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

NCT02783118 | Completed

• 1 other identifier: EEA-JRP-RO-NO-2013-1-0358/1
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Depression

Keywords

Depression; Prevention; CBT; Smartphone app

Outcome Measures

Primary Outcomes (4)

• 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 adapted to Romanian for the purposes of the current study.

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

  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.

  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) (change from baseline)

  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.

  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) (change from baseline)

  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.

  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.)

Secondary Outcomes (2)

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

  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) (change from baseline)

  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.)

Other Outcomes (3)

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

  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 the Application Scale

  Post-intervention (4 weeks after baseline)

• The Application Use Scale (change from baseline)

  1 week after baseline, 2 weeks after baseline, 3 weeks after baseline, 4 weeks after baseline

Study Arms (4)

Healthy sample, active intervention

EXPERIMENTAL

Healthy participants will be testing a depression prevention app employing a self administered online CBT intervention, for 4 weeks.

Other: Self administered online CBT

Healthy sample, delayed intervention

NO INTERVENTION

Healthy participants will be put on a wait list for 4 weeks, after which access to the depression prevention app will be given.

Mild depression, active intervention

EXPERIMENTAL

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

Mild depression, delayed intervention

NO 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.

Interventions

Self administered online CBT OTHER

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

Healthy sample, active intervention; Mild depression, active intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, 400084, Romania

Location

Related Publications (5)

• Cuijpers P, Beekman AT, Reynolds CF 3rd. Preventing depression: a global priority. JAMA. 2012 Mar 14;307(10):1033-4. doi: 10.1001/jama.2012.271. No abstract available.

  PMID: 22416097 BACKGROUND

• Munoz RF, Beardslee WR, Leykin Y. Major depression can be prevented. Am Psychol. 2012 May-Jun;67(4):285-95. doi: 10.1037/a0027666.

  PMID: 22583342 BACKGROUND

• Buntrock C, Ebert DD, Lehr D, Smit F, Riper H, Berking M, Cuijpers P. Effect of a Web-Based Guided Self-help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression: A Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1854-63. doi: 10.1001/jama.2016.4326.

  PMID: 27139058 BACKGROUND

• Birney AJ, Gunn R, Russell JK, Ary DV. MoodHacker Mobile Web App With Email for Adults to Self-Manage Mild-to-Moderate Depression: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2016 Jan 26;4(1):e8. doi: 10.2196/mhealth.4231.

  PMID: 26813737 BACKGROUND

• Giosan C, Mogoase C, Cobeanu O, Szentagotai Tatar A, Muresan V, Boian R. Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial. Trials. 2016 Dec 28;17(1):609. doi: 10.1186/s13063-016-1740-3.

  PMID: 28031038 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Cezar Giosan, PhD

  Babes-Bolyai University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 26, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)