NCT03159715

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

4.5 years

First QC Date

May 17, 2017

Last Update Submit

November 23, 2020

Conditions

Depression

Keywords

Internet, Behavioral Activation, Positive Psychology

Outcome Measures

Primary Outcomes (1)

  • Change in the Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) at pre, post intervention and at 3 and 12 months follow-ups.

    The BDI-II is one of the most widely used questionnaires to evaluate the severity of depression in pharmacological and psychotherapy trials. It consists of 21 items about the different symptoms characterizing the major depression disorder, summed to obtain the total score, which can be a maximum of 63 points. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and a test-retest reliability of around 0.8.

    Up to 12 months

Secondary Outcomes (4)

  • The Positive and Negative Affect Schedule (PANAS) (Watson, Clark y Tellegen, 1988; Sandín et al., 1999) at pre, post intervention and at 3 and 12 months follow-ups.

    Up to 12 months

  • Overall Anxiety Severity and Impairment Scale (OASIS) Overall Depression Severity and Impairment Scale (ODSIS) at pre, post intervention and at 3 and 12 months follow-ups.

    Up to 12 months

  • Overall Depression Severity and Impairment Scale (ODSIS) at pre, post intervention and at 3 and 12 months follow-ups.

    Up to 12 months

  • Multicultural Quality of Life Index (MQLI) at pre, post intervention and at 3 and 12 months follow-ups.

    Up to 12 months

Study Arms (3)

Internet-based Global Protocol

EXPERIMENTAL

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

Behavioral: Internet-based Global Protocol

Internet-based Behavioral Activation Protocol

EXPERIMENTAL

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

Behavioral: Internet-based Behavioral Activation Protocol

IInternet-based Positive Psychology Protocol

EXPERIMENTAL

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

Behavioral: Internet-based Positive Psychology Protocol

Interventions

Internet-based Global ProtocolBEHAVIORAL

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 Global Protocol
Internet-based Behavioral Activation ProtocolBEHAVIORAL

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.

Internet-based Behavioral Activation Protocol
Internet-based Positive Psychology ProtocolBEHAVIORAL

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.

IInternet-based Positive Psychology Protocol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Jaume I

Castellon, Castellón, 12006, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 28408833BACKGROUND

  • 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.

    PMID: 28241179BACKGROUND

  • 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.

    PMID: 27042067BACKGROUND

  • 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.

    PMID: 25881626BACKGROUND

  • 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.

    PMID: 31053067DERIVED

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Adriana Mira, Phd

    Universitat Jaume I

    PRINCIPAL INVESTIGATOR

  • Cristina Botella, Professor

    Universitat Jaume I

    STUDY DIRECTOR

Central Study Contacts

Adriana Mira, PhD

CONTACT

+34964387651miraa@uji.es

Cristina Botella, Professor

CONTACT

+34964387639botella@uji.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

May 1, 2017

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)