Skip to main content
OpenTrials
Completed

NCT Number: NCT03062215

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Los Andes, Bogotá, Colombia

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Space from Depression

Behavioral

Space from Depression programme (Yo puedo sentirme Bien -Spanish version) consists of seven modules of cognitive-behavioural therapy. 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.

Other names: Yo puedo sentirme bien

Primary outcomes

  1. Patient Health Questionnaire -9

    Time frame: 6 months

    depression symptoms

Secondary outcomes

  1. Generalised Anxiety Disorder 7

    Time frame: 6 months

    anxiety symptoms

Other outcomes

  1. Satisfaction with Treatment Questionnaire

    Time frame: 2 months

    Patient satisfaction

  2. Helpful Aspects of Therapy Questionnaire

    Time frame: weekly for 7 weeks

    Significant events

Sponsors and collaborators

Lead sponsor

Silver Cloud Health

Other

Collaborators

  • Irish Research Council

Registry information

Official study title

Assessing the Efficacy of a Culturally Adapted Cognitive Behavioural Internet-delivered Treatment for Depression: Protocol for a Randomised Controlled Trial

Acronym: CAiCBT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.