Mobile App-Based Mindfulness Intervention for Addressing Psychological Distress Among Survivors of Hospitalization for COVID-19 Infection.

BACKGROUND: Psychological distress symptoms are present and persistent among many patients who survive a critical illness like COVID-19. RESEARCH QUESTION: Could a self-directed mobile app-delivered mindfulness intervention be feasibly and rapidly implemented within a clinical trials network to reduce distress symptoms? STUDY DESIGN AND METHODS: A randomized clinical trial was conducted between January 2021 and May 2022 at 29 US sites and included survivors of hospitalization due to COVID-19-related illness with elevated symptoms of depression at discharge. Participants were randomized to intervention or usual care control. The intervention consisted of four themed weeks of daily audio, video, and text content. All study procedures were virtual. The primary outcome was depression symptoms assessed with the Patient Health Questionnaire 9 at 3 months. Secondary outcomes included anxiety (Generalized Anxiety Disorder 7-item scale), quality of life (EQ-5D), and adherence. We used general linear models to estimate treatment arm differences in outcomes over time. RESULTS: Among 56 randomized participants (mean age ± SD, 51.0 ± 13.2 years; 38 female [67.9%]; 14 Black participants [25%]), 45 (intervention: n = 23 [79%]; control: n = 22 [81%]) were retained at 6 months. There was no difference in mean improvement between intervention and control participants at 3 months in Patient Health Questionnaire 9 (-0.5 vs 0.1), Generalized Anxiety Disorder 7-item scale (-0.3 vs 0.1), or EQ-5D (-0.03 vs 0.02) scores, respectively; 6-month results were similar. Only 15 participants (51.7%) initiated the intervention, whereas the mean number ± SD of the 56 prescribed intervention activities completed was 12.0 ± 15.2. Regulatory approvals delayed trial initiation by nearly a year. INTERPRETATION: Among survivors of COVID-19 hospitalization with elevated psychological distress symptoms, a self-directed mobile app-based mindfulness intervention had poor adherence. Future psychological distress interventions mobilized at broad scale should focus efforts on patient engagement and regulatory simplification to enhance success. TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT04581200; URL: www.clinicaltrials.gov.

Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial.

Importance: Although psychological distress is common among survivors of critical illness, there are few tailored therapies. Objective: To determine the optimal method for delivering a mindfulness intervention via a mobile app for critical illness survivors. Design, Setting, and Participants: This randomized clinical trial used a 2 × 2 × 2 factorial design and was conducted at 3 sites among survivors of critical illness with elevated postdischarge symptoms of depression. The study was conducted between August 2019 and July 2023. Interventions: Participants were randomized to 1 of 8 different groups as determined by 3 two-level intervention component combinations: intervention introduction method (mobile app vs therapist call), mindfulness meditation dose (once daily vs twice daily), and management of increasing symptoms (mobile app vs therapist call). Main Outcomes and Measures: The primary outcome was the 9-item Patient Health Questionnaire (PHQ-9) depression scale score (range, 0-27) at 1 month. Secondary outcomes included anxiety (7-item Generalized Anxiety Disorder) and posttraumatic stress disorder (Posttraumatic Stress Scale) symptoms at 1 and 3 months, adherence, and feasibility. General linear models were used to compare main effects and interactions of the components among intervention groups. A formal decisional framework was used to determine an optimized intervention version. Results: A total of 247 participants (mean [SD] age, 50.2 [15.4] years; 104 [42.1%] women) were randomized. Twice-daily meditation compared with once-daily meditation was associated with a 1.2 (95% CI, 0.04-2.4)-unit lower mean estimated PHQ-9 score at 1 month and a 1.5 (95% CI, 0.1-2.8)-unit lower estimated mean score at 3 months. The other 2 intervention components had no main effects on the PHQ-9. Across-group adherence was high (217 participants [87.9%] using the intervention at trial conclusion) and retention was strong (191 [77.3%] and 182 [73.7%] at 1 and 3 months, respectively). Conclusions and Relevance: A mindfulness intervention for survivors of critical illness that included an app-based introduction, twice-daily guided meditation, and app-based management of increasing depression symptoms was optimal considering effects on psychological distress symptoms, adherence, and feasibility. Trial Registration: ClinicalTrials.gov Identifier: NCT04038567.

Couple-based communication intervention for head and neck cancer: a randomized pilot trial.

OBJECTIVE: To test feasibility and preliminary efficacy of a couple-based supportive communication (CSC) intervention for head and neck cancer (HNC) delivered during patients' oncology treatment. METHODS: Twenty couples were randomly assigned to either a four-session CSC or a treatment-as-usual (TAU) condition. The CSC intervention primarily focused on increasing couple emotional disclosure, supportive listening, and social support. Patients and partners completed measures of individual and relationship functioning at baseline, post-intervention, and 6-month follow-up. RESULTS: Ninety-eight percent of CSC sessions were completed and couples reported high levels of satisfaction with the intervention. Between-group effect sizes indicated that patients and partners in CSC reported improvements in individual and relationship functioning, relative to those in the TAU condition. CONCLUSIONS: A couple-based communication intervention delivered during oncology treatment is feasible and acceptable in the context of HNC and may lead to improvements in individual and relationship functioning. Preliminary efficacy results are interpreted in the context of social-cognitive processing and intimacy theories. TRIAL REGISTRATION: The trial was registered on www.clinicaltrials.gov (NCT01785576) first posted on February 7, 2013.

Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.

INTRODUCTION: Although as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1). OBJECTIVE: To describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs. METHODS AND ANALYSIS: The LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.

Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial.

BACKGROUND: Patients who are sick enough to be admitted to an intensive care unit (ICU) commonly experience symptoms of psychological distress after discharge, yet few effective therapies have been applied to meet their needs. METHODS: Pilot randomised clinical trial with 3-month follow-up conducted at two academic medical centres. Adult (≥18 years) ICU patients treated for cardiorespiratory failure were randomised after discharge home to 1 of 3 month-long interventions: a self-directed mobile app-based mindfulness programme; a therapist-led telephone-based mindfulness programme; or a web-based critical illness education programme. RESULTS: Among 80 patients allocated to mobile mindfulness (n=31), telephone mindfulness (n=31) or education (n=18), 66 (83%) completed the study. For the primary outcomes, target benchmarks were exceeded by observed rates for all participants for feasibility (consent 74%, randomisation 91%, retention 83%), acceptability (mean Client Satisfaction Questionnaire 27.6 (SD 3.8)) and usability (mean Systems Usability Score 89.1 (SD 11.5)). For secondary outcomes, mean values (and 95% CIs) reflected clinically significant group-based changes on the Patient Health Questionnaire depression scale (mobile (-4.8 (-6.6, -2.9)), telephone (-3.9 (-5.6, -2.2)), education (-3.0 (-5.3, 0.8)); the Generalized Anxiety Disorder scale (mobile -2.1 (-3.7, -0.5), telephone -1.6 (-3.0, -0.1), education -0.6 (-2.5, 1.3)); the Post-Traumatic Stress Scale (mobile -2.6 (-6.3, 1.2), telephone -2.2 (-5.6, 1.2), education -3.5 (-8.0, 1.0)); and the Patient Health Questionnaire physical symptom scale (mobile -5.3 (-7.0, -3.7), telephone -3.7 (-5.2, 2.2), education -4.8 (-6.8, 2.7)). CONCLUSIONS: Among ICU patients, a mobile mindfulness app initiated after hospital discharge demonstrated evidence of feasibility, acceptability and usability and had a similar impact on psychological distress and physical symptoms as a therapist-led programme. A larger trial is warranted to formally test the efficacy of this approach. TRIAL REGISTRATION NUMBER: Results, NCT02701361.

Couples and breast cancer: women's mood and partners' marital satisfaction predicting support perception.

Women who are diagnosed with breast cancer can experience an array of psychosocial difficulties; however, social support, particularly from a spouse, has been shown to have a protective function during this time. This study examined the ways in which a woman's daily mood, pain, and fatigue, and her spouse's marital satisfaction predict the woman's report of partner support in the context of breast cancer. Pretest data from a larger intervention study and multilevel modeling were used to examine the effects of women's daily mood, pain, and fatigue and average levels of mood, pain, and fatigue on women's report of social support received from her partner, as well as how the effects of mood interacted with partners' marital satisfaction. Results show that on days in which women reported higher levels of negative or positive mood, as well as on days they reported more pain and fatigue, they reported receiving more support. Women who, on average, reported higher levels of positive mood tended to report receiving more support than those who, on average, reported lower positive mood. However, average levels of negative mood were not associated with support. Higher average levels of fatigue but not pain were associated with higher support. Finally, women whose husbands reported higher levels of marital satisfaction reported receiving more partner support, but husbands' marital satisfaction did not moderate the effect of women's mood on support. Implications of these findings are discussed relative to assisting couples during this difficult time in their lives.

Men's psychological functioning in the context of women's breast cancer.

Previous research indicates that men are affected when their female partners have breast cancer. However, little is known about what predicts men's psychological well-being in this context. The current investigation involved couples in which the woman had early stage breast cancer and explored the degree to which men's positive and negative well-being was related to women's well-being, women's physical symptoms, relationship functioning, and relationship duration. The findings indicate that all of these factors play a role and interact in predicting men's well-being. In particular, when women have a high level of physical symptoms, the typical associations between men's well-being with women's well-being and relationship adjustment no longer persist. Implications for working with couples addressing health problems are provided.

Stress buffering effects of daily spousal support on women's daily emotional and physical experiences in the context of breast cancer concerns.

OBJECTIVE: This study examined whether the relationship between daily spousal support and daily psychological and physical outcomes varied as a function of level of breast cancer related concern (stress buffering model). DESIGN: Ninety-five women with early stage breast cancer completed daily reports of emotional and physical experiences and satisfaction with spousal support for 30 days. Women also rated problems dealing with three types of cancer specific concerns: emotional, physical, and social. MAIN OUTCOME MEASURES: Women's positive and negative affect and cancer related pain and fatigue. RESULTS: Multilevel analyses supported a stress buffering effect for social concerns and a reverse stress buffering effect for emotional and physical concerns. CONCLUSION: Daily spousal support appears to be an important contributor to the daily emotional and physical wellbeing of women with breast cancer. Contrary to the tenets of the stress buffering model, these data suggest that the buffering effect of spousal support is attenuated when breast cancer related emotional and physical concerns reach high levels.

A couple-based intervention for female breast cancer.

OBJECTIVE: Although women's breast cancer affects both women and their male partners, as well as their relationships, few interventions have been developed to work with couples confronting breast cancer. The current investigation presents the pilot results from a new couple-based intervention program for breast cancer that teaches couples how to minimize negative effects and maximize positive functioning during this difficult time. METHOD: In this pilot study, 14 couples in which the wife had early stage breast cancer were randomly assigned to one of the two treatment conditions: Couple-based relationship enhancement (RE) or treatment-as-usual (TAU). RESULTS: The results from this study suggest that compared with couples receiving treatment-as-usual, both women and men in the RE condition experienced improved functioning on individual psychological variables as well as relationship functioning at posttest and 1-year follow-up. In addition, women in RE show fewer medical symptoms at both time periods. CONCLUSIONS: In this pilot study, the couple-based intervention, RE, has shown promise in improving individual, medical, and relationship functioning for couples in which the woman is facing breast cancer, and therefore merits further investigation on a larger scale.

Quantifying the recruitment challenges with couple-based interventions for cancer: applications to early-stage breast cancer.

OBJECTIVE: Despite mounting evidence supporting the use of psychosocial interventions to promote adaptation to cancer, enrolling participants into these interventions is challenging. This is particularly salient for couple-based interventions, and newer, more targeted recruitment strategies to increase enrollment are needed. However, there have been few published empirical studies focused specifically on recruitment-related variables associated with enrollment into these types of interventions. To better understand how to encourage participation in couple-based psychosocial interventions for cancer, we examined facilitating and impeding factors to enrollment into a couple-based intervention for women with early-stage breast cancer. METHOD: In this sample of 99 women diagnosed with early-stage breast cancer, patient demographic variables and method of approaching eligible patients were examined as predictors of enrollment into a randomized controlled trial comparing couple-based relationship enhancement with treatment as usual. RESULTS: Results indicated that women were more likely to enroll if they were contacted at home or at a follow-up medical appointment rather than when first diagnosed at a busy multidisciplinary clinic; they were also more likely to enroll the closer they lived to the research facility. CONCLUSIONS: In addition to decreasing participant burden, timing and setting of recruitment efforts may have important implications for enhancing participation rates in couple-based intervention studies for cancer.

Psychosocial issues confronting young women with breast cancer.

The current paper reviews the literature regarding psychosocial issues confronting young women with breast cancer. The findings indicate that younger women with breast cancer experience a lower quality of life after cancer compared to older women. In part, this lower quality of life results from the effects of medical treatment. The effects of surgery and removal of the breast result in more negative feelings regarding body image, particularly for young women. With systemic treatment, many younger women experience the sudden onset of menopause, with the attendant symptoms of hot flashes, decreased sexual desire, and vaginal dryness. These physical effects along with a variety of relationship issues contribute to a high level of sexual concerns for young women. From a psychosocial perspective, breast cancer affects both females and their male partners. Both partners experience psychological distress including depression and anxiety. Within the relationship, emotional support from the partner is important in women's adjustment. In terms of psychosocial interventions for breast cancer, findings suggest that the most frequently employed interventions, which treat the woman without her partner, are not optimal. Initial findings provide encouraging evidence that couple-based psychosocial interventions for women and their partners might be of particular assistance to both partners.

Psychometric analysis of the Psychopathic Personality Inventory (PPI) with female inmates.

This study evaluated the reliability, internal structure, and validity of the Psychopathic Personality Inventory (PPI; Lilienfeld & Andrews, 1996) among female inmates (n = 153) housed at a multilevel prison facility. Findings from this research suggested both strengths and weaknesses associated with PPI psychopathy assessment. Reliability of the PPI was supported by internal consistency analyses of scale and subscale item sets, and test-retest reliability was supported by findings obtained with a subsample (n = 36) retested an average of 49 days after initial test administration. Validity of the PPI total score was also supported by moderate to very high correlations with other self-report measures of psychopathy. Relative weaknesses of the PPI were evident by the low or negative associations among many of the PPI subscales, moderate associations that PPI total scores demonstrated with response set indexes, and the similarity of PPI total scores among female inmates and undergraduates. Findings from this research are considered in relation to possible sex differences in the expression of psychopathy and challenges associated with the assessment of the psychopathy construct with self-report methods.