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

September 7, 2018 updated by: Silver Cloud Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
        • University Los Andes
      • Bucaramanga, Colombia
        • University of Bucaramanga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Waiting list
Experimental: 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).
Behavioral: Space from Depression
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire -9
Time Frame: 6 months
depression symptoms
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalised Anxiety Disorder 7
Time Frame: 6 months
anxiety symptoms
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Treatment Questionnaire
Time Frame: 2 months
Patient satisfaction
2 months
Helpful Aspects of Therapy Questionnaire
Time Frame: weekly for 7 weeks
Significant events
weekly for 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silver Cloud Health

Collaborators

Irish Research Council

Investigators

  • Study Director: Derek Richards, PhD, University of Dublin, Trinity College
  • Principal Investigator: Alicia Salamanca, MSc, University of Dublin, Trinity College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAiCBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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