Dataset Information

Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.

ABSTRACT:

Importance

Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands.

Objective

To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.

Design, setting, and participants

Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018.

Interventions

The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform.

Main outcomes and measures

Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period.

Results

One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively.

Conclusions and relevance

In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs.

Trial registration

ClinicalTrials.gov Identifier: NCT03500536.

SUBMITTER: Graham AK

PROVIDER: S-EPMC7240649 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:Depression and anxiety symptoms are common among university students, but many do not receive treatment. This is often because of lack of availability, reluctance to seek help, and not meeting the diagnostic criteria required to access services. Internet-based interventions, including smartphone apps, can overcome these issues. However, a large number of apps are available, each with little evidence of their effectiveness. OBJECTIVE:This study aims to evaluate for the first time the effectiveness of a self-guided mobile app, Feel Stress Free, for the treatment of depression and anxiety symptoms in students. METHODS:A web-based randomized controlled trial compared a cognitive behavioral therapy (CBT)-based mobile app Feel Stress Free with a wait-list control. University students self-identified as experiencing symptoms of anxiety or depression and were randomized to 6 weeks of intervention (n=84) or control (n=84), unblinded. The app is self-guided and incorporates behavioral relaxation activities, mood tracking and thought challenging, and minigames. Participants completed the Hospital Anxiety and Depression Scale online at baseline and every fortnight. RESULTS:At week 6, the primary end point, there was evidence that the Feel Stress Free app reduced depression symptoms (mean difference -1.56; 95% CI -2.67 to -0.44; P=.006) but only very weak evidence that it reduced anxiety symptoms (mean difference -1.36; 95% CI -2.93 to 0.21; P=.09). At week 4, there was evidence to support the effectiveness of the intervention for anxiety symptoms (mean difference -1.94; 95% CI -3.11 to -0.77; P=.001) and, though weaker, depression symptoms (mean difference -1.08; 95% CI -2.12 to -0.04; P=.04). At week 6, 83% (34/41) of participants indicated that they were using the app weekly or more frequently. CONCLUSIONS:The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT. Further research is needed to establish its effectiveness at and beyond 6 weeks. TRIAL REGISTRATION:ClinicalTrials.gov NCT03032952; https://clinicaltrials.gov/ct2/show/NCT03032952.

Project description:ImportanceAnxiety and depression affect 30% of youth but are markedly undertreated compared with other mental disorders, especially in Hispanic populations.ObjectiveTo examine whether a pediatrics-based behavioral intervention targeting anxiety and depression improves clinical outcome compared with referral to outpatient community mental health care.Design, setting, and participantsThis 2-center randomized clinical trial with masked outcome assessment conducted between brief behavioral therapy (BBT) and assisted referral to care (ARC) studied 185 youths (aged 8.0-16.9 years) from 9 pediatric clinics in San Diego, California, and Pittsburgh, Pennsylvania, recruited from October 6, 2010, through December 5, 2014. Youths who met DSM-IV criteria for full or probable diagnoses of separation anxiety disorder, generalized anxiety disorder, social phobia, major depression, dysthymic disorder, and/or minor depression; lived with a consenting legal guardian for at least 6 months; and spoke English were included in the study. Exclusions included receipt of alternate treatment for anxiety or depression, presence of a suicidal plan, bipolar disorder, psychosis, posttraumatic stress disorder, substance dependence, current abuse, intellectual disability, or unstable serious physical illness.InterventionsThe BBT consisted of 8 to 12 weekly 45-minute sessions of behavioral therapy delivered in pediatric clinics by master's-level clinicians. The ARC families received personalized referrals to mental health care and check-in calls to support accessing care from master's-level coordinators.Main outcomes and measuresThe primary outcome was clinically significant improvement on the Clinical Global Impression-Improvement scale (score ≤2). Secondary outcomes included the Pediatric Anxiety Rating Scale, Children's Depression Rating Scale-Revised, and functioning.ResultsA total of 185 patients were enrolled in the study (mean [SD] age, 11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] white; and 38 [20.7%] Hispanic). Youths in the BBT group (n = 95), compared with those in the ARC group (n = 90), had significantly higher rates of clinical improvement (56.8% vs 28.2%; χ21 = 13.09, P < .001; number needed to treat, 4), greater reductions in symptoms (F2,146 = 5.72; P = .004; Cohen f = 0.28), and better functioning (mean [SD], 68.5 [10.7] vs 61.9 [11.9]; t156 = 3.64; P < .001; Cohen d = 0.58). Ethnicity moderated outcomes, with Hispanic youth having substantially stronger response to BBT (76.5%) than ARC (7.1%) (χ21 = 14.90; P < .001; number needed to treat, 2). Effects were robust across sites.Conclusions and relevanceA pediatric-based brief behavioral intervention for anxiety and depression is associated with benefits superior to those of assisted referral to outpatient mental health care. Effects were especially strong for Hispanic participants, suggesting that the protocol may be a useful tool in addressing ethnic disparities in care.Trial registrationclinicaltrials.gov Identifier: NCT01147614.

Project description:BackgroundDespite 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.ObjectiveThis 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.MethodsA 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.ResultsWe 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.ConclusionsThis 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 registrationClinicalTrials.gov NCT03333707; https://clinicaltrials.gov/ct2/show/NCT03333707 (Archived by WebCite at http://www.webcitation.org/78YE07ADB).

Project description:BACKGROUND:IntelliCare is a modular platform that includes 12 simple apps targeting specific psychological strategies for common mental health problems. OBJECTIVE:This study aimed to examine the effect of 2 methods of maintaining engagement with the IntelliCare platform, coaching, and receipt of weekly recommendations to try different apps on depression, anxiety, and app use. METHODS:A total of 301 participants with depression or anxiety were randomized to 1 of 4 treatments lasting 8 weeks and were followed for 6 months posttreatment. The trial used a 2X2 factorial design (coached vs self-guided treatment and weekly app recommendations vs no recommendations) to compare engagement metrics. RESULTS:The median time to last use of any app during treatment was 56 days (interquartile range 54-57), with 253 participants (84.0%, 253/301) continuing to use the apps over a median of 92 days posttreatment. Receipt of weekly recommendations resulted in a significantly higher number of app use sessions during treatment (overall median=216; P=.04) but only marginal effects for time to last use (P=.06) and number of app downloads (P=.08). Coaching resulted in significantly more app downloads (P<.001), but there were no significant effects for time to last download or number of app sessions (P=.36) or time to last download (P=.08). Participants showed significant reductions in the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) across all treatment arms (P s<.001). Coached treatment led to larger GAD-7 reductions than those observed for self-guided treatment (P=.03), but the effects for the PHQ-9 did not reach significance (P=.06). Significant interaction was observed between receiving recommendations and time for the PHQ-9 (P=.04), but there were no significant effects for GAD-7 (P=.58). CONCLUSIONS:IntelliCare produced strong engagement with apps across all treatment arms. Coaching was associated with stronger anxiety outcomes, and receipt of recommendations enhanced depression outcomes. TRIAL REGISTRATION:ClinicalTrials.gov NCT02801877; https://clinicaltrials.gov/ct2/show/NCT02801877.

Project description:BackgroundCollaborative care (CC) could improve outcomes in primary care patients with common mental conditions. We assessed the effectiveness of a transdiagnostic model of telephone-based CC (tCC) delivered by lay providers to primary care patients with depression, anxiety, or at-risk drinking.MethodsPARTNERS was a pragmatic trial in 502 primary care adults presenting with depressive symptoms, anxiety symptoms, or at-risk drinking randomized to (1) usual care by primary care providers (PCPs) enhanced with the results of computer-assisted telephone-based assessments (at baseline and 4, 8, and 12 months later) (enhanced usual care [eUC]) or (2) tCC consisting of eUC plus frequent telephone coaching and psychoeducation provided by mental health technicians who also communicated to the PCP recommendations from a psychiatrist for evidence-based pharmacotherapy, psychotherapy, or, when indicated, referrals to mental health services. The primary analysis compared the change on the 9-item Patient Health Questionnaire (PHQ-9) in participants presenting with depression (n = 366) randomized to tCC versus eUC. Secondary analyses compared changes on the Generalized Anxiety Disorder-7 scale (GAD-7) in those presenting with anxiety (n = 298); or change in the number of weekly drinks in those presenting with at-risk drinking (n = 176).ResultsThere were no treatment or time×treatment effects between tCC and eUC on PHQ-9 scores for patients with depression during the 12-month follow-up. However, there was a treatment effect (tCC > eUC) on GAD-7 scores in those with anxiety and a time×treatment interaction effect on the number of weekly drinks (tCC > eUC) in those with at-risk drinking.ConclusionImplementing transdiagnostic tCC for common mental disorders using lay providers appears feasible in Canadian primary care. While tCC was not better than eUC for depression, there were some benefits for those with anxiety or at-risk drinking. Future studies will need to confirm whether tCC differentially benefits patients with depression, anxiety, or at-risk drinking.

Project description:ImportanceAnxiety disorders are prevalent and undertreated among young adults. Digital mental health interventions for anxiety are promising but limited by a narrow range of therapeutic components and low user engagement.ObjectiveTo investigate the efficacy of and engagement with Maya, a scalable, self-guided, comprehensive mobile cognitive behavioral therapy (CBT) intervention with embedded engagement features, comparing the effects of 3 incentive conditions.Design, setting, and participantsThis randomized clinical trial recruited young adults aged 18 to 25 years with anxiety disorders through online advertisements and outpatient psychiatry clinics at Weill Cornell Medicine. Enrollment was between June 16, 2021, and November 11, 2022. Data analysis was performed from December 21, 2022, to June 14, 2024.InterventionParticipants received a 6-week program of the intervention and were randomized to 1 of 3 different text message-based incentive conditions (gain-framed, loss-framed, or gain-social support).Main outcomes and measuresThe primary outcome was change in anxious symptoms from baseline to end of treatment, as measured by the Hamilton Anxiety Rating Scale (HAM-A). The Anxiety Sensitivity Index and the Leibowitz Social Anxiety Scale scores were secondary measures.ResultsThe sample consisted of 59 participants (mean [SD] age, 23.1 [1.9] years; 46 [78%] female; 22 [37%] Asian, 3 [5%] Black, 5 [8%] Hispanic or Latino, 1 [2%] American Indian or Alaska Native, 25 [42%] White, and 6 [10%] >1 race; 32 [54%] college-educated and 12 [20%] graduate or professional school-educated; mean [SD] baseline HAM-A score, 15.0 [6.5]). Anxiety, measured by HAM-A, decreased across conditions from baseline to end of the intervention (mean difference, -5.64; 95% CI, -7.23 to -4.05), and symptomatic improvement was maintained at the week 12 follow-up (baseline to follow-up mean difference, -5.67; 95% CI, -7.29 to -4.04). However, there was no evidence that change in anxiety differed by incentive condition (loss-framed vs gain-social support mean difference, -1.40; 95% CI, -4.72 to 1.93; gain-framed vs gain-social support mean difference, 1.38; 95% CI, -1.19 to 3.96). Secondary anxiety measures (Anxiety Sensitivity Index and Liebowitz Social Anxiety Scale scores) showed a similar pattern of improvement, with no evidence of differences between incentive conditions. Participants completed most of the 12 sessions (mean [SD], 10.8 [2.1]; 95% CI, 10.3-11.4), and User Mobile Application Rating Scale app quality ratings exceeded the published threshold for acceptability at all study visits. There was no evidence that either session completion or app quality ratings differed by incentive condition.Conclusions and relevanceIn this randomized clinical trial of an app-based intervention for anxiety, the primary hypothesis that improvement in anxiety would be greatest in the condition using gain of points plus social incentives was not supported; however, the results suggest that a CBT application incorporating a full suite of CBT skills and embedded user engagement features was efficacious in improving symptoms in young adults with anxiety disorders. Given these findings, digital interventions represent a promising step toward wider dissemination of high-quality, evidence-based interventions.Trial registrationClinicalTrials.gov Identifier: NCT05130281.

Project description:ImportanceUp to 20% of adolescents experience an episode of major depression by age 18 years yet few receive evidence-based treatments for their depression.ObjectiveTo determine whether a collaborative care intervention for adolescents with depression improves depressive outcomes compared with usual care.DesignRandomized trial with blinded outcome assessment conducted between April 2010 and April 2013.SettingNine primary care clinics in the Group Health system in Washington State.ParticipantsAdolescents (aged 13-17 years) who screened positive for depression (Patient Health Questionnaire 9-item [PHQ-9] score ≥10) on 2 occasions or who screened positive and met criteria for major depression, spoke English, and had telephone access were recruited. Exclusions included alcohol/drug misuse, suicidal plan or recent attempt, bipolar disorder, developmental delay, and seeing a psychiatrist.InterventionsTwelve-month collaborative care intervention including an initial in-person engagement session and regular follow-up by master's-level clinicians. Usual care control youth received depression screening results and could access mental health services through Group Health.Main outcomes and measuresThe primary outcome was change in depressive symptoms on a modified version of the Child Depression Rating Scale-Revised (CDRS-R; score range, 14-94) from baseline to 12 months. Secondary outcomes included change in Columbia Impairment Scale score (CIS), depression response (≥50% decrease on the CDRS-R), and remission (PHQ-9 score <5).ResultsIntervention youth (n = 50), compared with those randomized to receive usual care (n = 51), had greater decreases in CDRS-R scores such that by 12 months intervention youth had a mean score of 27.5 (95% CI, 23.8-31.1) compared with 34.6 (95% CI, 30.6-38.6) in control youth (overall intervention effect: F2,747.3 = 7.24, P < .001). Both intervention and control youth experienced improvement on the CIS with no significant differences between groups. At 12 months, intervention youth were more likely than control youth to achieve depression response (67.6% vs 38.6%, OR = 3.3, 95% CI, 1.4-8.2; P = .009) and remission (50.4% vs 20.7%, OR = 3.9, 95% CI, 1.5-10.6; P = .007).Conclusions and relevanceAmong adolescents with depression seen in primary care, a collaborative care intervention resulted in greater improvement in depressive symptoms at 12 months than usual care. These findings suggest that mental health services for adolescents with depression can be integrated into primary care.Trial registrationclinicaltrials.gov Identifier: NCT01140464.

Project description:Importance:Nonadherence to antidepressant medication is common and leads to poor outcomes. Early nonadherence is especially problematic. Objective:To test the effectiveness of a psychosocial intervention to improve early adherence among older patients whose primary care physician newly initiated an antidepressant for depression. Design, Setting, and Participants:The Treatment Initiation and Participation Program (TIP) was offered in a 2-site randomized clinical effectiveness study between January 2011 and December 2014 at primary care practices in New York, New York, and Ann Arbor, Michigan. Analyses began in February 2016. All participants were middle-aged and older adults (aged ?55 years) who received newly initiated depression treatment by their primary care physician and recruited within 10 days of their prescription. Analyses were intention-to-treat. Interventions:Participants were randomly assigned to the intervention (TIP) or treatment as usual. Participants in the TIP group identified and addressed barriers to adherence, including stigma, misconceptions, and fears about treatment, before developing a personalized adherence strategy. The Treatment Initiation and Participation Program was delivered in three 30-minute contacts scheduled during a 6-week period just after the antidepressant was prescribed. Main Outcomes and Measures:The primary outcome was self-reported adherence on the Brief Medication Questionnaire, with adequate early adherence defined as taking 80% or more of the prescribed doses at 6 and 12 weeks. The secondary outcome was depression severity. Results:In total, 231 middle-aged and older adults (167 women [72.3%] and 64 men [27.7%]) without significant cognitive impairment were randomly assigned to the TIP intervention (n?=?115) or treatment as usual (n?=?116). Participants had a mean (SD) age of 67.3 (8.4) years. Participants in the TIP group were 5 times more likely to be adherent at 6 weeks (odds ratio,?5.54; 95% CI, 2.57 to 11.96; ?21?=?19.05; P?<?.001) and 3 times more likely to be adherent at both 6 and 12 weeks (odds ratio,?3.27; 95% CI, 1.73 to 6.17; ?21?=?13.34; P?<?.001). Participants in the TIP group showed a significant earlier reduction (24.9%) in depressive symptoms (95% CI, 13.9 to 35.9; t337?=?4.46; adjusted P?<?.001). In both groups, participants who were 80% adherent at weeks 6 and 12 had a 15% greater improvement in depressive symptoms from baseline over the course of treatment (95% CI, -0.2 to -30; t369?=?1.93; P?=?.051). Conclusions and Relevance:The Treatment Initiation and Participation Program is an effective intervention to improve early adherence to pharmacotherapy. Improved adherence can promote improvement in depression. Trial Registration:clinicaltrials.gov Identifier: NCT01301859.