Reducing Depressive Symptomatology With a Smartphone App

NCT03060200 | Completed

• 1 other identifier: EEA-JRP-RO-NO-2013-1-0358/2
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

depression; treatment; CBT; online; app

Outcome Measures

Primary Outcomes (1)

• Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) (change from baseline)

  The CESD-R is a 20-item self-report instrument, which measures symptoms of depression in nine different groups: sadness (dysphoria), loss of interest (anhedonia), appetite, sleep, thinking/concentration, guilt (worthlessness), tired (fatigue), movement (agitation), and suicidal ideation. Participants rate each item on a five-point Likert scale, from 0 (not at all or less than one day) to 4 (nearly every day for 2 weeks) and refer to a time frame of a week or so. The Total CESD-R Score is calculated as a sum of responses to all 20 questions. The CESD-R exhibited good psychometric properties, including high internal consistency, strong factor loadings, and theoretically consistent convergent and divergent validity with anxiety, schizotypy, and positive and negative affect. CESD-R has been used previously on the Romanian population and was found to have adequate psychometric properties.

  Baseline, 1 week after baseline, 2 weeks after baseline, 3 weeks after baseline, 4 weeks after baseline, 5 weeks after baseline, post-intervention (6 weeks after baseline), Follow-up (3 months post-intervention)

Secondary Outcomes (3)

• The Positive and Negative Affect Scale (PANAS) (change from baseline)

  Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention)

• The Behavioural Activation for Depression Scale - Short Form (BADS-SF)(change from baseline)

  Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention)

• Satisfaction with Life (SWL) (change from baseline)

  Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention)

Other Outcomes (5)

• The Dysfunctional Attitudes Scale Short Form (DAS-SF) (change from baseline)

  Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention)

• The Beliefs Scale (BS) (change from baseline)

  Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention)

• The Automatic Thoughts Questionnaire (ATQ) (change from baseline)

  Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention)

Study Arms (3)

Active intervention

EXPERIMENTAL

Self-administered online CBT plus therapist check in. Moderately depressed participants will be testing a depression app, employing a self administered plus therapist check in, online CBT intervention, for 6 weeks.

Other: Self-administered online CBT plus therapist check in

Waiting list

NO INTERVENTION

Moderately depressed participants will be put on a wait list for 6 weeks, after which access to the depression app will be given.

Placebo

PLACEBO COMPARATOR

Sham self-administered online CBT plus therapist check in. Moderately depressed participants will be using a depression app - the same platform and largely in the same format as the tested app, employing a self administered plus therapist check in, online sham intervention, for 6 weeks. The intervention will include the same sections and features as the original app, except for the complete exercises and behavioral activation sections. 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 information on psychological well being.

Other: Sham self-administered online CBT plus therapist check in

Interventions

Self-administered online CBT plus therapist check in OTHER

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.

Active intervention

Sham self-administered online CBT plus therapist check in OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Babes-Bolyai University: lead
• Norwegian University of Science and Technology: collaborator
• CheckWare AS: collaborator

Study Sites (1)

Babeș-Bolyai University

Cluj-Napoca, Cluj, 400084, Romania

Location

Related Publications (1)

• Giosan C, Cobeanu O, Mogoase C, Szentagotai A, Muresan V, Boian R. Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial. Trials. 2017 May 12;18(1):215. doi: 10.1186/s13063-017-1960-1.

  PMID: 28494802 DERIVED

Related Links

• Study description and recruitment link

MeSH Terms

Conditions

Depression; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Cezar Giosan, PhD

  Babeș-Bolyai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 23, 2017
• Study Start: February 17, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)