To assess feasibility and preliminary efficacy of a mobile/online-based (mHealth) mindfulness intervention for cancer patients and their caregivers to reduce distress and improve quality of life (QoL). Material and Methods: Twoarm randomized controlled trial within Kaiser Permanente Northern California targeting cancer patients who received chemotherapy and their informal caregivers. The intervention group received a commercially available mindfulness program for 8 weeks. The wait-list control group received usual care. We assessed feasibility using retention and adherence rates and obtained participant-reported data on distress, QoL, sleep, mindfulness, and posttraumatic growth before and immediately after the intervention. Results: Ninety-seven patients (median age 59 years; female 69%; 65% whites) and 31 caregivers (median age 63 years; female 58%; 77% whites) were randomized. Among randomized participants, 74% of the patients and 84% of the caregivers completed the study. Among those in the intervention arm who initiated the mindfulness program, 65% practiced at least 50% of the days during the intervention period. We observed significantly greater improvement in QoL among patients in the intervention arm compared with controls. Caregivers in the intervention group experienced increased mindfulness compared with controls. Participants appreciated the convenience of the intervention and the mindfulness skills they obtained from the program. Conclusion: We demonstrated the feasibility of conducting a randomized trial of an mHealth mindfulness intervention for cancer patients and their informal caregivers. Results from fully powered efficacy trials would inform the potential for clinicians to use this scalable intervention to help improve QoL of those affected by cancer and their caregivers.

Background Approximately 20% of women suffer from postpartum depression (PPD). Due to barriers such as limited access to care, half of the women with PPD do not receive treatment. Therefore, it is critical to identify effective and scalable interventions. Traditional mindfulness programs have been effective in reducing depressive symptoms, however access remains a barrier. A self-paced mobile health (mHealth) mindfulness program may fit the lifestyle of busy mothers who are unable to attend in-person classes. However, little is known regarding the feasibility or efficacy of mHealth mindfulness interventions in postpartum women with depressive symptoms. Objective This study aims to assess the feasibility, acceptability, and preliminary efficacy of an mHealth mindfulness intervention for postpartum women with moderate to moderately severe depressive symptoms. Methods We conducted a single-arm feasibility trial of an mHealth mindfulness intervention within Kaiser Permanente Northern California (KPNC), a large integrated health care system. Participants were identified through clinician referral and electronic health records via KPNC's universal perinatal depression screening program and recruited by the study team. Inclusion criteria included the following: English-speaking, up to 6 months postpartum with a Patient Health Questionnaire (PHQ-8) score of 10 to 19, and no regular mindfulness/meditation practice. Participants were asked to use a mindfulness app, Headspace, 10 to 20 min/day for 6 weeks. Baseline and postintervention surveys captured data on patient-reported outcomes (depression and stress symptoms, sleep quality, and mindfulness). Semistructured interviews captured acceptability. Retention and adherence were used to assess feasibility. Results Of the 115 women who were contacted and met the eligibility criteria or declined participation before eligibility assessment, 27 (23%) were enrolled. In addition, 70% (19/27) completed the study. The mean age of participants was 31 years (SD 5.2), 30% (8/27) were non-Hispanic White, and, on average, participants were 12.3 weeks postpartum (SD 5.7). Of the women who completed the study, 100% (19/19) used the Headspace app at least once, and nearly half (9/19, 47%) used the app on ≥50% of the days during the 6-week intervention period. Of the 16 participants who completed the postintervention interview, 69% (11/16) reported that they were very or extremely satisfied with the app. Interviews indicated that women appreciated the variety of meditations and felt that the program led to reduced anxiety and improved sleep. Significant improvements in pre- and postintervention scores were observed for depressive symptoms (PHQ-8: −3.8, P=.004), perceived stress (10-item Perceived Stress Scale: −6.0, P=.005), and sleep quality (Pittsburgh Sleep Quality Index: −2.1, P=.02, indicating less sleep disturbance). Improvements in mindfulness were also significant (Five Facet Mindfulness Questionnaire-Short Form: 10.9, P=.01). Conclusions An mHealth mindfulness intervention for postpartum women with moderate to moderately severe depressive symptoms is feasible and acceptable. An efficacy trial is warranted.

Objectives Traditional mindfulness-based interventions have been shown to reduce depression symptoms in pregnant women, although in-person classes may pose significant accessibility barriers, particularly during the COVID-19 pandemic. Mobile technology offers greater convenience, but little is known regarding the efficacy of self-paced, mobile-delivered (mHealth) mindfulness interventions in this population. This study tested the feasibility and acceptability of offering such an intervention for pregnant women with moderate-to-moderately-severe depression symptoms. Methods We conducted a single-arm trial within Kaiser Permanente Northern California (KPNC). Participants were identified through KPNC’s universal perinatal depression screening program. Eligible participants included English-speaking pregnant women (<28 weeks of gestation) with moderate-to-moderately-severe depressive symptoms without a regular (<3 times/week) mindfulness/meditation practice. Participants were asked to follow a self-paced, 6-week mindfulness meditation program using a mobile app, Headspace™, 10–20 min/day. Outcome measures included feasibility, acceptability, and patient-reported outcomes (e.g., depression symptoms). Results Of the 27 women enrolled, 20 (74%) completed the study. Over half (55%) of participants used the app ≥50% of the days during the 6-week intervention. Responses to the semi-structured interviews indicated that women appreciated the convenience of the intervention and the ability to engage without having to attend classes or arrange childcare. We observed significant improvements in pre-postintervention scores for depression symptoms, perceived stress, sleep disturbance, and mindfulness. Conclusions Our study demonstrates the feasibility and acceptability of an mHealth mindfulness intervention for women with moderate-to-moderately-severe antenatal depression symptoms. The preliminary data further suggest that an efficacy trial is warranted.

BACKGROUND Postpartum depression (PPD) is the leading complication of childbirth impacting up to 20% of postpartum women. Half of the women with PPD do not receive treatment due to barriers to current treatment options such as a shortage of mental health care providers and limited access to care. Therefore, it is critical to identify safe, effective, and scalable intervention options for PPD. While traditional mindfulness programs have been effective in reducing depressive symptoms in many populations, access remains a barrier. A self-paced mindfulness-based mobile health application (mHealth) may fit the lifestyle of busy moms who are unable to attend in-person classes. Thus, they have the potential to improve adherence and efficacy. Research is needed to assess the effectiveness of mHealth mindfulness interventions in postpartum women with depression symptoms. OBJECTIVE To assess the feasibility and acceptability of an mHealth mindfulness-based intervention for postpartum women with moderate-to-moderately severe depression symptoms. METHODS We conducted a mixed-methods single-arm trial of an mHealth mindfulness intervention within Kaiser Permanente Northern California (KPNC), a large integrated healthcare system. Participants were identified through KPNC’s universal perinatal depression screening program and recruited via clinician referral or contact from the study team. English-speaking women, up to 6 months postpartum with an 8-item Patient Health Questionnaire (PHQ-8) score 10-19, and no regular mindfulness, meditation, or yoga practice were eligible. Participants were asked to use a commercially-available mindfulness mobile app, HeadspaceTM, 10-20 minutes/day for 6 weeks. Baseline and post-intervention surveys captured data on patient-reported outcomes (depression and stress symptoms, sleep, and mindfulness). Qualitative interviews were conducted post-intervention to assess acceptability. Retention and adherence to the intervention were used to assess feasibility. RESULTS Of the 27 women enrolled, 19 (70%) completed the study. The median age of participants was 31 years (range: 22-40), 30% were non-Hispanic White, and, on average, participants were 12.3 weeks postpartum (range 5-24). Of the women who completed the study, 100% used the Headspace app at least once and nearly half (47%) used the app ≥50% of the days during the 6-week intervention period. Of the 16 participants who completed the post-intervention interview, 69% reported that they were “very” or “extremely” satisfied with the app. Interviews indicate that women appreciated the variety of meditations available and felt the program led to reduced anxiety and improved sleep. Significant improvements in pre-post intervention scores were observed for depression symptoms (PHQ-8: -3.8, P=.004), perceived stress (10-item Perceived Stress Scale: -6.0, P=.005) and sleep quality (Pittsburgh Sleep Quality Index: -2.1, P=.02, indicating less sleep disturbance). Improvements in mindfulness were also significant (Five Facet Mindfulness Questionnaire short form: +10.9, P=.01). CONCLUSIONS Findings suggest an mHealth mindfulness intervention for postpartum women with moderate-to-moderately severe depression symptoms is feasible and acceptable. An efficacy trial is warranted. CLINICALTRIAL N/A