NCT06230237

Brief Summary

Depression is a first level problem that poses a challenge for Primary Care (PC). The overload of care in this area requires lower-cost and more accessible alternatives. Internet-based self-applied cognitive behavioral treatments (CBCT) have demonstrated their efficacy and added advantages. The "Smiling is fun" program has been validated in Spanish PC and has demonstrated its usefulness and cost-effectiveness. Previous studies have shown that professional support or guidance increases the results of the TCCI. The aim of the present study is to contrast, by means of a randomized controlled trial, aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.

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
100

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2022

Typical duration 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

First Submitted

Initial submission to the registry

April 19, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

April 19, 2022

Last Update Submit

January 18, 2024

Conditions

Depression

Keywords

DepressionInternet Based InterventionPsychological InterventionProfessional SupportMental HealthSelf-guided

Outcome Measures

Primary Outcomes (1)

  • Treatment efficacy

    Change of depression symtpmatology through the Beck Depression Inventory (BDI-II).

    Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).

Secondary Outcomes (1)

  • Quality of life related to health

    Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).

Other Outcomes (8)

  • Adherence to the treatment

    Immediately after the intervention

  • Implementation outcome: Feasibility

    Immediately after the intervention

  • Implementation outcome: Acceptability

    Immediately after the intervention

  • +5 more other outcomes

Study Arms (2)

Professional support

ACTIVE COMPARATOR

Participants randomly assigned to this groups will receive the self-administered psychotherapy via the Internet a with telephone psychotherapeutic support.

Behavioral: Smiling is fun + professional support

Non professional support

ACTIVE COMPARATOR

Participants randomly assigned to this group will receive the self-administered psychotherapy via the Internet without telephone psychotherapeutic support.

Behavioral: Smiling is fun

Interventions

Smiling is fun + professional supportBEHAVIORAL

Participants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules. While they do the online program, they will receive periodically professional support. The professional support will be contacts of 20 minutes long, will take place every two weeks and will last 3 months.

Professional support
Smiling is funBEHAVIORAL

Participants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules.

Non professional support

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 65 years.
  • Ability to understand and read Spanish.
  • Meet diagnostic criteria for major depressive disorder (DSM-5).
  • Mild or moderate symptoms of the Spanish version of the Beck Depression Inventory-II (BDI-II) (14-19: mild depression; 20-28: moderate depression).
  • Episode duration of more than two weeks.
  • Have internet access at home and an email account.
  • The diagnosis of major depressive disorder will be confirmed by the standardized MINI International Neuropsychiatric Interview.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja

Tavernes de la Valldigna, Valencia, 46760, Spain

RECRUITING

Related Publications (7)

  • Mira A, Soler C, Alda M, Banos R, Castilla D, Castro A, Garcia-Campayo J, Garcia-Palacios A, Gili M, Hurtado M, Mayoral F, Montero-Marin J, Botella C. Exploring the Relationship Between the Acceptability of an Internet-Based Intervention for Depression in Primary Care and Clinical Outcomes: Secondary Analysis of a Randomized Controlled Trial. Front Psychiatry. 2019 May 10;10:325. doi: 10.3389/fpsyt.2019.00325. eCollection 2019.

    PMID: 31133899BACKGROUND

  • Romero-Sanchiz P, Nogueira-Arjona R, Garcia-Ruiz A, Luciano JV, Garcia Campayo J, Gili M, Botella C, Banos R, Castro A, Lopez-Del-Hoyo Y, Perez Ara MA, Modrego-Alarcon M, Mayoral Cleries F. Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multi-center, three-armed randomized controlled trial conducted in primary care. PLoS One. 2017 Feb 27;12(2):e0172741. doi: 10.1371/journal.pone.0172741. eCollection 2017.

    PMID: 28241025BACKGROUND

  • Montero-Marin J, Araya R, Perez-Yus MC, Mayoral F, Gili M, Botella C, Banos R, Castro A, Romero-Sanchiz P, Lopez-Del-Hoyo Y, Nogueira-Arjona R, Vives M, Riera A, Garcia-Campayo J. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial. J Med Internet Res. 2016 Aug 26;18(8):e231. doi: 10.2196/jmir.5695.

    PMID: 27565118BACKGROUND

  • Montero-Marin J, Prado-Abril J, Botella C, Mayoral-Cleries F, Banos R, Herrera-Mercadal P, Romero-Sanchiz P, Gili M, Castro A, Nogueira R, Garcia-Campayo J. Expectations among patients and health professionals regarding Web-based interventions for depression in primary care: a qualitative study. J Med Internet Res. 2015 Mar 10;17(3):e67. doi: 10.2196/jmir.3985.

    PMID: 25757358BACKGROUND

  • 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

  • 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

  • Lorente-Catala R, Font-Furnieles P, Escriva-Sanchis R, Berto-Garcia C, Vera-Albero P, Garcia-Palacios A. Telephone support vs. self-guidance in an Internet-based self-administered psychological program for the treatment of depression: Protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial. Internet Interv. 2024 Apr 20;36:100742. doi: 10.1016/j.invent.2024.100742. eCollection 2024 Jun.

    PMID: 38737981DERIVED

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Azucena García Palacios

    Universidad Jaume I

    STUDY CHAIR

  • Pedro Vera Albero

    F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja

    STUDY DIRECTOR

  • Raquel Escriva Sanchis

    F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja

    STUDY CHAIR

  • Clara Bretó García

    F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja

    STUDY CHAIR

Central Study Contacts

Rosa Lorente Català

CONTACT

691527941rlorente@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

April 19, 2022

First Posted

January 30, 2024

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

December 30, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

ES(1)