Efficacy of a Culturally Adapted Cognitive Behavioural Internet-delivered Treatment for Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Space from Depression

• Registration Number: NCT03062215
• Lead Sponsor: Silver Cloud Health

Brief Summary

The study seeks to evaluate the efficacy of a culturally adapted internet-delivered treatment for depression in Colombia. The research involves two studies: (a) the cultural adaptation of the Space from Depression cognitive-behavioural internet-delivered programme, and (b) the implementation of the culturally adapted intervention using a randomised controlled trial methodology. The study will be a first contribution of a culturally adapted low-intensity internet-delivered intervention with Latin Americans.

Detailed Description

Depression is the principal cause of disability in the world. High rates of prevalence of depression in general populations and college students have been found worldwide and in various cultural groups. For instance, a 12-month prevalence rate has been estimated in the U.S. at 9.5% and in Europe at 8.5% of the population. In Colombia, 12-month prevalence is between 6.2% and 12.1%. The Colombian National Mental Health Survey has estimated point prevalence of mild to moderate depressive symptoms at 15.6% and severe depressive symptoms at 4.2% of adults. On the other hand, there are significant barriers for accessing mental health services in Colombia. About 50% of the population does not have access to health services, while the majority of the population with mental health problems do not have adequate mental health insurance coverage.

Although low-intensity interventions for depression have been developed in western high-income countries and these interventions therefore have been influenced by their specific cultural context (for example, Ireland, UK, Australia), it is important to consider how cultural context may impact on the adaptation for use in LMICs such as Colombia. The authors argue that cultural aspects need to be taken into consideration when translating and adapting interventions to help guarantee similar results to what have been achieved in high-income countries.

General method Aims and Hypothesis: We aim to assess the efficacy of a culturally adapted cognitive behavioural internet-delivered treatment for college students with depressive symptoms in Colombia. In line with other studies in high-income countries (HICs), and using an already established intervention, we hypothesise that the culturally adapted Space from Depression programme will be efficacious, with significant changes within the treatment group and differences post-treatment between the active treatment and the waiting list control group.

The study is a mixed method approach utilising in study 1, quantitative and qualitative methods to assist in the cultural adaptation of the Space from Depression intervention and in study 2 a randomised control design to examine the efficacy of the culturally-adapted intervention.

Procedure The programme Space from Depression will be culturally adapted for a Colombian population using cultural sensitivity and ecological validity frameworks, including principles from cross-cultural assessment research. (Study 1). Once the programme is culturally adapted, it will be tested using a randomised controlled trial methodology (Study 2).

Study Timeline

• Study Start: 2016-08-02
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Primary Completion: 2018-03-01
• Study Completion: 2018-06-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• 18 years old and above
• Mild to moderately severe depressive symptoms: (PHQ-9 score 10-19)

Exclusion Criteria

• Severe depressive symptoms >19 on PHQ-9
• Suicidal ideation or intent: Score of 2 or above on PHQ-9 question 9
• Psychosis
• Currently in psychological treatment for depression
• On medication for less than 1 month
• Alcohol or drugs misuse
• Previous diagnosis of an organic mental health disorder
• Depression preceding or coinciding a diagnosed medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Space from depression	Space from Depression	SilverCloud Health is a leading provider of online therapeutic solutions to support and promote positive behavior change and mental wellness. SilverCloud delivers interventions depression. The treatment includes self-monitoring, behavioural activation, cognitive restructuring, and challenging core beliefs. All modules have the same structure and format, which consist of quizzes, videos, educational content, activities with homework suggestions and a module review page. Also, users have a supporter, who will give feedback asynchronously (D Richards et al., 2015). Research on the SilverCloud interventions has yielded significant clinical outcomes (D Richards et al., 2015).

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire -9	6 months	depression symptoms

Secondary Outcome Measures

Name	Time	Method
Generalised Anxiety Disorder 7	6 months	anxiety symptoms

Trial Locations

Locations (2)

University Los Andes; 🇨🇴 Bogota, Colombia

University of Bucaramanga; 🇨🇴 Bucaramanga, Colombia