Online Positive Psychology Intervention for Depression and Anxiety Due to COVID-19

NCT04468893 | Completed DMC

• 1 other identifier: VIU-PP
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of a Positive Psychology intervention, that is focused on increasing the positive emotions and strengths of human beings. It is compared to the effectiveness of an online treatment with the change of the same participants before and after receiving the treatment accompanied by a chat support service vs. the treatment solely. The changes are being assessed through worldwide validated measures such as psychometrics.

Conditions

Anxiety; Depression; Sleep Disturbance

Outcome Measures

Primary Outcomes (6)

• Decrease in the score of Anxiety symptoms

  The State/Trait Anxiety Inventory consists of two subscales of 20 items each that measure anxiety as a transient state of tension (Scale A-State), and as a characteristic of the personality relatively stable over time (Scale B -trait). The items are composed by an assertion to which the subject responds indicating their degree of identification. In the case of state anxiety, the scale goes from 1 (not at all), 2 (somewhat), 3 (moderately), 4 (very much), while in the trait anxiety it ranges from 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). In both, a percentage of the items evaluate well-being or absence of anxiety, while the rest of the items to the presence of anxiety. Scores range from 20 to 80, in each subscale, with higher scores correlating with greater anxiety. It is expected a statistically significant decrease (P \< 0.05) in the anxiety symptoms.

  [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

• Change in the symptoms of depression

  The Beck Depression Inventory is a self-report that provides a measure of the presence and severity of depression. Contains 21 items indicative of symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, suicidal thoughts or desires, pessimism, etc. Each item is answered on a 4-point scale, from 0 to 3, where each number is identified differently for each item, in all of them 0 means absence and 3 full presence (e.g. sadness), except for items 16 (changes in the sleep pattern) and 18 (changes in appetite) that contain 7 categories. The minimum and maximum scores in the test are 0 and 63. Cut-off points ha that allow classifying those evaluated in one of the following four groups: 0-13, minimum depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. It is expected a statistically significant decrease (P \< 0.05) in the depression symptoms.

  [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

• Change in the symptoms of General Anxiety Disorder

  On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively. It is expected a statistically significant decrease (P \< 0.05) in the General Anxiety symptoms.

  [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

• Change in the score of Posttraumatic stress symptoms

  The Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence It is a brief scale with 24 symptoms corresponding to the diagnosis of PTSD, to respond by self-report, and a scale was used discretely from 1 (strongly disagree) to 4 (strongly agree). The total score was obtained by arithmetic sum. The minimum possible is 24 and the maximum 96. It is expected a statistically significant decrease (P \< 0.05) in the posttraumatic stress symptoms.

  [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

• Changes in the Widespread fear Scale

  It is composed of seven items with options of 0 = nothing, 3 = a lot, and measures the fear in its emotional component, that is, the fear to adversities in the context and the feelings it disseminates, as well as others economic and social fears, in this case, adapted for the Sars-Cov2 pandemic. In previous studies, an acceptable internal consistency of .95 was reached. It consists of several items about the fear of being a SARS Cov2 victim in diverse contexts. In the present study, a Cronbach alpha coefficient of 0.96 was obtained. It is expected a statistically significant decrease (P \< 0.05) in the widespread fear symptoms.

  [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

• Change in the score of The Pittsburgh Sleep Quality Index.

  This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistically significant increase (P \< 0.05) in the Sleep Quality Index.

  [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Secondary Outcomes (1)

• Change on the Suicidal Thoughts Scale

  [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Study Arms (2)

Positive Psychology Intervention with chat

EXPERIMENTAL

Participants in this group will receive from 15 sessions of a Positive Psychology focused on the increase of wellbeing and sleep quality and decrease of anxiety and depression with the support of a chat service provided by therapists.

Behavioral: Online Intervention Mental Health COVID-19

Positive Psychology Intervention without chat

ACTIVE COMPARATOR

Participants in this group will receive from 15 sessions of a Positive Psychology focused on the increase of wellbeing and sleep quality and decrease of anxiety and depression without the support of the chat service.

Behavioral: Online Intervention Mental Health COVID-19

Interventions

Online Intervention Mental Health COVID-19 BEHAVIORAL

The Online Intervention Mental Health COVID-19 aims to provide to the target population a self-applied intervention based primarily on Positive Psychology, aimed at the recognition and development of strengths and virtues from the well-being approach. In addition, it is supported by elements of Cognitive Behavioral Therapy such as the components of emotion and the Antecedent-Response-Consequence (ARC) model of emotions. Elements of Behavioral Activation Therapy are also included, such as the importance of physical exercise and the relationship between physical anxiety and its effects on anxiety and depression. The intervention is made up of 15 modules that are adapted to the symptoms that the population may suffer from the global contingency caused by the COVID-19 pandemic. In addition to the Positive Psychology modules, a module with psychoeducation on grief and loss was added.

Positive Psychology Intervention with chat; Positive Psychology Intervention without chat

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To have access to a communication device with access to the internet (computer, tablet, and mobile).
• To have a valid email address.
• To have basic digital skills in the use of an operational system and internet browsing.
• To understand Spanish since all the contents are in this language

You may not qualify if:

• To have a diagnosis of psychotic disorder.
• To be receiving psychological and / or pharmacological treatment during the study

Sponsors & Collaborators

• Universidad Internacional de Valencia: lead
• Universidad Nacional Autonoma de Mexico: collaborator
• Universidad Autonoma de Ciudad Juarez: collaborator

Study Sites (1)

Universidad Autónoma de Ciudad Juárez

Juárez, Chihuahua, Mexico

Location

Related Publications (11)

• Davies EB, Morriss R, Glazebrook C. Computer-delivered and web-based interventions to improve depression, anxiety, and psychological well-being of university students: a systematic review and meta-analysis. J Med Internet Res. 2014 May 16;16(5):e130. doi: 10.2196/jmir.3142.

  PMID: 24836465 BACKGROUND

• Chávez-Valdez SM, Esparza-Del Villar OA, Ríos Velasco-Moreno L. Validation of a Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence. Journal of Aggression, Maltreatment & Trauma [Internet]. Informa UK Limited; 2020 Jan 8;1-13. DOI: http://dx.doi.org/10.1080/10926771.2019.1710635

  BACKGROUND

• Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.

  PMID: 32155789 BACKGROUND

• Beck AT, Steer, RA, Brown, GK. Manual for Beck Depression Inventory-II. (1996) San Antonio, TX: Psychological Corporation.

  BACKGROUND

• Beck AT, Steer RA, Ranieri WF. Scale for Suicide Ideation: psychometric properties of a self-report version. J Clin Psychol. 1988 Jul;44(4):499-505. doi: 10.1002/1097-4679(198807)44:43.0.co;2-6.

  PMID: 3170753 RESULT

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 RESULT

• Hishinuma ES, Miyamoto RH, Nishimura ST, Nahulu LB, Andrade NN, Makini GK Jr, Yuen NY, Johnson RC, Kim SP, Goebert DA, Guerrero AP. Psychometric properties of the state-trait anxiety inventory for Asian/Pacific-islander adolescents. Assessment. 2000 Mar;7(1):17-36. doi: 10.1177/107319110000700102.

  PMID: 10668003 RESULT

• Walsh S, Szymczynska P, Taylor SJC, Priebe S. The acceptability of an online intervention using positive psychology for depression: A qualitative study. Internet Interv. 2018 Jul 8;13:60-66. doi: 10.1016/j.invent.2018.07.003. eCollection 2018 Sep.

  PMID: 30206520 RESULT

• Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.

  PMID: 18388841 RESULT

• Dominguez-Rodriguez A, Sanz-Gomez S, Gonzalez Ramirez LP, Herdoiza-Arroyo PE, Trevino Garcia LE, de la Rosa-Gomez A, Gonzalez-Cantero JO, Macias-Aguinaga V, Arenas Landgrave P, Chavez-Valdez SM. Evaluation and Future Challenges in a Self-Guided Web-Based Intervention With and Without Chat Support for Depression and Anxiety Symptoms During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Form Res. 2024 Sep 30;8:e53767. doi: 10.2196/53767.

  PMID: 39348893 DERIVED

• Dominguez-Rodriguez A, De La Rosa-Gomez A, Hernandez Jimenez MJ, Arenas-Landgrave P, Martinez-Luna SC, Alvarez Silva J, Garcia Hernandez JE, Arzola-Sanchez C, Acosta Guzman V. A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 16;9(11):e23117. doi: 10.2196/23117.

  PMID: 33196449 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Parasomnias

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Anabel de la Rosa Gómez, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Paulina Arenas Landgrave, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Jasshel Teresa Salinas-Saldivar, MD

  Universidad Autónoma de Ciudad Juárez

  STUDY CHAIR

• Flor Rocio Ramirez-Martinez, PhD

  Universidad Autónoma de Ciudad Juárez

  STUDY CHAIR

• Sofía Cristina Martínez Luna, MD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients are not aware that there is an intervention group and a comparison group, the participants are not related and do not know each other. The conditions of the study are only known by the researcher, the therapists, and the Ethics Committee of ELPAC-UU Universidad de Ciencias del Comportamiento
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: External professor

Model Details: The study has two arms, one is the intervention group that receives the treatment in addition to a chat service and the other is the comparison group that will receive treatment without the chat service. The patients in both groups will be evaluated pre and post/treatment. The participants are assigned randomly to the intervention or comparison group.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 13, 2020
• Study Start: May 20, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: This data will be available approximately in december 2020 and it will be permanently available. It will be shared in the databases of the journal where the article(s) will be published
• Access Criteria: Through the servers of the journal(s) where we will publish the articles.

Locations

ME (1)