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

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ClinicalTrials.gov Identifier: NCT03062215
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Irish Research Council
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Space from Depression Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Efficacy of a Culturally Adapted Cognitive Behavioural Internet-delivered Treatment for Depression: Protocol for a Randomised Controlled Trial
Actual Study Start Date : August 2, 2016
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Yo puedo sentirme bien

No Intervention: Control Group
Waiting list



Primary Outcome Measures :
  1. Patient Health Questionnaire -9 [ Time Frame: 6 months ]
    depression symptoms


Secondary Outcome Measures :
  1. Generalised Anxiety Disorder 7 [ Time Frame: 6 months ]
    anxiety symptoms


Other Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062215


Locations
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Colombia
University Los Andes
Bogota, Colombia
University of Bucaramanga
Bucaramanga, Colombia
Sponsors and Collaborators
Silver Cloud Health
Irish Research Council
Investigators
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Study Director: Derek Richards, PhD Trinity College Dublin
Principal Investigator: Alicia Salamanca, MSc Trinity College Dublin

Publications:
Bernal, Sáez-Santiago E. Culturally centered psychosocial interventions. Journal of Community Psychology. 2006;34(2):121.
Richards D, Timulak L, Hevey D. A comparison of two online cognitive-behavioural interventions for symptoms of depression in a student population: The role of therapist responsiveness. Counselling & Psychotherapy Research. 2013;13(3):184-93.
Ministry of Health. National Mental Health survey. Bogota, Colombia: Ministry of Health; 2015. Report No.: 978-958-8903-19-4.
Rodriguez J. La atención de Salud Mental en América Latina y el caribe. Rev Psiquiatr Urug. 2007;71(2):117-24.
Elliott R, Slatick E, Urman M. Qualitative change process research on psychotherapy: Alternative strategies. Psychological Test and Assessment Modeling. 2001;43(3):69.
Richards D, Timulak L. Satisfaction with therapist-delivered vs. self-administered online cognitive behavioural treatments for depression symptoms in college students. British Journal of Guidance & Counselling. 2013;41(2):193-207.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Silver Cloud Health
ClinicalTrials.gov Identifier: NCT03062215     History of Changes
Other Study ID Numbers: CAiCBT
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silver Cloud Health:
Culturally adapted psychotherapy
Internet-delivered treatment
Depression
Latin America
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders