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Guided Self-Help Works: Randomized Waitlist Controlled Trial of Pacifica, a Mobile App Integrating Cognitive Behavioral Therapy and Mindfulness for Stress, Anxiety, and Depression.

ABSTRACT: BACKGROUND:Despite substantial improvements in technology and the increased demand for technology-enabled behavioral health tools among consumers, little progress has been made in easing the burden of mental illness. This may be because of the inherent challenges of conducting traditional clinical trials in a rapidly evolving technology landscape. OBJECTIVE:This study sought to validate the effectiveness of Pacifica, a popular commercially available app for the self-management of mild-to-moderate stress, anxiety, and depression. METHODS:A total of 500 adults with mild-to-moderate anxiety or depression were recruited from in-app onboarding to participate in a randomized waitlist controlled trial of Pacifica. We conducted an all-virtual study, recruiting, screening, and randomizing participants through a Web-based participant portal. Study participants used the app for 1 month, with no level of use required, closely mimicking real-world app usage. Participants in the waitlist group were given access to the app after 1 month. Measurements included self-reported symptoms of stress, anxiety, depression, and self-efficacy. We performed an intent-to-treat analysis to examine the interactive effects of time and condition. RESULTS:We found significant interactions between time and group. Participants in the active condition demonstrated significantly greater decreases in depression, anxiety, and stress and increases in self-efficacy. Although we did not find a relationship between overall engagement with the app and symptom improvement, participants who completed relatively more thought record exercises sustained improvements in their symptoms through the 2-month follow-up to a greater degree than those who completed fewer. In addition, we found that participants who reported concomitantly taking psychiatric medications during the trial benefitted less from the app, as measured by the symptoms of anxiety and stress. CONCLUSIONS:This study provides evidence that Pacifica, a popular commercially available self-help app, is effective in reducing self-reported symptoms of depression, anxiety, and stress, particularly among individuals who utilize thought records and are not taking psychiatric medication. TRIAL REGISTRATION:ClinicalTrials.gov NCT03333707; https://clinicaltrials.gov/ct2/show/NCT03333707 (Archived by WebCite at http://www.webcitation.org/78YE07ADB).

SUBMITTER: Moberg C

PROVIDER: S-EPMC6592477 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Guided Self-Help Works: Randomized Waitlist Controlled Trial of Pacifica, a Mobile App Integrating Cognitive Behavioral Therapy and Mindfulness for Stress, Anxiety, and Depression.

Moberg Christine C Niles Andrea A Beermann Dale D

Journal of medical Internet research 20190608 6

<h4>Background</h4>Despite substantial improvements in technology and the increased demand for technology-enabled behavioral health tools among consumers, little progress has been made in easing the burden of mental illness. This may be because of the inherent challenges of conducting traditional clinical trials in a rapidly evolving technology landscape.<h4>Objective</h4>This study sought to validate the effectiveness of Pacifica, a popular commercially available app for the self-management of ...[more]

PMID: 31199319

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Project description:BackgroundCollege athletes are a group often affected by anxiety. Few interventional studies have been conducted to address the anxiety issues in this population.ObjectiveWe conducted a mobile-delivered mindfulness intervention among college athletes to study its feasibility and efficacy in lowering their anxiety level and improving their mindfulness (measured by the Five Facet Mindfulness Questionnaire [FFMQ]).MethodsIn April 2019, we recruited 290 college athletes from a public university in Shanghai, China, and 288 of them were randomized into an intervention group and a control group (closed trial), with the former (n=150) receiving a therapist-guided, smartphone-delivered mindfulness-based intervention and the latter receiving mental health promotion messages (n=138). We offered in-person instructions during the orientation session for the intervention group in a classroom, with the therapist interacting with the participants on the smartphone platform later during the intervention. We used generalized linear modeling and the intent-to-treat approach to compare the 2 groups' outcomes in dispositional anxiety, precompetition anxiety, and anxiety during competition, plus the 5 dimensions of mindfulness (measured by the FFMQ).ResultsOur intent-to-treat analysis and generalized linear modeling found no significant difference in dispositional anxiety, precompetition anxiety, or anxiety during competition. Only the "observation" facet of mindfulness measures had a notable difference between the changes experienced by the 2 groups, whereby the intervention group had a net gain of .214 yet fell short of reaching statistical significance (P=.09). Participants who specialized in group sports had a higher level of anxiety (β=.19; SE=.08), a lower level of "nonjudgemental inner experience" in FFMQ (β=-.07; SE=.03), and a lower level of "nonreactivity" (β=-.138; SE=.052) than those specializing in individual sports.ConclusionsNo significant reduction in anxiety was detected in this study. Based on the participant feedback, the time availability for mindfulness practice and session attendance for these student athletes in an elite college could have compromised the intervention's effectiveness. Future interventions among this population could explore a more student-friendly time schedule (eg, avoid final exam time) or attempt to improve cognitive and scholastic outcomes.Trial registrationChinese Clinical Trial Registry ChiCTR1900024449; https://www.chictr.org.cn/showproj.html?proj=40865.

Project description:BACKGROUND:Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving access to psychological therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild to moderate, people are typically offered cognitive behavioural therapy (CBT) self-help (CBT-SH) supported by a psychological well-being practitioner. The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs from CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions. METHODS/DESIGN:This is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16?weeks, with six support sessions with a psychological well-being practitioner. The primary outcome is depression symptom severity on treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, well-being, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. DISCUSSION:If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. TRIAL REGISTRATION:Current Controlled Trial registration number: ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752).

Project description:BackgroundPsychological distress is a common occurrence among women during the perinatal period. Maternal psychological distress (MPS) can also have a negative influence on neonatal outcomes such as infant health, child development or mother-child interaction. Hence, interventions to improve mental wellbeing during this period are vital. Mindfulness based intervention (MBI) has been found to be effective in reducing psychological distress. Delivery of MBI via the internet, making it accessible and inexpensive, is showing a promising positive effect in reducing psychological distress. A randomized control trial with sufficient power is required to confirm its positive effect among pregnant women. The positive effects of MBI have been found to be associated with heart rate variability (HRV) biofeedback; however, the efficacy of MBI on HRV has been rarely studied among pregnant women. Also, the potential association of HRV with MBI and psychological wellbeing needs further examination. This research aims to test the effectiveness of guided mobile-based perinatal mindfulness intervention (GMBPMI) among pregnant women experiencing psychological distress during the pre- and post-natal period, as well as examining the efficacy of GMBPMI on HRV.MethodThis study is a randomized controlled trial that follows a parallel design. Consenting pregnant women in their second trimester (between 12th and 20th week gestation) will be randomly assigned to an intervention group (GMBPMI) or a control group (psychoeducation). The intended sample size is 198, with 99 participants in each group. Three levels of outcomes will be measured at baseline, post intervention in both the intervention and control groups, and at 36-week gestation and five-week postpartum. The primary outcomes include maternal psychological stress, mindfulness and positive appraisal HRV. Secondary outcomes are psychological and physical wellbeing. Tertiary outcomes include obstetric and neonatal outcomes, and social support. Analyses will follow an intention-to-treat method and repeated measures MANOVA will be conducted to compare changes in primary and secondary outcomes. A series of mixed-effects models will be fitted to assess the mediation effects.DiscussionThis trial expects to increase understanding of GMBPMI on HRV and psychological wellbeing for pregnant women, with extended support in both pre-and post-natal periods. The study could also potentially provide evidence for delivery of cost-effective and accessible services to pregnant women.Trial registrationClinicalTrials.gov: NCT04876014, registered on 30 March 2021. Protocol Version 1.0., 10 May 2021.

Project description:IntroductionRelapse following acute treatment for anorexia nervosa (AN) is common. Evidence suggests cognitive-behavioral therapy (CBT) may be useful in the post-acute period, but few patients have access to trained providers. mHealth technologies have potential to increase access to high-quality care for AN, including in the post-acute period. The aim of this study is to estimate the preliminary feasibility and effectiveness of a CBT-based mobile intervention plus treatment as usual (TAU), offered with and without an accompanying social networking feature.MethodIn the current pilot randomized controlled trial, women with AN who have been discharged from acute treatment in the past 2 months (N = 90) will be randomly assigned to a CBT-based mobile intervention plus treatment as usual (TAU), a CBT-based mobile intervention including social networking plus TAU, or TAU alone. We will examine feasibility, acceptability, and preliminary effectiveness of the three conditions in terms of reducing eating disorder psychopathology, reducing frequency of eating disorder behaviors, achieving weight maintenance, reducing depression and suicidal ideation, and reducing clinical impairment. We will examine rehospitalization and full recovery rates in an exploratory fashion. We will also examine whether the mobile intervention and social networking feature change the proposed targets and whether changes in targets are associated with benefit, as well as conduct exploratory analyses to identify within-mobile intervention predictors and moderators of outcome.DiscussionUltimately, this research may lead to increased access to evidence-based treatment for individuals with AN and prevention of the extreme negative consequences that can result from this serious disorder.Public significanceRelapse after acute treatment for anorexia nervosa is common, and few patients have access to trained providers to support them following acute care. This study will pilot a coached mobile app, including a social networking component, for this population. If ultimately successful, our approach could greatly increase access to evidence-based treatment for individuals with anorexia nervosa and ultimately prevent the extreme negative consequences that can result from this serious disorder.

Project description:ImportanceDepression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required.ObjectiveTo determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH is cost-effective compared with practitioner-supported CBT-SH.Design, setting, and participantsThis was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021.InterventionsParticipants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner.Main outcomes and measuresThe preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked.ResultsOf 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of -1.5 PHQ-9 points (95% CI, -2.6 to -0.4; P = .009; d = -0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related.Conclusions and relevanceIn this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be routinely offered to adults in primary care services.Trial registrationisrctn.org Identifier: ISRCTN13495752.

Project description:BackgroundObsessive-compulsive disorder (OCD) is a disabling condition with a wide variety of clinical presentations including contamination fears, fear of harm, and relationship-related obsessions. Cognitive behavioral models of OCD suggest that OC symptoms result from catastrophic misinterpretations of commonly occurring intrusive experiences and associated dysfunctional strategies used to manage them. OCD-related maladaptive beliefs including inflated responsibility, importance and control of thoughts, perfectionism, and intolerance for uncertainty increase the likelihood of such misinterpretations.ObjectiveConsidering accumulating evidence suggesting that mobile health (mHealth) apps based on cognitive-behavioral principles may lead to significant reductions in psychopathological symptoms, we assessed the effectiveness of a novel cognitive training app (GGRO) designed to challenge OCD-related beliefs.MethodsA total of 97 students were randomized to groups undertaking immediate-use (iApp) or delayed use (dApp) of GGRO. All participants were requested to complete Web-based assessments, with questionnaires relating to maladaptive beliefs, mood, and OC symptoms at baseline (T1), 15 days from baseline (T2), and 30 days from baseline (T3). Participants in iApp group started using the app at baseline and continued using the app for 15 consecutive days. They were then requested to stop using the app until T3. Participants in the dApp group were requested to wait for 15 days and only then start using the app (crossover) for 15 consecutive days.ResultsAll participants used the app for a mean of 14.07 (SD 1.41) days with 2.94 levels per day. Consistent with previous findings, app use was associated with medium-large effect size reductions in both iApp (n=51) and dApp (n=46) groups. In the iApp group, all effects remained significant during the 15 days of follow-up. Analyses focusing on the first two assessment occasions revealed significant treatment × repeated measures interactions on maladaptive beliefs, several OC symptom measures, and self-esteem.ConclusionsThis study provides further evidence for the efficacy of GGRO as a mobile-delivered training exercise that is useful for reducing OCD-related beliefs and symptoms.Trial registrationClinicalTrials.gov NCT03571464; https://clinicaltrials.gov/ct2/show/NCT03571464 (Archived by WebCite at http://www.webcitation.org/7675sYPsH).

Dataset Information

Guided Self-Help Works: Randomized Waitlist Controlled Trial of Pacifica, a Mobile App Integrating Cognitive Behavioral Therapy and Mindfulness for Stress, Anxiety, and Depression.

Publications

Guided Self-Help Works: Randomized Waitlist Controlled Trial of Pacifica, a Mobile App Integrating Cognitive Behavioral Therapy and Mindfulness for Stress, Anxiety, and Depression.

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