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CompletedNCT03062215CAiCBTUpdated Sep 10, 2018

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

An interventional study of Space from Depression in Depression, sponsored by Silver Cloud Health. Completed at 2 sites in Colombia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Silver Cloud Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2016, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Depression with a site in Colombia — 4 open to participants now, 5 under way, none of them phase 3. Depression · Colombia.

Enrollment
16th of 22
127 · median 230
Started
2016
the only one that year
No phase
14 of 24
2 open now
Registered
12th of 24
by date

Among the 24 studies in Depression with a site in Colombia, this one is the 16th largest by enrollment of the 22 interventional ones, is the only one that started in 2016, is one of 14 with no phase, and was the 12th registered.

By phase

24 studies; the count open now beside each. This study's row is marked.

No phasethis study14 · 2 open
Phase 37 · 0 open
Observational2 · 2 open
Phase 21 · 0 open

By the year they started

First in 1995; this study’s year is marked. 1 started in 2016.

Size and results

Median enrollment 230 across the 22 interventional studies, 2,512 across the 2 observational. Of the 17 that completed or were terminated, 10 (59%) have results posted.

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02

Study 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.

Read the 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).

03

Conditions studied

  • Depression

Browse trials for

Keywords

  • Culturally adapted psychotherapy
  • Internet-delivered treatment
  • Depression
  • Latin America
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • 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

  • No intervention
    Control Group

    Waiting list

Interventions

  • BehavioralSpace 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.

    Also known as: Yo puedo sentirme bien

06

What researchers measure

Primary outcomes

  1. Patient Health Questionnaire -9

    depression symptoms

    Time frame: 6 months

Secondary outcomes

  1. Generalised Anxiety Disorder 7

    anxiety symptoms

    Time frame: 6 months

Other outcomes

  1. Satisfaction with Treatment Questionnaire

    Patient satisfaction

    Time frame: 2 months

  2. Helpful Aspects of Therapy Questionnaire

    Significant events

    Time frame: weekly for 7 weeks

07

Study locations

2 sites
  • University Los Andes
    Bogota, Colombia
  • University of Bucaramanga
    Bucaramanga, Colombia
08

References and documents

Publications

  • Ayuso-Mateos JL, Vazquez-Barquero JL, Dowrick C, Lehtinen V, Dalgard OS, Casey P, Wilkinson C, Lasa L, Page H, Dunn G, Wilkinson G; ODIN Group. Depressive disorders in Europe: prevalence figures from the ODIN study. Br J Psychiatry. 2001 Oct;179:308-16. doi: 10.1192/bjp.179.4.308. PubMed 11581110 ↗
  • Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617. Erratum In: Arch Gen Psychiatry. 2005 Jul;62(7):709. Merikangas, Kathleen R [added]. PubMed 15939839 ↗
  • Bromet E, Andrade LH, Hwang I, Sampson NA, Alonso J, de Girolamo G, de Graaf R, Demyttenaere K, Hu C, Iwata N, Karam AN, Kaur J, Kostyuchenko S, Lepine JP, Levinson D, Matschinger H, Mora ME, Browne MO, Posada-Villa J, Viana MC, Williams DR, Kessler RC. Cross-national epidemiology of DSM-IV major depressive episode. BMC Med. 2011 Jul 26;9:90. doi: 10.1186/1741-7015-9-90. PubMed 21791035 ↗
  • Demyttenaere K, Bruffaerts R, Posada-Villa J, Gasquet I, Kovess V, Lepine JP, Angermeyer MC, Bernert S, de Girolamo G, Morosini P, Polidori G, Kikkawa T, Kawakami N, Ono Y, Takeshima T, Uda H, Karam EG, Fayyad JA, Karam AN, Mneimneh ZN, Medina-Mora ME, Borges G, Lara C, de Graaf R, Ormel J, Gureje O, Shen Y, Huang Y, Zhang M, Alonso J, Haro JM, Vilagut G, Bromet EJ, Gluzman S, Webb C, Kessler RC, Merikangas KR, Anthony JC, Von Korff MR, Wang PS, Brugha TS, Aguilar-Gaxiola S, Lee S, Heeringa S, Pennell BE, Zaslavsky AM, Ustun TB, Chatterji S; WHO World Mental Health Survey Consortium. Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization World Mental Health Surveys. JAMA. 2004 Jun 2;291(21):2581-90. doi: 10.1001/jama.291.21.2581. PubMed 15173149 ↗
  • 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.
  • Merz EL, Malcarne VL, Roesch SC, Riley N, Sadler GR. A multigroup confirmatory factor analysis of the Patient Health Questionnaire-9 among English- and Spanish-speaking Latinas. Cultur Divers Ethnic Minor Psychol. 2011 Jul;17(3):309-316. doi: 10.1037/a0023883. PubMed 21787063 ↗
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. PubMed 11556941 ↗
  • Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737. PubMed 10568646 ↗
  • Gilbody S, Richards D, Brealey S, Hewitt C. Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): a diagnostic meta-analysis. J Gen Intern Med. 2007 Nov;22(11):1596-602. doi: 10.1007/s11606-007-0333-y. Epub 2007 Sep 14. PubMed 17874169 ↗
  • Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21. PubMed 26523885 ↗
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PubMed 16717171 ↗
  • Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8. PubMed 20089179 ↗
  • Llewelyn SP. Psychological therapy as viewed by clients and therapists. Br J Clin Psychol. 1988 Sep;27(3):223-37. doi: 10.1111/j.2044-8260.1988.tb00779.x. PubMed 3191302 ↗
  • 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.
  • Salamanca-Sanabria A, Richards D, Timulak L, Connell S, Mojica Perilla M, Parra-Villa Y, Castro-Camacho L. A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial. JMIR Ment Health. 2020 Jan 31;7(1):e13392. doi: 10.2196/13392. PubMed 32003749 ↗
  • Salamanca-Sanabria A, Richards D, Timulak L, Castro-Camacho L, Mojica-Perilla M, Parra-Villa Y. Assessing the efficacy of a culturally adapted cognitive behavioural internet-delivered treatment for depression: protocol for a randomised controlled trial. BMC Psychiatry. 2018 Feb 27;18(1):53. doi: 10.1186/s12888-018-1634-x. PubMed 29482586 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2016 to primary completion in Mar 2018, 18 months.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 18 months is below that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2017
First posted
Feb 23, 2017
StartActual
Aug 2, 2016
Primary completionActual
Mar 1, 2018
CompletionActual
Jun 1, 2018
Last update
Sep 10, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03062215
Lead sponsor
Silver Cloud Health
Collaborators
Irish Research Council
Responsible party
Sponsor
First posted
Feb 23, 2017
Start date
Aug 2, 2016
Primary completion
Mar 1, 2018
Completion
Jun 1, 2018
Last update
Sep 10, 2018

Study contacts

Derek Richards, PhD
study director · University of Dublin, Trinity College
Alicia Salamanca, MSc
principal investigator · University of Dublin, Trinity College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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