Depression
Conditions
Keywords
Depression, Internet Based Intervention, Psychological Intervention, Professional Support, Mental Health, Self-guided
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.
Interventions
BEHAVIORALSmiling 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.
BEHAVIORALSmiling 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.
Sponsors
Hospital Francesc de Borja
Universitat Jaume I
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy | Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months). | Change of depression symtpmatology through the Beck Depression Inventory (BDI-II). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life related to health | Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months). | The qualitiy of life related to health apsects will be measured using : EuroQol (EQ-5D) and Short Form Health Survey (SF-12) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implementation outcome: Acceptability | Immediately after the intervention | Professionals' assessment: Acceptability of Intervention Measure (AIM) (Weiner et al., 2017). A 4-item scale (from 1= completely disagree to 5= completely agree) that assesses the perception of the stakeholders about the agreeableness of treatment in a specific context. The construct has shown good psychometric properties with high levels of internal consistency (α =0.89) and test-retest reliability (α =0.83). |
| Implementation outcome: Appropiateness | Immediately after the intervention | Professionals' assessment: Intervention Appropriateness Measure (IAM) (Weiner et al., 2017). A 4-item scale (from 1= completely disagree to 5= completely agree) that measures the appropriateness of the intervention. The scale has shown good psychometric properties with high levels of internal consistency (α =0.87) and test-retest reliability (α =0.87) |
| Implementation outcome: Normalization | Immediately after the intervention | Professionals' assessment: Normalization MeAsure Development Questionnaire (NoMAD) (Finch et al., 2018). Based on the Normalization Process Theory, the NoMAD, a questionnaire of 13 items 5-Likert scale (from strongly agree to strongly disagree), has been developed to assess the process of normalization (May et al., 2009). The NoMAD focuses on four dimensions: coherence, cognitive participation, collective action, and reflexive monitoring. This questionnaire has demonstrated high levels of internal consistency along the four dimensions (20 items) (alpha=0.89). |
| Adherence to the treatment | Immediately after the intervention | The adherence to the treatment will be assessed according to the moduls done by the patient in the plataform |
| Implementation outcome: Sustainability | Immediately after the intervention | Professionals' assessment: Barriers and facilitators of the implementation (FBI). The FBI is a questionnaire specifically developed for this study and the study conducted by Lorente-Català et al. (2022). The questionnaire was created following the systematic review on EBT implementation barriers and facilitators among third sector organizations (Bach-Mortensen et al., 2018). As a result, 28 items assess the possible barriers, and 15 items evaluate the facilitators. |
| Implementation outcome: Satisfactions | Immediately after the intervention | Client Satisfaction Questionnaire adapted to Internet-Based Interventions (CSQ-I; Boß et al., 2016). This 9-item questionnaire assesses participants' satisfaction with IBI. Items are presented on a 1 to 4 Likert scale in which 1 does not apply to me and 4 does apply to me. The total score ranges from 8 to 32. It has adequate psychometric properties, Boß et al. (2016) rate Omega = 0.93 and 0.95 in two different samples. |
| Implementation outcome: Attitudes Towards Psychological Online Intervention | Immediately after the intervention | Professionals' assessment: Attitudes towards Psychological Online Interventions (APOI) (Schröder et al., 2015). A 16-item questionnaire, with a 5-point Likert scale, assesses attitudes toward IBT. The APOI explores four dimensions; Skepticism and Perception of Risks, Confidence in Effectiveness, Technologization Threat and Anonymity Benefits. The scale has shown acceptable to good internal consistency (α=0.77) (Schröder et al., 2015). |
| Implementation outcome: Feasibility | Immediately after the intervention | Professionals' assessment: Feasibility of Intervention Measure (FIM) (Weiner et al., 2017). A four items scale on a 5-point Likert scale assess the feasibility of an intervention in a specific context. The FIM showed high levels of internal consistency (α =0,89) and test-retest reliability coefficients (α =0,88). |
Countries
Spain
Contacts
Primary ContactRosa Lorente Català
Outcome results
None listed