Clinical trial NCT03062215: Efficacy of a Culturally Adapted Cognitive Behavioural Internet-delivered Treatment for Depression
Official title: Assessing the Efficacy of a Culturally Adapted Cognitive Behavioural Internet-delivered Treatment for Depression: Protocol for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Culturally adapted psychotherapy
Internet-delivered treatment
Depression
Latin America
Lead sponsor: Silver Cloud Health
Sponsor class: OTHER
Collaborators: name: Irish Research Council
First posted: 2017-02-23
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire -9
timeFrame: 6 months
Secondary outcomes:
measure: Generalised Anxiety Disorder 7
timeFrame: 6 months
Other outcomes:
measure: Satisfaction with Treatment Questionnaire
timeFrame: 2 months
measure: Helpful Aspects of Therapy Questionnaire
timeFrame: weekly for 7 weeks
Locations:
city: Bogota
country: Colombia
facility: University Los Andes
city: Bucaramanga
country: Colombia
facility: University of Bucaramanga
Study officials:
affiliation: University of Dublin, Trinity College
name: Derek Richards, PhD
role: STUDY_DIRECTOR
affiliation: University of Dublin, Trinity College
name: Alicia Salamanca, MSc
role: PRINCIPAL_INVESTIGATOR
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