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Depression is the most prevalent mental health problem. The need for effective treatments for depression far outstrips the availability of trained mental health professionals. Smartphones and other widely available technologies are increasingly being leveraged to deliver treatments for depression. Whether there are patient characteristics that affect the potency of smartphone interventions for depression is not well understood.
This study aimed to evaluate whether patient characteristics including clinical diagnosis, depression severity, psychosis status, and current use of antidepressant medications impact the effects of an evidence-based smartphone intervention on depressive symptoms.
Data were collected as part of a 2-arm randomized controlled trial comparing a multimodal smartphone intervention called FOCUS with a clinic-based intervention. Here, we report on 82 participants assigned to 12 weeks of FOCUS treatment. We conducted assessments of depressive symptoms using the Beck Depression Inventory-second edition (BDI-II) at baseline, postintervention (3 months), and follow-up (6 months). We tested for differences in the amount of improvement in BDI-II scores from baseline to posttreatment and 6-month follow-up between each of the following patient subgroups using 2 (group) × 2 (time) mixed effects models: diagnosis (ie, schizophrenia spectrum disorder vs bipolar disorder vs major depressive disorder), depression severity (ie, minimal-mild vs moderate-severe depression), psychosis status (ie, presence vs absence of psychotic symptoms), and antidepressant use (ie, taking antidepressants vs not taking antidepressants).
The majority of participants were male (60%, 49/82), African American (65%, 53/82), and middle-aged (mean age 49 years), with a high school education or lower (62%, 51/82). There were no differences in patient demographics across the variables that were used to stratify the analyses. There was a significant group × time interaction for baseline depression severity (
Our results suggest that FOCUS can be deployed to treat moderate to severe depressive symptoms among people with schizophrenia spectrum disorders, bipolar disorder, and major depressive disorder, in concert with antidepressant medications or without them, in both people with and without active psychotic symptoms. The study results are consistent with research on transdiagnostic models in psychotherapy and extend our knowledge about the potential of transdiagnostic mobile health.
ClinicalTrials.gov NCT02421965; http://clinicaltrials.gov/ct2/show/NCT02421965 (Archived by WebCite at http://www.webcitation.org/76pyDlvAS)
Depression is a universal experience. Symptoms of depression are the most common mental health concern reported across nationalities, ethnicities, and age groups worldwide [
It is only fitting that in recent years the most common mental health problem is starting to be addressed with the aid of one of the most widely used technologies on the planet: the mobile phone [
Given that depressive symptoms commonly emerge in many forms of psychopathology [
We conducted an assessor-blind, 2-arm, RCT between 2015 and 2017. The project was conducted in partnership with a large Chicago-based mental health agency that provides services to a range of people with psychiatric conditions. The study was approved by the Institutional Review Boards of the University of Washington and Dartmouth College and monitored continuously by an independent safety monitoring board. All study participants completed informed consent. Individuals were randomized (1:1 ratio) into 1 of the 2 treatment arms: an mHealth intervention delivered via smartphone (FOCUS) or a clinic-based group intervention (Wellness Recovery Action Plan). Interventions were deployed for a period of 12 weeks. We conducted assessments at baseline, postintervention (3 months), and follow-up (6 months). Participants were compensated $30 per assessment. The study was registered in ClinicalTrials.gov, and the main RCT comparison outcomes were reported in an earlier publication [
FOCUS is a multimodal, smartphone-delivered intervention that was originally designed to support the recovery of people with schizophrenia [
A total of 82 participants who were assigned to the FOCUS smartphone arm in the RCT are included in this report; posttreatment and 6-month follow-up data were available for 75 (91.5%) and 74 (90.2%) participants, respectively. Participants were identified by research staff and clinical teams at 3 agency sites. Study inclusion criteria included the following: chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder; aged 18 years or older; and a rating of “3” or lower on 1 of the 3 items comprising the
The primary outcome (depression symptoms) was measured with the Beck Depression Inventory-second edition (BDI-II) [
We conducted a series of 2 (group) × 2 (time) mixed effects models to evaluate whether there were differences in the amount of clinical improvement in BDI-II scores between each of the following groups: (1) Diagnosis, schizophrenia spectrum disorder versus bipolar disorder versus major depressive disorder; (2) Depression severity, minimal-mild versus moderate-severe depression; (3) Psychosis symptoms, presence versus absence of psychotic symptoms, and (4) Antidepressant medications, taking antidepressants versus not taking antidepressants. Any significant group × time interactions would indicate that the amount of clinical improvement was moderated by the baseline group variable; interactions that were significant were followed by paired sample
Descriptive statistics are presented in
Descriptive statistics at baseline (N=82).
Demographic and study variables | Statistics | |
Age (years), mean (SD) | 49 (10.1) | |
Male, n (%) | 49 (60) | |
Previously used smartphone, n (%) | 60 (73) | |
White | 22 (27) | |
African American | 53 (65) | |
Other or more than 1 race | 7 (9) | |
High school or less | 51 (62) | |
More than high school | 31 (38) | |
Schizophrenia/schizoaffective disorder | 38 (46) | |
Bipolar disorder | 21 (26) | |
Major depressive disorder | 23 (28) | |
Minimal or mild | 35 (43) | |
Moderate or severe | 47(57) | |
Absent | 51 (62) | |
Present | 31 (38) | |
None | 34 (41) | |
One or more | 46 (56) | |
Unknown | 2 (2) |
As was also reported in the parent trial [
Changes in BDI-II edition depression scores by patient characteristics at baseline. BDI-II: Beck Depression Inventory-second edition.
The results of this study deepen our understanding of patient clinical characteristics that may impact the effectiveness of FOCUS on their level of depression, independent of their assigned diagnostic label. We found that (1) FOCUS produced significant and sustained (at 6-month follow-up) reduction in depression among people who had moderate to severe depressive symptoms, effects that were not seen among people with minimal to mild depressive symptoms; (2) FOCUS produced significant and sustained reductions in depression among people with schizophrenia/schizoaffective disorder, bipolar disorder, and major depressive disorder; (3) FOCUS produced significant and sustained reductions in depression among people with psychotic symptoms and among people without any indication of psychosis; and (4) FOCUS produced significant and sustained reduction in depression in both people who were taking antidepressant medications and people who were not.
Our findings suggest that FOCUS might be a useful intervention to address moderate to severe depressive symptoms among individuals with an array of mental illnesses. Depressive symptoms are common among people experiencing psychosis [
In the context of precision medicine in mental health care [
The study has several limitations. First, because mHealth was adjunctive to existing service provided through the community agency, other services may also have contributed to the positive changes that occurred during the study period. Second, the original study was designed with sufficient power to detect treatment changes in the overall sample, and thus, the subgroup analyses presented here should be interpreted with caution. Finally, dichotomous groups based on baseline variables were broad; a larger sample would allow examination of more fine-grained or continuous relationships between demographic or clinical characteristics and treatment benefit.
FOCUS was designed to maximize accessibility for those who are most impaired [
Beck Depression Inventory-second edition
mobile health
Psychotic Symptom Rating Scales
randomized controlled trial
The authors would like to thank the staff and members of Thresholds in Chicago for participating and contributing to the study.
DB-Z consults for eQuility and has had an intervention content licensing agreement with Pear Therapeutics. KH has provided consultation to Pear Therapeutics.