We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reducing Depressive Symptomatology With a Smartphone App

This study is currently recruiting participants.
Verified July 2017 by Cezar Giosan, PhD, Babes-Bolyai University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03060200
First Posted: February 23, 2017
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Norwegian University of Science and Technology
CheckWare AS
Information provided by (Responsible Party):
Cezar Giosan, PhD, Babes-Bolyai University
  Purpose
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.

Condition Intervention
Moderate Depression Other: Self-administered online CBT plus therapist check in Other: Sham self-administered online CBT plus therapist check in

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Reducing Depressive Symptomatology With a Smartphone App: A Protocol for a Randomized, Placebo-Controlled Clinical Trial

Further study details as provided by Cezar Giosan, PhD, Babes-Bolyai University:

Primary Outcome Measures:
  • Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) (change from baseline) [ Time Frame: 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) ]
    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.


Secondary Outcome Measures:
  • The Positive and Negative Affect Scale (PANAS) (change from baseline) [ Time Frame: Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention) ]
    The Positive and Negative Affect Scale (PANAS) is a 20-item self-report questionnaire designed to assess mood. It consists of 10 items that address positive affect (PA) and 10 items that address negative affect (NA). Participants rate each item on a five-point Likert scale, from 1 (very slightly/not at all) to 5 (extremely). The PANAS can be used to assess mood on various time scales by altering the instructions. For the purposes of this study a two-week timeframe has been used. The validity and internal consistency of the PANAS are good, with test-retest reliability being the highest for the "general" temporal instruction. The PANAS has been used previously on the Romanian population and was found to have adequate psychometric properties.

  • The Behavioural Activation for Depression Scale - Short Form (BADS-SF)(change from baseline) [ Time Frame: 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) is an instrument designed to be administered weekly to measure changes in avoidance and activation over the course of the Behavioral Activation (BA) treatment for depression. The BADS consists of 9 items grouped into two subscales (Activation and Avoidance/Rumination). Respondents rate each item on a seven-point Likert scale ranging from 0 (not at all) to 6 (completely). The scale enjoys good psychometric properties. BADS-SF has been used previously on the Romanian population and was found to have adequate psychometric properties.

  • Satisfaction with Life (SWL) (change from baseline) [ Time Frame: Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention) ]
    Satisfaction with Life (SWL) is a five-item scale designed to measure global cognitive judgments of one's life satisfaction. Participants rate each of the 5 items using a seven-point scale that ranges from 7 (strongly agree) to 1 (strongly disagree). The SWL has been shown to be a valid and reliable measure of life satisfaction, which can be used with a wide range of age groups. SWL has been used previously on the Romanian population and was found to have adequate psychometric properties.


Other Outcome Measures:
  • The Dysfunctional Attitudes Scale Short Form (DAS-SF) (change from baseline) [ Time Frame: Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention) ]
    DAS was designed to measure the intensity of dysfunctional attitudes that, according to the cognitive theory of depression, contribute to vulnerability for depression. For the purpose of this study, the short form of this scale was used. The Dysfunctional Attitudes Scale-Short Form (DAS-SF) consists of two subscales: "dependency" (6 items) and "perfectionism/performance evaluation" (11 items). The 17 items are rated on a seven-point Likert scale, from 1 (total disagreement) to 7 (total agreement). DAS-SF possesses good psychometric properties in terms of model fit, reliability and convergent construct validity. DAS-SF has been used previously on the Romanian population and was found to have adequate psychometric properties.

  • The Beliefs Scale (BS) (change from baseline) [ Time Frame: Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention) ]
    The Beliefs Scale (BS) measures irrational beliefs. It consists of 20 items and responders indicate the level of agreement/disagreement with each item using a five-point Likert scale that ranges from 1 (strongly disagree) to 5 (strongly agree). The BS shows good psychometric properties regarding construct and discriminant validity. This scale has been used previously on the Romanian population and was found to have adequate psychometric properties.

  • The Automatic Thoughts Questionnaire (ATQ) (change from baseline) [ Time Frame: Baseline, mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline), Follow-up (3 months after post-intervention) ]
    he Automatic Thoughts Questionnaire (ATQ) is a 15-item self-report measure used to assess depression-related cognitions. Participants rate, on a five-point Likert scale from 1 (never) to 5 (almost all the time), the frequency of a given thought over the past week. A higher score shows a higher frequency of automatic thoughts. The psychometric properties of the ATQ have been adequately demonstrated in previous studies. The ATQ has been successfully used on the Romanian population before.

  • Satisfaction with the Application Scale [ Time Frame: Mid-intervention (3 weeks after baseline), post-intervention (6 weeks after baseline) ]
    Satisfaction with the Application Scale consists of 10 items that assess users' satisfaction with the application, its difficulty level, attractiveness, and subjective utility. The first 8 items are rated on a three-point scale, ranging from 0 to 2. Each response scale is personalized to the content of the item (e.g., How attractive did you find the exercises included in the application? - 0 = rather unattractive, 1 = attractive enough; 2 = very attractive). Item 9 assesses the application globally, with the participant being asked to give an overall grade between 1 (minimum) and 10 (maximum). Item 10 asks the participants if they would recommend the application to a friend ("yes" or "no" answer). This scale has been used previously by the same research team, in a study investigating the same mobile phone app.

  • The Application Use Scale [ Time Frame: 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) ]
    The Application Use Scale consists of 8 items that assess weekly quantitative app usage aspects: the effort invested in homework (1 item), number of practiced exercises (1 item), number of read courses (1 item), frequency of general application use (1 item), and frequency of every exercise use (4 items). This scale has been used previously by the same research team, in a study investigating the same mobile phone app.


Estimated Enrollment: 220
Actual Study Start Date: February 17, 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active intervention
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
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.
No Intervention: Waiting list
Moderately depressed participants will be put on a wait list for 6 weeks, after which access to the depression app will be given.
Placebo Comparator: Placebo
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
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060200


Contacts
Contact: Cezar Giosan, PhD +1212-444-8577 giosan@outlook.com
Contact: Oana Cobeanu, PhD 0040730439047 oana.cobeanu@ubbcluj.ro

Locations
Romania
Babeș-Bolyai University Recruiting
Cluj-Napoca, Cluj, Romania, 400084
Contact: Oana Cobeanu, PhD    0040730439047    oana.cobeanu@ubbcluj.ro   
Principal Investigator: Cezar Giosan, PhD         
Sponsors and Collaborators
Babes-Bolyai University
Norwegian University of Science and Technology
CheckWare AS
Investigators
Principal Investigator: Cezar Giosan, PhD Babeș-Bolyai University
  More Information

Additional Information:
Responsible Party: Cezar Giosan, PhD, PhD, Babes-Bolyai University
ClinicalTrials.gov Identifier: NCT03060200     History of Changes
Other Study ID Numbers: EEA-JRP-RO-NO-2013-1-0358/2
First Submitted: February 1, 2017
First Posted: February 23, 2017
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cezar Giosan, PhD, Babes-Bolyai University:
depression
treatment
CBT
online
app

Additional relevant MeSH terms:
Depression
Behavioral Symptoms