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

Depression Clinical Trial

— CAiCBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062215
• Other study ID #: CAiCBT
• Status: Completed
• Phase: N/A
• Start date: August 2, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: September 2018
• Source: Silver Cloud Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Colombia	University Los Andes	Bogota
Colombia	University of Bucaramanga	Bucaramanga

Sponsors (2)

Lead Sponsor	Collaborator
Silver Cloud Health	Irish Research Council

Country where clinical trial is conducted

Colombia, 

References & Publications (18)

Ayuso-Mateos JL, Vázquez-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. — View Citation

Bernal, Sáez-Santiago E. Culturally centered psychosocial interventions. Journal of Community Psychology. 2006;34(2):121.

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, Lépine 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. — View Citation

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. — View Citation

Elliott R, Slatick E, Urman M. Qualitative change process research on psychotherapy: Alternative strategies. Psychological Test and Assessment Modeling. 2001;43(3):69.

García-Campayo J, Zamorano E, Ruiz MA, Pardo A, Pérez-Páramo M, López-Gómez 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. — View Citation

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. Epub 2007 Sep 14. — View Citation

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. Erratum in: Arch Gen Psychiatry. 2005 Jul;62(7):709. Merikangas, Kathleen R [added]. — View Citation

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. — View Citation

Llewelyn SP. Psychological therapy as viewed by clients and therapists. Br J Clin Psychol. 1988 Sep;27 ( Pt 3):223-37. — View Citation

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):309-16. doi: 10.1037/a0023883. — View Citation

Ministry of Health. National Mental Health survey. Bogota, Colombia: Ministry of Health; 2015. Report No.: 978-958-8903-19-4.

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.

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. — View Citation

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.

Rodriguez J. La atención de Salud Mental en América Latina y el caribe. Rev Psiquiatr Urug. 2007;71(2):117-24.

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with Treatment Questionnaire	Patient satisfaction	2 months
Other	Helpful Aspects of Therapy Questionnaire	Significant events	weekly for 7 weeks
Primary	Patient Health Questionnaire -9	depression symptoms	6 months
Secondary	Generalised Anxiety Disorder 7	anxiety symptoms	6 months