Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446407
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2007-03-09
Brief Title:
Evaluating the Benefits and Affordability of a Program to Improve the Care of Common Mental Disorders in Primary Care
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
The Effectiveness and Cost-effectiveness of a Collaborative Stepped Care Intervention for the Treatment of Common Mental Disorders in Primary Care Settings in Goa India
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANAS
Brief Summary:
Depressive and anxiety disorders termed as Common Mental Disorders affect as many as one in four persons attending primary care most patients do not receive effective treatments Although the integration of mental health in primary care is accepted as the only feasible way of managing Common Mental Disorders in developing countries there is no evidence demonstrating how this can be done in a manner which is effective and affordable The hypothesis of this trial is that a Collaborative Stepped Care package will be both clinically and cost-effective for the treatment of Common Mental Disorders in primary care
Detailed Description:
The goal of the research is to evaluate the clinical and cost-effectiveness of a Collaborative Stepped Care intervention for the treatment of Common Mental Disorders CMD in primary care in Goa India
The Collaborative Stepped Care intervention will be compared with Enhanced Usual care in a cluster randomized controlled trial in 24 primary care facilities the first phase of the trial will be located in 12 government run Primary Health Centres while the second phase will be located in 12 private family physiciangeneral practice facilities Approximately 2400 participants who screen positive on a screening questionnaire for CMD will be recruited from the 24 facilities a harmonic mean of 100 per cluster per arm of whom 23 will be ICD10 cases confirmed by a diagnostic interview the Revised Clinical Interview Schedule Follow-up interviews at home will be conducted by an independent team at 2 6 and 12 months post recruitment Allowing for 25 attrition during follow-up gives 650 patients in each arm with a confirmed CMD or a total of 960 in each arm contributing to analyses of the primary outcomes see below
The Collaborative Stepped Care intervention is a complex intervention comprising the following components screening for detection of cases psycho-education antidepressants inter-personal therapy yoga specialist supervision adherence management The method of delivery will be based on the stepped-care model which provides treatments according to the patients needs and incorporates strategies to overcome challenges to the integration of mental health in primary care in developing countries This will be compared with Enhanced Usual Care which will comprise screening for detection of cases provision of the diagnosis to the doctor and making antidepressants available in the facility-all these components will be available in the Collaborative Stepped care facilities as well The intervention will be delivered by two new full-time primary care human resources-the Health Assistant in both arms who will screen adult attenders and in the Collaborative Stepped Care arms the Health Counselor-who has been trained over 3 months and a part-time Psychiatrist supporting the primary care team
The primary analyses will be intention-to-treat regardless of adherence to the intervention and will be based on outcomes measured at 6 months All analyses will take into account any within-facility clustering resulting from the cluster randomized design and will include adjustment for any of the a-priori defined confounding factors for which randomization did not achieve balance between the two arms at baseline
The primary research question being answered and the analysis outputs are
Does the Collaborative Stepped Care Intervention have an effect on the outcome of Definite Cases Prevalence of CMD in the two arms amongst participants who had an International Classification of Diseases tenth edition ICD10 CMD at baseline
Does the Collaborative Stepped Care Intervention have an effect on the burden of CMD amongst patients who are Possible Cases Prevalence of CMD in the two arms in all screen-positive participants
Does the Collaborative Stepped Care Intervention have an effect on the outcome of Depression Cases Prevalence of CMD in the two arms amongst participants who had an ICD10 Depression at baseline
Does the Collaborative Stepped Care Intervention have an effect on the incidence of ICD10 CMD amongst Sub-threshold Cases Prevalence of CMD in the two arms in screen-positive participants who did not have an ICD10 CMD diagnosis at baseline
Secondary analyses will include
Comparison of prevalences listed above at 2 months as a measure of speed of recovery and at 12 months sustainability of effectiveness
Repeated measures analysis of CMD prevalence at 2 6 and 12 months to assess effect of the intervention over the whole 12 month follow-up period
Comparisons of Revised Clinical Interview Schedule CISR and General Health Questionnaire GHQ scores and World Health Organisation Disability Assessment Schedule WHO-DAS scores as continuous outcomes i at each endpoint and ii using repeated measures analyses combining information from the three endpoints
Interaction of gender education and co-morbidity with intervention effects
Interaction of facility type privatepublic with intervention effects
Interaction of baseline illness attribution somaticpsychosocial with intervention effects
Interaction of baseline severity of CISR scores with intervention effects
Comparison of adverse events between the two arms at 2 6 and 12 months
Per-protocol analysis
Adherence with minimum intervention at least one meeting with the Health Counselor in the Collaborative Stepped Care arm
Adherence with optimal intervention-completion of intervention-ie discharge by the Health Counselor or minimum therapeutic dose of either antidepressant 90 adherence over 90 days or Interpersonal Psychotherapy IPT 6 sessions over 4 months
Dose response relationship with levels of adherence
For the economic analysis health care costs and other patient- or family-borne costs will be computed and compared at 2 6 and 12 months and subsequently related to changes in health outcome both the primary outcome measure of depression status and also Quality Adjusted Life Years QALYs In the event that dominance is not shown ie the intervention is more effective but the costs are also more than the usual care group incremental cost-effectiveness ratios will be computed together with their confidence intervals using bootstrapping techniques to overcome expected skewness of cost data Cost-effectiveness acceptability curves will also be derived in order to show the probability of any cost-effective advantages for the component interventions at a range of willingness to pay threshold levels
We will also carry out a nested qualitative evaluation with the objective is to assess the participants perceptions of the quality of the care they received their satisfaction with this care the reasons why they diddid not take full advantage of the intervention offered and the impact of their health problems on their daily lives economic productivity and lives of family members We will also explore their experience of being a trial participant in particular the experience of the informed consent procedure reasons for participation their understanding of randomization Two in-depth interviews will be conducted with at least 96 participants the first about 1 month after enrolment and the second interview about 6 months later A second group of in-depth interviews will be carried out with members of the intervention team about the process of the intervention its successes and limitations on quality of care on the PHCs overall function and how future programs may address these We aim to interview at least one doctor from each facility and one Health Counselor from each PHC ie total of 24 Two in-depth interviews will be conducted with each staff member the first about 2 months after the initiation of the program The second interview will be conducted between 6 and 12 month after the initiation of the trial
The Collaborative Stepped Care intervention will be compared with Enhanced Usual care in a cluster randomized controlled trial in 24 primary care facilities the first phase of the trial will be located in 12 government run Primary Health Centres while the second phase will be located in 12 private family physiciangeneral practice facilities Approximately 2400 participants who screen positive on a screening questionnaire for CMD will be recruited from the 24 facilities a harmonic mean of 100 per cluster per arm of whom 23 will be ICD10 cases confirmed by a diagnostic interview the Revised Clinical Interview Schedule Follow-up interviews at home will be conducted by an independent team at 2 6 and 12 months post recruitment Allowing for 25 attrition during follow-up gives 650 patients in each arm with a confirmed CMD or a total of 960 in each arm contributing to analyses of the primary outcomes see below
The Collaborative Stepped Care intervention is a complex intervention comprising the following components screening for detection of cases psycho-education antidepressants inter-personal therapy yoga specialist supervision adherence management The method of delivery will be based on the stepped-care model which provides treatments according to the patients needs and incorporates strategies to overcome challenges to the integration of mental health in primary care in developing countries This will be compared with Enhanced Usual Care which will comprise screening for detection of cases provision of the diagnosis to the doctor and making antidepressants available in the facility-all these components will be available in the Collaborative Stepped care facilities as well The intervention will be delivered by two new full-time primary care human resources-the Health Assistant in both arms who will screen adult attenders and in the Collaborative Stepped Care arms the Health Counselor-who has been trained over 3 months and a part-time Psychiatrist supporting the primary care team
The primary analyses will be intention-to-treat regardless of adherence to the intervention and will be based on outcomes measured at 6 months All analyses will take into account any within-facility clustering resulting from the cluster randomized design and will include adjustment for any of the a-priori defined confounding factors for which randomization did not achieve balance between the two arms at baseline
The primary research question being answered and the analysis outputs are
Does the Collaborative Stepped Care Intervention have an effect on the outcome of Definite Cases Prevalence of CMD in the two arms amongst participants who had an International Classification of Diseases tenth edition ICD10 CMD at baseline
Does the Collaborative Stepped Care Intervention have an effect on the burden of CMD amongst patients who are Possible Cases Prevalence of CMD in the two arms in all screen-positive participants
Does the Collaborative Stepped Care Intervention have an effect on the outcome of Depression Cases Prevalence of CMD in the two arms amongst participants who had an ICD10 Depression at baseline
Does the Collaborative Stepped Care Intervention have an effect on the incidence of ICD10 CMD amongst Sub-threshold Cases Prevalence of CMD in the two arms in screen-positive participants who did not have an ICD10 CMD diagnosis at baseline
Secondary analyses will include
Comparison of prevalences listed above at 2 months as a measure of speed of recovery and at 12 months sustainability of effectiveness
Repeated measures analysis of CMD prevalence at 2 6 and 12 months to assess effect of the intervention over the whole 12 month follow-up period
Comparisons of Revised Clinical Interview Schedule CISR and General Health Questionnaire GHQ scores and World Health Organisation Disability Assessment Schedule WHO-DAS scores as continuous outcomes i at each endpoint and ii using repeated measures analyses combining information from the three endpoints
Interaction of gender education and co-morbidity with intervention effects
Interaction of facility type privatepublic with intervention effects
Interaction of baseline illness attribution somaticpsychosocial with intervention effects
Interaction of baseline severity of CISR scores with intervention effects
Comparison of adverse events between the two arms at 2 6 and 12 months
Per-protocol analysis
Adherence with minimum intervention at least one meeting with the Health Counselor in the Collaborative Stepped Care arm
Adherence with optimal intervention-completion of intervention-ie discharge by the Health Counselor or minimum therapeutic dose of either antidepressant 90 adherence over 90 days or Interpersonal Psychotherapy IPT 6 sessions over 4 months
Dose response relationship with levels of adherence
For the economic analysis health care costs and other patient- or family-borne costs will be computed and compared at 2 6 and 12 months and subsequently related to changes in health outcome both the primary outcome measure of depression status and also Quality Adjusted Life Years QALYs In the event that dominance is not shown ie the intervention is more effective but the costs are also more than the usual care group incremental cost-effectiveness ratios will be computed together with their confidence intervals using bootstrapping techniques to overcome expected skewness of cost data Cost-effectiveness acceptability curves will also be derived in order to show the probability of any cost-effective advantages for the component interventions at a range of willingness to pay threshold levels
We will also carry out a nested qualitative evaluation with the objective is to assess the participants perceptions of the quality of the care they received their satisfaction with this care the reasons why they diddid not take full advantage of the intervention offered and the impact of their health problems on their daily lives economic productivity and lives of family members We will also explore their experience of being a trial participant in particular the experience of the informed consent procedure reasons for participation their understanding of randomization Two in-depth interviews will be conducted with at least 96 participants the first about 1 month after enrolment and the second interview about 6 months later A second group of in-depth interviews will be carried out with members of the intervention team about the process of the intervention its successes and limitations on quality of care on the PHCs overall function and how future programs may address these We aim to interview at least one doctor from each facility and one Health Counselor from each PHC ie total of 24 Two in-depth interviews will be conducted with each staff member the first about 2 months after the initiation of the program The second interview will be conducted between 6 and 12 month after the initiation of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None