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Internet-based Depression Treatment: Differential Efficacy of Different Therapeutic Components

NCT ID: NCT03159715

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2021-11-30

Brief Summary

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The objective of the present project is to study the differential effectiveness of three brief self-applied via the Internet interventions for mild to moderate depression: a global protocol composed of several therapeutic components (psychoeducation, cognitive restructuring, behavioral activation, positive psychology, and relapse prevention), a protocol just based on behavioral activation (BA), and a protocol just based on positive psychology (PP). The purpose is to know the specific contribution of each therapeutic components in the treatment of depression.

Detailed Description

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Depression is one of the most important health problems worldwide, which generates important costs, both from the economic point of view as from the social and personal one. If not properly treated, it may become chronic and therefore interferes significantly in all areas of operation. Hence, one of the most important challenges within this scope is the design of new ways to apply treatments in a way that maximizes its therapeutic efficiency. Information and Communication Technologies (ICTs) have proven their utility as they are very useful in order to provide help to all those in need. It is a field of study very novel which will become more important in the short term. Several internationally renowned research groups have launched self-applied treatment programs through the Internet in order to address this issue. Results obtained so far are consistent and promising, and show these treatments as effective. However, these treatments have different therapeutic components and it is important to identify the specific contribution of each of them. Therefore, the objective of the present project is to study the differential effectiveness of three brief self-applied via the Internet interventions for mild to moderate depression: a global protocol composed of several therapeutic components (psychoeducation, cognitive restructuring, behavioral activation, positive psychology, and relapse prevention), a protocol just based on behavioral activation (BA), and a protocol just based on positive psychology (PP). A minimum of 192 participants diagnosed with mild to moderate depression symptoms will be randomly assigned to one of the three experimental conditions: an Internet-based global protocol composed of several therapeutic components (n=64); a Internet-based protocol based on BA (n=64), and an Internet-based program based on PP (n=64). Our hypothesis is that it is possible to progress and improve in the treatment of depression through intervention strategies applied through the Internet.

Conditions

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Depression

Keywords

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Internet, Behavioral Activation, Positive Psychology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Internet-based Global Protocol

Intervention group that carries out the Internet-based Global Protocol and receives therapist support.

Group Type EXPERIMENTAL

Internet-based Global Protocol

Intervention Type BEHAVIORAL

Internet-based Global Protocol is an Internet-based treatment which includes therapeutic components of evidence-based treatments for depression: Motivation, Psychoeducation, Cognitive Therapy, and Relapse Prevention. Furthermore, it incorporates a Behavioural Activation component (BA). The whole protocol stresses the importance and benefits of being active and remaining involved in life, values and goals. The program also includes a component of Positive Psychology (PP). It allows the individual to learn and practice adaptive ways to cope with depressive and anxiety symptoms and confront daily problems. It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.

Internet-based Behavioral Activation Protocol

Intervention group that carries out the Internet-based Behavioral Activation Protocol and receives therapist support.

Group Type EXPERIMENTAL

Internet-based Behavioral Activation Protocol

Intervention Type BEHAVIORAL

Internet-based Behavioral Activation Protocol is an Internet-based treatment based on Behavioral Activation. It stresses the importance and benefits of being active and remaining involved in life, values and goals . It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.

IInternet-based Positive Psychology Protocol

Intervention group that carries out the Internet-based Positive Psychology Protocol and receives therapist support.

Group Type EXPERIMENTAL

Internet-based Positive Psychology Protocol

Intervention Type BEHAVIORAL

Internet-based Positive Psychology Protocol is an Internet-based treatment based on Positive Psychology, offering strategies to promote and enhance positive mood. It is an Internet-based treatment based on Positive Psychology. It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.

Interventions

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Internet-based Global Protocol

Internet-based Global Protocol is an Internet-based treatment which includes therapeutic components of evidence-based treatments for depression: Motivation, Psychoeducation, Cognitive Therapy, and Relapse Prevention. Furthermore, it incorporates a Behavioural Activation component (BA). The whole protocol stresses the importance and benefits of being active and remaining involved in life, values and goals. The program also includes a component of Positive Psychology (PP). It allows the individual to learn and practice adaptive ways to cope with depressive and anxiety symptoms and confront daily problems. It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.

Intervention Type BEHAVIORAL

Internet-based Behavioral Activation Protocol

Internet-based Behavioral Activation Protocol is an Internet-based treatment based on Behavioral Activation. It stresses the importance and benefits of being active and remaining involved in life, values and goals . It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.

Intervention Type BEHAVIORAL

Internet-based Positive Psychology Protocol

Internet-based Positive Psychology Protocol is an Internet-based treatment based on Positive Psychology, offering strategies to promote and enhance positive mood. It is an Internet-based treatment based on Positive Psychology. It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18-65 years old.
* Having mild to moderate depression symptoms.
* Providing written, informed consent.
* Being able to understand and read Spanish.
* Having daily access to the Internet in their natural environment.

Exclusion Criteria

* Being diagnosed a severe mental disorder (people with the following mental disorders will be excluded from the study: schizophrenia, bipolar disorder and personality disorders from clusters A and B).
* Being diagnosed an alcohol and/or substance dependence disorder.
* The presence of high suicidal risk.
* A medical disease or condition which prevent the participant from carry out the psychological treatment.
* Receiving another psychological treatment while the study is still ongoing.
* The increase and/or changes in the medication of participants receiving pharmacological treatment during the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role collaborator

Universitat Jaume I

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adriana Mira, Phd

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Cristina Botella, Professor

Role: STUDY_DIRECTOR

Universitat Jaume I

Locations

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University Jaume I

Castellon, Castellón, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Adriana Mira, PhD

Role: CONTACT

Phone: +34964387651

Email: [email protected]

Cristina Botella, Professor

Role: CONTACT

Phone: +34964387639

Email: [email protected]

Facility Contacts

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Cristina Botella, Psychology

Role: primary

Adriana Mira, Psychology

Role: backup

References

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Mira A, Breton-Lopez J, Garcia-Palacios A, Quero S, Banos RM, Botella C. An Internet-based program for depressive symptoms using human and automated support: a randomized controlled trial. Neuropsychiatr Dis Treat. 2017 Mar 31;13:987-1006. doi: 10.2147/NDT.S130994. eCollection 2017.

Reference Type BACKGROUND
PMID: 28408833 (View on PubMed)

Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJ, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. JAMA Psychiatry. 2017 Apr 1;74(4):351-359. doi: 10.1001/jamapsychiatry.2017.0044.

Reference Type BACKGROUND
PMID: 28241179 (View on PubMed)

Botella C, Mira A, Moragrega I, Garcia-Palacios A, Breton-Lopez J, Castilla D, Riera Lopez Del Amo A, Soler C, Molinari G, Quero S, Guillen-Botella V, Miralles I, Nebot S, Serrano B, Majoe D, Alcaniz M, Banos RM. An Internet-based program for depression using activity and physiological sensors: efficacy, expectations, satisfaction, and ease of use. Neuropsychiatr Dis Treat. 2016 Feb 23;12:393-406. doi: 10.2147/NDT.S93315. eCollection 2016.

Reference Type BACKGROUND
PMID: 27042067 (View on PubMed)

Karyotaki E, Kleiboer A, Smit F, Turner DT, Pastor AM, Andersson G, Berger T, Botella C, Breton JM, Carlbring P, Christensen H, de Graaf E, Griffiths K, Donker T, Farrer L, Huibers MJ, Lenndin J, Mackinnon A, Meyer B, Moritz S, Riper H, Spek V, Vernmark K, Cuijpers P. Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis. Psychol Med. 2015 Oct;45(13):2717-26. doi: 10.1017/S0033291715000665. Epub 2015 Apr 17.

Reference Type BACKGROUND
PMID: 25881626 (View on PubMed)

Mira A, Diaz-Garcia A, Castilla D, Campos D, Romero S, Breton-Lopez J, Garcia-Palacios A, Banos R, Botella C. Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies. BMC Psychiatry. 2019 May 3;19(1):133. doi: 10.1186/s12888-019-2099-2.

Reference Type DERIVED
PMID: 31053067 (View on PubMed)

Related Links

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http://www.labpsitec.uji.es

Description Laboratory of Psychology and Technology of the University Jaume I

http://psicologiaytecnologia.com

Description Web site of the intervention programs

Other Identifiers

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5

Identifier Type: -

Identifier Source: org_study_id