Mild Depression Clinical Trial
Official title:
Using a Smartphone App to Reduce Cognitive Vulnerability and Mild Depressive Symptoms: An Exploratory Study Protocol for a Randomized Controlled Trial
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).
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.
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