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Using a Smartphone App to Reduce Cognitive Vulnerability and Mild Depressive Symptoms

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ClinicalTrials.gov Identifier: NCT02783118
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Cezar Giosan, PhD, Babes-Bolyai University

Brief 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).


Condition or disease Intervention/treatment Phase
Mild Depression Other: Self administered online CBT Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Using a Smartphone App to Reduce Cognitive Vulnerability and Mild Depressive Symptoms: An Exploratory Study Protocol for a Randomized Controlled Trial
Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy sample, active intervention
Healthy participants will be testing a depression prevention app employing a self administered online CBT intervention, for 4 weeks.
Other: Self administered online CBT

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:

  1. The Emotional Pulse exercise
  2. The Sticky Notes exercise
  3. The Find Irrational Thoughts
  4. The Change Irrational Thoughts

No Intervention: Healthy sample, delayed intervention
Healthy participants will be put on a wait list for 4 weeks, after which access to the depression prevention app will be given.
Experimental: Mild depression, active intervention
Mildly depressed participants will be testing a depression prevention app, employing a self administered online CBT intervention, for 4 weeks.
Other: Self administered online CBT

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:

  1. The Emotional Pulse exercise
  2. The Sticky Notes exercise
  3. The Find Irrational Thoughts
  4. The Change Irrational Thoughts

No Intervention: Mild depression, delayed intervention
Mildly depressed participants will be put on a wait list for 4 weeks, after which access to the depression prevention app will be given.



Primary Outcome Measures :
  1. 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, post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.) ]
    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 adapted to Romanian for the purposes of the current study.

  2. The Dysfunctional Attitudes Scale Short Form (DAS-SF) (change from baseline) [ Time Frame: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.) ]
    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 adapted to Romanian for the purposes of this study.

  3. The Beliefs Scale (BS) (change from baseline) [ Time Frame: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.) ]
    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 translated into Romanian for the purposes of this study.

  4. The Automatic Thoughts Questionnaire (ATQ) (change from baseline) [ Time Frame: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.) ]
    The 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.


Secondary Outcome Measures :
  1. The Positive and Negative Affect Scale (PANAS) (change from baseline) [ Time Frame: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.) ]
    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.

  2. Satisfaction with Life (SWL) (change from baseline) [ Time Frame: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.) ]
    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 adapted to Romanian for the purposes of the current study.


Other Outcome Measures:
  1. The Behavioural Activation for Depression Scale - Short Form (BADS-SF) (change from baseline) [ Time Frame: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.) ]
    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 translated into Romanian for the purposes of this study.

  2. Satisfaction with the Application Scale [ Time Frame: Post-intervention (4 weeks after baseline) ]
    Satisfaction with the Application Scale was specifically designed for this study. It 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).

  3. The Application Use Scale (change from baseline) [ Time Frame: 1 week after baseline, 2 weeks after baseline, 3 weeks after baseline, 4 weeks after baseline ]
    The Application Use Scale was also developed specifically for this study. It 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Romanian-speaking adults (18 years or older)
  • Access to a computer, a smartphone (Android or iOS) and Internet
  • A Patient Health Questionnaire-9 (PHQ-9) score of 4 or below (for the healthy participants sample)
  • A PHQ-9 score no greater than 9 (for the mildly depressed participants sample)

Exclusion Criteria:

  • Undergoing therapy
  • 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)

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): NCT02783118


Locations
Romania
Babes-Bolyai University
Cluj-Napoca, Cluj, Romania, 400084
Sponsors and Collaborators
Babes-Bolyai University
Investigators
Principal Investigator: Cezar Giosan, PhD Babes-Bolyai University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cezar Giosan, PhD, Principal Investigator, PhD, Babes-Bolyai University
ClinicalTrials.gov Identifier: NCT02783118     History of Changes
Other Study ID Numbers: EEA-JRP-RO-NO-2013-1-0358/1
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cezar Giosan, PhD, Babes-Bolyai University:
Depression
Prevention
CBT
Smartphone app

Additional relevant MeSH terms:
Depression
Behavioral Symptoms