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Reducing Depressive Symptomatology With a Smartphone App

NCT03060200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2019-07-16

No results posted yet for this study

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.

Conditions

  • Moderate Depression

Interventions

OTHER

Self-administered online CBT plus therapist check in

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.

OTHER

Sham self-administered online CBT plus therapist check in

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.

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • CheckWare AS

    collaborator UNKNOWN

  • Babes-Bolyai University

    lead OTHER

Principal Investigators

  • Cezar Giosan, PhD · Babeș-Bolyai University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-17
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03060200 on ClinicalTrials.gov