Using a Smartphone App to Reduce Cognitive Vulnerability and Mild Depressive Symptoms
Condition: Mild Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Depression is one of the major challenges worldwide, with significant increasing personal,
      economic, and societal costs. Although empirically supported treatments have been developed,
      they are not always available for patients in routine clinical care. Even when patients are
      adequately treated, they do not always respond to treatment and/or face a significant risk
      for recurrence. Therefore, effective and wide accessible strategies to prevent the onset of
      the very first depressive symptoms are necessary. Mental health apps could prove a valuable
      alternative for that. Although preliminary research has indicated that apps could be useful
      in treating depression, no study has attempted to test their utility in preventing depression
      symptoms. The current study aims to contrast the efficacy of a smartphone app in preventing
      depression compared against a waiting list condition. The app includes self-help materials
      and exercises based on cognitive behavioral therapy (CBT) for depression, presented in a
      tailored manner and incorporating gamification elements aimed at boosting the motivation to
      use the app.

      This study protocol is the first that capitalizes on the ubiquity of smartphones to
      large-scale dissemination of CBT-based strategies aimed at preventing depression in
      nonclinical populations. The objective of this study is to test an app designed to decrease
      general cognitive vulnerability and promote engagement in protective, adaptive activities,
      while counteracting the tendency of premature dropout (through gamification and
      customization).
    

Detailed description: 
      Trials design. This study will include two parallel-randomized trials, with pre-post
      measurements. The designs of the trials will be similar and compliant with the CONSORT
      guidelines. In the first trial the efficacy of the preventative version of the application
      will be tested against a wait list control group, in a healthy sample of participants. In the
      second trial the efficacy of the app will be tested against a wait list control group, in a
      sample of participants with mild depressive symptoms.

      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 PHQ-9 and a short screening telephone interview. 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 two conditions: immediate online intervention condition (Group 1) or the
      delayed-intervention condition (wait-list) (Group 2).

      Participants assigned to Group 1 will be given access to the online application along with
      explicit instructions regarding the use of all of its sections. Participants will be given 4
      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.

      Participants in the delayed intervention group (Group 2) are placed on a wait-list for 4
      weeks.

      Sample size. A a total number of 50 participants per study (i.e., 50 participants without
      depressive symptomatology, and 50 participants with mild depressive symptomatology) was
      estimated based on previous studies testing mobile phone applications for depression that
      reported large within group effect sizes. The calculation of the sample size was conducted
      with G*Power 3.1. for ANOVA (Repeated measures, between factors), assuming an alpha level of
      0.05, a statistical power of 0.80, and a large effect size (Cohen's f = 0.355).

      Recruitment. Possible participants are approached through presentations at various events and
      ads in the media. Those interested in using the application are asked to provide their
      contact details and are subsequently contacted via e-mail, at which point the enrollment
      procedure is described. Initially, possible participants are invited to access the study's
      website and, after carefully reading the information package and informed consent,
      instructions to create an online account are given. The participants are then asked to answer
      a few demographic questions and complete the PHQ-9, to determine their eligibility for
      further evaluation. If eligible, a screening procedure is implemented. A short telephone
      interview screens out individuals whose participation in the study is motivated by problems
      other than their mood. Applicants who do not meet the inclusion criteria are informed via
      e-mail, thanked for their interest, given a summary score and interpretation for their PHQ-9
      score. Applicants 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. Licensed, certified clinical psychologists recruit prospective participants into
      the study. Media avenues (e.g., social networks, dedicated websites) are used for recruitment
      purposes. Additionally, clinicians from the private practice area are contacted for
      referrals.

      Assignment to study group. The participants are assigned to one of the two trials, depending
      on their depressive symptomatology level (i.e., PHQ-9 score). Using the software
      Randomizer.org, participants are then randomly distributed to one of the trials' conditions.
      Randomization is performed by a research assistant using a simple (unrestricted)
      randomization sequence that assigns two unique numbers per participant; the number assigned
      is either 1 or 2, 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 delayed intervention condition (Group
      2), after 1 month. 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. Two 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
Intervention type(s): Other
Intervention description(s): The app being tested has two main components: courses and exercises. Courses represent the psycho-educational and therapeutic background of the program, comprising the following topics: information on depression, psychological vulnerability, what is CBT, healthy and unhealthy negative emotions, rational and irrational thoughts, how behaviors contribute to depression, sleep hygiene, social support, and relaxation techniques. Exercises use the information presented in the courses and follow the structure of a regular therapy session and/or therapeutic homework.
The following exercises are included in the app:
The Emotional Pulse exercise
The Sticky Notes exercise
The Find Irrational Thoughts
The Change Irrational Thoughts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Depression; Prevention; CBT; Smartphone app