Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.

NCT04988529 | Unknown DMC

• 1 other identifier: SERGAMIN/278
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present project is to study the effect of a smartphone-based serious game intervention for depressive symptoms. The serious game is based on Cognitive Behavior Therapy CBT, being behavioural activation and the promotion of physical activity one of the most important components.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (5)

• Patient Health Questionnaire-9 (PHQ-9)

  The PHQ-9 is the depression module of the self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 consists of 9 items ranging from "0" (not at all) to "3" (nearly every day). It has a dual-purpose instrument since it can establish both depressive disorder diagnoses and grade depressive symptom severity. Scores can range from zero to 27. Scores of 15 or greater indicated major depression.

  Up to 12 months

• Beck Depression Inventory (BDI-II)

  The BDI-II is widely used to detect and assess the severity of depressive symptoms. The BDI-II consists of 21 multiple-choice items ranging from 0 to 3. It covers the different symptoms of major depression disorder in the DSM-IV. Scores can range from zero to 63. Scores greater than 29 mean major depression. The BDI-II has high internal consistency (alpha = 0.76 to 0.95) and for the Spanish version (alpha = 0.89) (Sanz, 2003)

  Up to 12 months

• Positive and negative emotionality Positive and Negative Affect Scale (PANAS)

  The PANAS is used to measure trait and state affectivity. The PANAS consists of 20 items divided in two independent 10-item dimensions to assess positive affect (PA) and negative affect (NA). Each item rated on a 5-point Likert-type scale. Low levels of PA predict the onset depreesion, reduce positive emotions, and increase the severity of depressive symptoms.Patients with more comorbid diagnoses had significantly higher NA and lower PA. It is brief, reliable, and has shown excellent internal consistency (alpha = 0.84 to 0.90) and convergent and divergent validity. The Spanish version has also shown high internal consistency (alpha = 0.87 and 0.89 for PA and NA in men, respectively, and alpha = 0.89 and 0.91 for PA and NA in women, respectively (Díaz-García, 2020).

  Up to 12 months

• Overall Anxiety Severity and Impairment Scale (OASIS)

  The OASIS is used to assess the severity and frequency of anxiety symptoms. Moreover, the scale provides information about behavioral avoidance and functional impairments in pleasurable activities, work, school or social relationship interference related to these symptoms in the last week. The OASIS consists of a 5-item self-report measure rated from 0 to 4 and are summed to obtain one total score. OASIS score of 8 or above would be indicative of a probable anxiety disorder. It has demonstrated strong psychometric properties with good internal consistency (alpha = 0.86), as well as test-retest reliability (K = 0.82) and convergent validity (Norman, 2006; Campbell-Sill, 2009; Norman, 2011).

  Up to 12 months

• Overall Depression Severity and Impairment Scale (ODSIS)

  The ODSIS is used to assess the severity and frequency of depressive symptomatology and functional deficits in pleasurable activities due to the depressive symptomatology. The ODSIS consists of a 5-item self-report measure rated from 0 to 4 with higher scores indicating greater depression-related severity and impairment. It has excellent internal consistency (alpha = 0.92) and it shows good convergent/discriminant validity (Bentley, 2014) Spanish version will be used (Mira, 2019

  Up to 12 months

Secondary Outcomes (2)

• System Usability Scale (SUS)

  Up to 12 months

• Expectation of treatment scale and opinion of treatment scale (CEQ)

  Up to 12 months

Study Arms (2)

Smartphone-based supported serious game intervention

EXPERIMENTAL

Group that receives the smartphone-based serious game intervention and receives technical support

Behavioral: Smartphone-based serious game intervention

Waiting list control

NO INTERVENTION

Group that does not receive any treatment

Interventions

Smartphone-based serious game intervention BEHAVIORAL

Smartphone-based serious game intervention consists in the use of a serious game designed specifically to improve depressive symptoms. The psychological content consists of CBT intervention with the following psychotherapeutic components: Motivation for change, Psychoeducation, Cognitive Flexibility, Behavioural Activation, and positive psychotherapeutic strategies. To encourage physical activity, the serious game incorporates a mixed reality through physical activities such as taking a walk in real life affects aspects inside the game.

Smartphone-based supported serious game intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Being able to read and understand Spanish
• Being able to use a smartphone
• Having an Android smartphone with internet connection
• Suffering from mild to moderate depressive symptoms (from 14 to 28 on the Beck Depression Inventory-II \[BDI-II\]

You may not qualify if:

• Suffering a severe mental disorder: bipolar disorder, alcohol and/ or substance dependence disorder, psychotic disorder, or dementia
• Having a high suicide risk (ideation or plan assessed by the MINI and item 9 of the BDI-II)
• Receiving another psychological treatment while the study is still ongoing.

Sponsors & Collaborators

• Universitat Jaume I: lead
• Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital.: collaborator

Study Sites (1)

University Jaume I

Castellon, Castelló, 12006, Spain

Location

Related Links

• Information about GEOTEC, the technical research group of the University Jaume I
• Information about the Laboratory of Psychology and Technology of the University Jaume I

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Sven Casteleyn, Professor

CONTACT

+34964387693; sven.casteleyn@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 3, 2021
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)