Reducing Depressive Symptomatology With a Smartphone App
Reducing Depressive Symptomatology With a Smartphone App
The aim of this study is to test a newly developed app, firmly grounded in Cognitive
 Behavioural Therapy (CBT) theory of depression, to determine primarily if this app is
 clinically useful in decreasing moderate depressive symptoms when compared with an active
 placebo. Additionally, we are interested in the app's potential to contribute to the
 reduction of general negative affect, increasing positive affect, and boosting satisfaction
 with life. Last, but not least, we aim to verify if the usage of the tested app can modify
 depressogenic cognitions.
Trial design This study is a randomized, placebo-controlled trial, examining the effects of a
 CBT intervention in reducing depressive symptomatology for people with moderate symptoms.
 Participants are randomly assigned to one of the 3 arms of the trial: (1) CBT intervention;
 (2) placebo intervention (PI); and (3) delayed intervention (wait-list; WL). Major
 assessments are at baseline, post-treatment, and follow-up 12 weeks later. Participants
 randomized to the PI and WL trial arms are offered access to the online app upon completion
 of the study. Participants are blinded to hypotheses and the nature of the placebo
 intervention, but they are informed they have a 1 in 3 chance of being assigned to the
 placebo intervention.

 Participant timeline Potential participants will be assessed for eligibility through an
 initial assessment of depressive symptoms. The initial assessment phase consists of
 administration of the Patient Health Questionnaire-9 (PHQ-9) and a short screening telephone
 interview. Applicants who do not meet the inclusion criteria are informed via e-mail. They
 are given a summary score and interpretation for their PHQ-9 score and they are encouraged to
 discuss their problems with a professional, if necessary. Information on how to reach one - a
 clinical psychologist or psychotherapist - is also provided. Subsequent assessments consist
 of all the instruments presented in the Outcome measures section. After the initial
 assessment, the participants meeting inclusion criteria will be randomly assigned to one of
 the three conditions: active intervention condition (Group 1), the placebo intervention
 (Group 2), and the delayed-intervention condition (wait-list) (Group 3).

 The participants in the active intervention and active placebo conditions are assessed at
 pre-intervention (Time 1 - baseline), at mid-intervention (Time 2 - 3 weeks after baseline),
 at post-intervention (Time 3 - 6 weeks after baseline), and at 3-months post-intervention
 (Time 4). The participants in the delayed-intervention condition are assessed before the
 waiting period (Time 1 - baseline), at mid-waiting period (Time 2 - 3 weeks after baseline),
 and at post-waiting period (Time 3 - 6 weeks after baseline).

 Participants assigned to the active intervention condition will be given access to the online
 application along with explicit instructions regarding the use of all of its sections.
 Participants will be given 6 weeks to complete the intervention, during which time weekly
 messages will be sent out to them. Messages include regular assignments designed for a
 complete and thorough use of the application's courses and exercises, and encourage the
 review of materials whenever possible. However, participants are free to use the application
 at their own pace.

 Similarly, the participants in the active placebo condition will be given given access to a
 sham version of the app. During the 6-week intervention period they will be exposed to the
 same amount of online (i.e., in app messages) and therapist communication as the active
 intervention participants.

 After each week, participants' application use is evaluated (see the Application Use Scale
 described above). Similarly, after each week of using the application, the participants are
 required to complete the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R),
 for close monitoring of their depressive symptomatology and individualized feedback on their
 emotional state.

 Participants in the delayed intervention condition are placed on a wait-list for 6 weeks,
 after which they are given access to the app.

 Sample size A total number of 165 participants with moderate depressive symptomatology was
 estimated based on previous studies on the efficacy of mobile phone applications for
 depression that reported small to moderate between group effect sizes. An a priori sample
 size calculation was conducted with G*Power 3.1.9.2 for ANOVA (Repeated measures, between
 factors), assuming an alpha level of 0.05, a statistical power of 0.80, and a small to medium
 effect size (f = 0.2). Based on the fact that the current protocol has a therapist check-in
 component, a sample size recruitment target of n = 220 was set to allow for sample attrition,
 thus estimating a drop-out rate of approximately 30%.

 Recruitment Possible participants are approached through ads on a social network. Those
 interested in using the application are asked to access the study's website and follow the
 standard recruitment procedure. They are subsequently contacted via a telephone call, at
 which point the enrollment procedure is described.

 Assignment to study group The participants are randomly assigned to one of the three trial
 arms, using the software Randomizer.org. Randomization is performed by a research assistant
 using a simple (unrestricted) randomization sequence that assigns three unique numbers per
 participant; the number assigned is either 1, 2, or 3 according to the number of the
 experimental conditions. To conceal the allocation mechanism, the same research assistant
 will monitor the assessments and allow access to the application for the participants in the
 waitlist control group, after 6 weeks. The principal investigator and the statisticians
 running the data analysis will remain blinded to the study condition until the completion of
 the study.

 Monitoring study implementation. Three clinical psychologists, members of the study team,
 screen for the risk of unintended effects or harm to the participants (i.e., clinically
 significant increase in depressive symptomatology, as measured by the CESD-R). The
 psychologists also monitor the weekly online evaluations and clinically interpret the CESD-R
 score of every participant. If the participant does not complete the CESD-R evaluation, a
 telephonic contact follows. If necessary, the supervisor can decide to interrupt the
 participant's access to the application and make a further referral.
Inclusion Criteria:

 -  Romanian-speaking adults (18 years or older)

 -  Access to a computer, a smartphone (Android or iOS) and Internet

 -  A PHQ-9 score between 10 and 16

 Exclusion Criteria:

 -  Undergoing treatment - medication and/or psychotherapy

 -  Substance abuse problems

 -  Psychotic symptoms

 -  Organic brain disorders (e.g., dementia)

 -  Self-injury or harming others

 -  Serious legal or health issues that would prevent from using the app

 -  Reporting scores larger than 1 to Question 9 (suicidal ideation) on the (PHQ-9)