., loss before the 5th week)4 Participants
Type of loss experienced - Miscarriage in the first trimester21 Participants
Type of loss experienced - Neonatal loss7 Participants
Type of loss experienced - Stillbirth11 Participants
Type of loss experienced - Termination due to fetal abnormality/viability4 Participants
Type of loss experienced - Tubal or ectopic pregnancy1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 52
other
Total, other adverse events
0 / 52
serious
Total, serious adverse events
0 / 52

Outcome results

Primary

Acceptability

Developed as part of the current study, 7 items were designed to measure the degree, on a 5-point Likert-type scale (1 = strongly or somewhat disagree, 5 = strongly or somewhat agree) to which parents found the program helpful, acceptable, and suited to their needs. A mean score was computed across all items and could range from 1 to 5. Higher scores indicate greater acceptability.

Time frame: Post-Treatment (8 weeks post loss)

ArmMeasureValue (MEAN)Dispersion
PeriGriefAcceptability2.88 units on a scaleStandard Deviation 0.29
Primary

Difficulties in Emotional Regulation - Lack of Emotional Response Subscale

11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

Population: There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefDifficulties in Emotional Regulation - Lack of Emotional Response SubscalePretest2.32 units on a scaleStandard Deviation 0.77
PeriGriefDifficulties in Emotional Regulation - Lack of Emotional Response Subscale4-weeks2.38 units on a scaleStandard Deviation 0.85
PeriGriefDifficulties in Emotional Regulation - Lack of Emotional Response Subscale8-weeks2.20 units on a scaleStandard Deviation 0.79
p-value: 0.194t-test, 2 sided
Primary

Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale

11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

Population: There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefDifficulties in Emotional Regulation - Nonacceptance of Emotional Response SubscalePretest2.25 units on a scaleStandard Deviation 1.19
PeriGriefDifficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale4 weeks2.35 units on a scaleStandard Deviation 0.93
PeriGriefDifficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale8 weeks2.08 units on a scaleStandard Deviation 0.95
p-value: 0.403t-test, 2 sided
Primary

Grief Intensity - Ability to Confront Others Subscale

The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefGrief Intensity - Ability to Confront Others SubscalePretest2.61 units on a scaleStandard Deviation 0.89
PeriGriefGrief Intensity - Ability to Confront Others Subscale4-weeks2.71 units on a scaleStandard Deviation 0.73
PeriGriefGrief Intensity - Ability to Confront Others Subscale8-weeks2.55 units on a scaleStandard Deviation 0.8
p-value: 0.347t-test, 2 sided
Primary

Grief Intensity - Congruence Subscale

The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefGrief Intensity - Congruence SubscalePretest2.48 units on a scaleStandard Deviation 0.6
PeriGriefGrief Intensity - Congruence Subscale4-weeks2.59 units on a scaleStandard Deviation 0.59
PeriGriefGrief Intensity - Congruence Subscale8-weeks2.66 units on a scaleStandard Deviation 0.58
p-value: 0.012t-test, 2 sided
Primary

Grief Intensity - Reality Subscale

The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

Population: There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefGrief Intensity - Reality SubscalePretest3.39 units on a scaleStandard Deviation 0.57
PeriGriefGrief Intensity - Reality Subscale4-weeks3.41 units on a scaleStandard Deviation 0.59
PeriGriefGrief Intensity - Reality Subscale8-weeks3.51 units on a scaleStandard Deviation 0.6
p-value: 0.167t-test, 2 sided
Primary

Grief Management Self-efficacy

Three items that rate the bereaved parents' confidence in their ability to cope with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help coping. Scores are on a six-point scale (1 to 6) with a mean total score that ranges from 1 to 6. Higher scores indicate greater self-efficacy.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefGrief Management Self-efficacyPretest4.26 units on a scaleStandard Deviation 0.94
PeriGriefGrief Management Self-efficacy4-weeks4.63 units on a scaleStandard Deviation 0.91
PeriGriefGrief Management Self-efficacy8-weeks4.66 units on a scaleStandard Deviation 1
p-value: 0.007t-test, 2 sided
Primary

Negative Attitudes on Personal Grief

6 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree) to indicate level of agreement. A means score was computed and could range from 1 to 4. Higher scores indicate more negative experiences.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

Population: There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefNegative Attitudes on Personal GriefPretest3.88 units on a scaleStandard Deviation 1.33
PeriGriefNegative Attitudes on Personal Grief4-weeks3.59 units on a scaleStandard Deviation 1.22
PeriGriefNegative Attitudes on Personal Grief8-weeks3.21 units on a scaleStandard Deviation 1.19
p-value: 0.001t-test, 2 sided
Primary

Program Use - Days Using the Program

Program metrics on the backend of the program were used to track the total number of days the program was used.

Time frame: Access to the program through through the study completion which was on average 2-months.

ArmMeasureValue (MEAN)Dispersion
PeriGriefProgram Use - Days Using the Program21.40 daysStandard Deviation 23.39
Primary

Program Use - Modules Completed

Program metrics on the backend of the program were used to track the the total number of modules completed out of the 6 modules.

Time frame: Access to the program through through the study completion which was on average 2-months.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
PeriGriefProgram Use - Modules CompletedDid not complete any modules4 Participants
PeriGriefProgram Use - Modules CompletedCompleted one module10 Participants
PeriGriefProgram Use - Modules CompletedCompleted two modules9 Participants
PeriGriefProgram Use - Modules CompletedCompleted three modules6 Participants
PeriGriefProgram Use - Modules CompletedCompleted four modules1 Participants
PeriGriefProgram Use - Modules CompletedCompleted five modules3 Participants
PeriGriefProgram Use - Modules CompletedCompleted all six modules8 Participants
Primary

Traumatic Stress - Avoidance Subscale

Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs not at all; 1, a little bit; 2, moderately; 3, quite a bit; and 4, extremely. Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

Population: There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefTraumatic Stress - Avoidance SubscalePretest1.61 units on a scaleStandard Deviation 0.93
PeriGriefTraumatic Stress - Avoidance Subscale4-weeks1.44 units on a scaleStandard Deviation 0.94
PeriGriefTraumatic Stress - Avoidance Subscale8-weeks1.23 units on a scaleStandard Deviation 0.9
p-value: 0.01t-test, 2 sided
Primary

Traumatic Stress - Hyperarousal Subscale

Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs not at all; 1, a little bit; 2, moderately; 3, quite a bit; and 4, extremely. Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

Population: There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefTraumatic Stress - Hyperarousal SubscalePretest1.61 units on a scaleStandard Deviation 1.03
PeriGriefTraumatic Stress - Hyperarousal Subscale4-weeks1.53 units on a scaleStandard Deviation 1.04
PeriGriefTraumatic Stress - Hyperarousal Subscale8-weeks1.31 units on a scaleStandard Deviation 1.01
p-value: 0.16t-test, 2 sided
Primary

Traumatic Stress - Intrusion Subscale

Impact of Event Scale-Revised (IES-R) includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs not at all; 1, a little bit; 2, moderately; 3, quite a bit; and 4, extremely. Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.

Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss

Population: There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PeriGriefTraumatic Stress - Intrusion SubscalePretest2.17 units on a scaleStandard Deviation 0.92
PeriGriefTraumatic Stress - Intrusion Subscale4-weeks1.93 units on a scaleStandard Deviation 0.9
PeriGriefTraumatic Stress - Intrusion Subscale8-weeks1.32 units on a scaleStandard Deviation 1.01
p-value: 0.083t-test, 2 sided
Primary

Usability

The System Usability Scale is commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert-scale. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores indicate the technology is more usable.

Time frame: Post-Treatment (8 weeks post loss)

ArmMeasureValue (MEAN)Dispersion
PeriGriefUsability74.4 units on a scaleStandard Deviation 13.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026