NCT06230237

Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program to Address Depression

Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program for the Treatment of Depression

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universitat Jaume I · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Smiling is fun + professional support	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.
BEHAVIORAL	Smiling is fun	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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-06-01
• Completion: 2024-12-30
• First posted: 2024-01-30
• Last updated: 2024-01-30

Locations

1 site across 1 country: Spain