Trial Outcomes & Findings for Walk With Me for Perinatal Grief (NCT NCT05318287)

NCT ID: NCT05318287

Last Updated: 2025-06-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
• Results posted on: 2025-06-04

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	52
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure

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.

Overall Study Lost to Follow-up

8

Baseline Characteristics

Walk With Me for Perinatal Grief

Baseline characteristics by cohort

Measure	PeriGrief n=52 Participants 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.
Age, Continuous	31.7 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Relationship Status Single, dating	1 Participants n=5 Participants
Relationship Status Married or domestic partner	45 Participants n=5 Participants
Relationship Status Partnered in a serious relationship	5 Participants n=5 Participants
Relationship Status Divorced or separated	1 Participants n=5 Participants
Number of times pregnant 1	13 Participants n=5 Participants
Number of times pregnant 2	18 Participants n=5 Participants
Number of times pregnant 3	12 Participants n=5 Participants
Number of times pregnant 4	4 Participants n=5 Participants
Number of times pregnant 5 or more	5 Participants n=5 Participants
Type of loss experienced - Chemical Pregnancy (i.e., loss before the 5th week)	4 Participants n=5 Participants
Type of loss experienced - Miscarriage in the first trimester	21 Participants n=5 Participants
Type of loss experienced - Neonatal loss	7 Participants n=5 Participants
Type of loss experienced - Stillbirth	11 Participants n=5 Participants
Type of loss experienced - Termination due to fetal abnormality/viability	4 Participants n=5 Participants
Type of loss experienced - Tubal or ectopic pregnancy	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Traumatic Stress - Intrusion Subscale Pretest	2.17 units on a scale Standard Deviation 0.92
Traumatic Stress - Intrusion Subscale 4-weeks	1.93 units on a scale Standard Deviation 0.90
Traumatic Stress - Intrusion Subscale 8-weeks	1.32 units on a scale Standard Deviation 1.01

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Traumatic Stress - Avoidance Subscale 4-weeks	1.44 units on a scale Standard Deviation 0.94
Traumatic Stress - Avoidance Subscale 8-weeks	1.23 units on a scale Standard Deviation 0.90
Traumatic Stress - Avoidance Subscale Pretest	1.61 units on a scale Standard Deviation 0.93

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Traumatic Stress - Hyperarousal Subscale Pretest	1.61 units on a scale Standard Deviation 1.03
Traumatic Stress - Hyperarousal Subscale 4-weeks	1.53 units on a scale Standard Deviation 1.04
Traumatic Stress - Hyperarousal Subscale 8-weeks	1.31 units on a scale Standard Deviation 1.01

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Grief Intensity - Reality Subscale Pretest	3.39 units on a scale Standard Deviation 0.57
Grief Intensity - Reality Subscale 4-weeks	3.41 units on a scale Standard Deviation 0.59
Grief Intensity - Reality Subscale 8-weeks	3.51 units on a scale Standard Deviation 0.60

PRIMARY outcome

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

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Grief Intensity - Congruence Subscale Pretest	2.48 units on a scale Standard Deviation 0.60
Grief Intensity - Congruence Subscale 4-weeks	2.59 units on a scale Standard Deviation 0.59
Grief Intensity - Congruence Subscale 8-weeks	2.66 units on a scale Standard Deviation 0.58

PRIMARY outcome

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

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Grief Intensity - Ability to Confront Others Subscale 8-weeks	2.55 units on a scale Standard Deviation 0.80
Grief Intensity - Ability to Confront Others Subscale Pretest	2.61 units on a scale Standard Deviation 0.89
Grief Intensity - Ability to Confront Others Subscale 4-weeks	2.71 units on a scale Standard Deviation 0.73

PRIMARY outcome

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

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Grief Management Self-efficacy Pretest	4.26 units on a scale Standard Deviation 0.94
Grief Management Self-efficacy 4-weeks	4.63 units on a scale Standard Deviation 0.91
Grief Management Self-efficacy 8-weeks	4.66 units on a scale Standard Deviation 1.00

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Negative Attitudes on Personal Grief Pretest	3.88 units on a scale Standard Deviation 1.33
Negative Attitudes on Personal Grief 4-weeks	3.59 units on a scale Standard Deviation 1.22
Negative Attitudes on Personal Grief 8-weeks	3.21 units on a scale Standard Deviation 1.19

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale Pretest	2.25 units on a scale Standard Deviation 1.19
Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale 4 weeks	2.35 units on a scale Standard Deviation 0.93
Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale 8 weeks	2.08 units on a scale Standard Deviation 0.95

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	PeriGrief n=52 Participants 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.
Difficulties in Emotional Regulation - Lack of Emotional Response Subscale Pretest	2.32 units on a scale Standard Deviation 0.77
Difficulties in Emotional Regulation - Lack of Emotional Response Subscale 4-weeks	2.38 units on a scale Standard Deviation 0.85
Difficulties in Emotional Regulation - Lack of Emotional Response Subscale 8-weeks	2.20 units on a scale Standard Deviation 0.79

PRIMARY outcome

Timeframe: Post-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.

Outcome measures

Measure

PeriGrief n=44 Participants 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.

Usability

74.4 units on a scale Standard Deviation 13.5

PRIMARY outcome

Timeframe: Post-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.

Outcome measures

Measure

PeriGrief n=45 Participants 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.

Acceptability

2.88 units on a scale Standard Deviation 0.29

PRIMARY outcome

Timeframe: Access 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.

Outcome measures

Measure

PeriGrief n=41 Participants 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.

Program Use - Days Using the Program

21.40 days Standard Deviation 23.39

PRIMARY outcome

Timeframe: Access 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.

Outcome measures

Measure	PeriGrief n=41 Participants 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.
Program Use - Modules Completed Did not complete any modules	4 Participants
Program Use - Modules Completed Completed one module	10 Participants
Program Use - Modules Completed Completed two modules	9 Participants
Program Use - Modules Completed Completed three modules	6 Participants
Program Use - Modules Completed Completed four modules	1 Participants
Program Use - Modules Completed Completed five modules	3 Participants
Program Use - Modules Completed Completed all six modules	8 Participants

Adverse Events

PeriGrief

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Smith

Oregon Research Behavior Intervention Strategies, Inc. dba Influents Innovations

Phone: 541-484-2123

Email: david.smith@influetnsin.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place