Clinical trial NCT06230237: Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program to Address Depression
Official title: Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program for the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Internet Based Intervention
Psychological Intervention
Professional Support
Mental Health
Self-guided
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Hospital Francesc de Borja
First posted: 2024-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Background: Depression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, guided support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence. Objective: The current study 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. Methods: The proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 100 patient participants, with a loss-to-follow-up rate of 30%. Discussion: A study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Treatment efficacy
timeFrame: Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).
Secondary outcomes:
measure: Quality of life related to health
timeFrame: Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).
Other outcomes:
measure: Adherence to the treatment
timeFrame: Immediately after the intervention
measure: Implementation outcome: Feasibility
timeFrame: Immediately after the intervention
measure: Implementation outcome: Acceptability
timeFrame: Immediately after the intervention
measure: Implementation outcome: Appropiateness
timeFrame: Immediately after the intervention
measure: Implementation outcome: Normalization
timeFrame: Immediately after the intervention
measure: Implementation outcome: Attitudes Towards Psychological Online Intervention
timeFrame: Immediately after the intervention
measure: Implementation outcome: Sustainability
timeFrame: Immediately after the intervention
measure: Implementation outcome: Satisfactions
timeFrame: Immediately after the intervention
Locations:
city: Tavernes de la Valldigna
country: Spain
facility: Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
state: Valencia
Study officials:
affiliation: Universidad Jaume I
name: Azucena García Palacios
role: STUDY_CHAIR
affiliation: F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
name: Pedro Vera Albero
role: STUDY_DIRECTOR
affiliation: F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
name: Raquel Escriva Sanchis
role: STUDY_CHAIR
affiliation: F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
name: Clara Bretó García
role: STUDY_CHAIR
References:
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