Reducing Depressive Symptomatology With a Smartphone App
Condition: Moderate Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Self-administered online CBT plus therapist check in; Sham self-administered online CBT plus therapist check in
Intervention type(s): Other; Other
Intervention description(s): The app being tested is comprised of courses, exercises and a behavioural activation component. Courses represent the psycho-educational background of the program, comprising topics such as: information on depression, what is CBT, healthy/unhealthy negative emotions, rational/irrational thoughts, behaviour, social support, relaxation techniques, sleep hygiene, relapse prevention, treatment adherence, and suicide prevention plan. Exercises use the information presented in the courses and follow the structure of a regular therapy session/ therapeutic homework. The following exercises are included in the app: Emotional Pulse, Find Irrational Thoughts, and Change Irrational Thoughts. The behavioural activation component consists in two main exercises: My goals and My Activities.; The active placebo intervention will be delivered via the same platform and largely in the same format as the tested app: it will include the same sections and features as the original app, except for the complete exercises. In addition, the psychoeducation section, although mirroring the structure of the corresponding section in the original app, will include different content, elaborating on common sense psychological well being aspects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: depression; treatment; CBT; online; app