Ignite Creation Date:
2024-05-06 @ 1:49 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01903096
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2013-07-02
Brief Title:
Treating Emotional Disorders in Primary Care With Psychological Techniques
Sponsor:
Psicofundación Fundación Española para Promoción Desarrollo Científico y Profesional de la Psicolo
Organization:
Psicofundación Fundación Española para Promoción Desarrollo Científico y Profesional de la Psicolo
Study Overview
Official Title:
A Pilot Study to Treat Emotional Disorders in Primary Care With Evidence-based Psychological Techniques A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-03
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:
PsychPC
Brief Summary:
The strong demand for primary care PC services in Spain exceeds resources Part of this demand is due to the increasing number of anxiety depression and somatization disorders that affect the general population These disorders commonly known as emotional disorders are very common in Spanish PC settings they are poorly detected by physicians rarely receive adequate treatment if they receive treatment it is mostly drugs instead of psychological treatment they generate a highly frequent use of PC services a greater burden than physical diseases and tend to become chronic without treatment
Other countries have successfully put psychological techniques in PC into practice in the United Kingdom the program known as Improving Access to Psychological Therapies has obtained very positive results in order to correctly diagnose and treat emotional disorders The results obtained in terms of symptoms quality of life diagnosis etc have been better than the usual treatment offered in PC services involving no side effects fewer relapses and lower costs in the long term
The general aim of this study is to test how well a psychological treatment program for anxiety depression and somatization disorders works in PC and to compare the results obtained after seven 90-minute group sessions every to two to four weeks approximately for a period of 24 weeks with the usual treatment offered in Spanish PC services Similar results to the ones already obtained in other countries are expected to be found
Approximately 1130 adults regardless of their age and sex with an anxiety depression andor somatization disorder diagnosed with a simple and short questionnaire will participate in this study
Participation will be voluntary and confidentiality will be guaranteed Half of the participants in the study will be randomly assigned to receive their usual care and the other half will receive psychological treatment within the same health care centre Since it is a double-blind study neither the health professional nor the patient will know which treatment will be applied Psychological assessments will be carried out before and after receiving treatment and participants will be followed up at 3 6 and 12 months
Participation will pose no risks different from the typically present when receiving usual treatment The aim of this study will be to maximize benefits and reduce potential harms principle of proportionality
Other countries have successfully put psychological techniques in PC into practice in the United Kingdom the program known as Improving Access to Psychological Therapies has obtained very positive results in order to correctly diagnose and treat emotional disorders The results obtained in terms of symptoms quality of life diagnosis etc have been better than the usual treatment offered in PC services involving no side effects fewer relapses and lower costs in the long term
The general aim of this study is to test how well a psychological treatment program for anxiety depression and somatization disorders works in PC and to compare the results obtained after seven 90-minute group sessions every to two to four weeks approximately for a period of 24 weeks with the usual treatment offered in Spanish PC services Similar results to the ones already obtained in other countries are expected to be found
Approximately 1130 adults regardless of their age and sex with an anxiety depression andor somatization disorder diagnosed with a simple and short questionnaire will participate in this study
Participation will be voluntary and confidentiality will be guaranteed Half of the participants in the study will be randomly assigned to receive their usual care and the other half will receive psychological treatment within the same health care centre Since it is a double-blind study neither the health professional nor the patient will know which treatment will be applied Psychological assessments will be carried out before and after receiving treatment and participants will be followed up at 3 6 and 12 months
Participation will pose no risks different from the typically present when receiving usual treatment The aim of this study will be to maximize benefits and reduce potential harms principle of proportionality
Detailed Description:
Secondary objectives
The experimental in comparison with the control group will report a greater decrease including pre-post-treatment differences and follow-up at 3 6 and 12 months in emotional symptoms total scores of anxiety depressive and somatic symptoms as measured by the Patient Health Questionnaire cognitive factors and percentage of cases with probable emotional disorders anxiety depression and somatization disorders
The experimental in comparison with the control group will report a decrease in its levels of work family and social impairment Sheehan Disability Scale and an increase in its levels of physical health psychological social and environmental quality of life as measured by the different World Health Organization Quality of Life WHOQOL-BREF scales
The experimental group in comparison with the control group will reduce the frequency of Primary Care visits as well as other health care costs at 6 month follow-up
In addition the experimental group will report higher treatment satisfaction than the control group
The following variables will be assessed
Clinical symptoms anxiety depression somatizations levels of adjustment work family social
Quality of life physical health psychological social environmental
Emotional symptoms and thoughts worries beliefs coping strategies negative thoughts etc
Treatment satisfaction
Frequent use of services
Psychoactive drug use
Patient recruitment
Inclusion criteria
Any adult patient seeking Primary Care treatment at any of the selected sites in Spain with a probable anxiety mood andor somatisation disorder diagnosed with the Patient Health Questionnaire PHQ-9 may voluntarily participate in the study regardless of hisher age and sex
Exclusion criteria
Patients with severe mental disorders eg bipolar disorder personality disorder
Patients with a history of frequent or recent suicide attempts
Patients with a high level of disability as measured by the Sheehan Disability Scale who seek Primary Care treatment
Patients with severe anxiety disorders eg comorbid substance use disorders and severe mood disorders Patient Health Questionnaire PHQ-9 total score 20
Patients who do not meet diagnostic criteria for a probable emotional disorder or do not reach the established Patient Health Questionnaire cut-off points
The minimum sample size required to obtain a significant result has been calculated with the Sample-Power SPSS program The study should include 563 patients in each condition with a total of 1126 patients accounting for a 20 attrition or dropout With this sample size the result will be statistically significant 85 statistical power when comparing both groups even if they differ by one point only with a standard deviation of 5 a range of scores from 0-27 for the PHQ-9 and it will enable us to conclude that the result is different for each group with a 95 confidence level
Both groups will be equivalent in all measures before receiving treatment 2x2 within and between-groups analyses of variance group x treatment will be conducted for each dependent variable The effect size for each dependent variable will be calculated in both groups as well as the 95 confidence interval taking into account the number of treatment sessions Primary analyses will follow the intention-to-treat principle in such a way that all individuals who participate in the study will be considered as members of one group even if they have not yet completed the protocol Therapeutic success will be obtained if the average scores of the experimental group are significantly lower than those of the control group in the dependent variables anxiety depression and somatization symptoms and when the effect sizes are medium to large and significantly higher than those of the control group especially in the case of anxiety symptoms In addition the results obtained by each group in terms of degree of disability work family and social quality of life treatment satisfaction costs and cost-efficiency of both treatments will be compared
It will be carried out in twenty five Primary Care PC centres in Madrid Valencia Albacete Mallorca Murcia Vizcaya Cordoba Galicia and Cantabria and may be extended to other centres and cities
It is expected to start in September 2013 and posttreatment will end by December 2018 The study will be open to participants until recruitment is completed The follow-up period will end by September 2019
Psicofundación Spanish Foundation for the Promotion Scientific and Professional Development of Psychology and the Spanish Ministry of Economy and Competitiveness are funding this three-year project
The main contact is Dr Antonio Cano-Vindel professor at the Faculty of Psychology of Complutense University of Madrid E-mail canovindelpsiucmes Telephone 34607705740
The experimental in comparison with the control group will report a greater decrease including pre-post-treatment differences and follow-up at 3 6 and 12 months in emotional symptoms total scores of anxiety depressive and somatic symptoms as measured by the Patient Health Questionnaire cognitive factors and percentage of cases with probable emotional disorders anxiety depression and somatization disorders
The experimental in comparison with the control group will report a decrease in its levels of work family and social impairment Sheehan Disability Scale and an increase in its levels of physical health psychological social and environmental quality of life as measured by the different World Health Organization Quality of Life WHOQOL-BREF scales
The experimental group in comparison with the control group will reduce the frequency of Primary Care visits as well as other health care costs at 6 month follow-up
In addition the experimental group will report higher treatment satisfaction than the control group
The following variables will be assessed
Clinical symptoms anxiety depression somatizations levels of adjustment work family social
Quality of life physical health psychological social environmental
Emotional symptoms and thoughts worries beliefs coping strategies negative thoughts etc
Treatment satisfaction
Frequent use of services
Psychoactive drug use
Patient recruitment
Inclusion criteria
Any adult patient seeking Primary Care treatment at any of the selected sites in Spain with a probable anxiety mood andor somatisation disorder diagnosed with the Patient Health Questionnaire PHQ-9 may voluntarily participate in the study regardless of hisher age and sex
Exclusion criteria
Patients with severe mental disorders eg bipolar disorder personality disorder
Patients with a history of frequent or recent suicide attempts
Patients with a high level of disability as measured by the Sheehan Disability Scale who seek Primary Care treatment
Patients with severe anxiety disorders eg comorbid substance use disorders and severe mood disorders Patient Health Questionnaire PHQ-9 total score 20
Patients who do not meet diagnostic criteria for a probable emotional disorder or do not reach the established Patient Health Questionnaire cut-off points
The minimum sample size required to obtain a significant result has been calculated with the Sample-Power SPSS program The study should include 563 patients in each condition with a total of 1126 patients accounting for a 20 attrition or dropout With this sample size the result will be statistically significant 85 statistical power when comparing both groups even if they differ by one point only with a standard deviation of 5 a range of scores from 0-27 for the PHQ-9 and it will enable us to conclude that the result is different for each group with a 95 confidence level
Both groups will be equivalent in all measures before receiving treatment 2x2 within and between-groups analyses of variance group x treatment will be conducted for each dependent variable The effect size for each dependent variable will be calculated in both groups as well as the 95 confidence interval taking into account the number of treatment sessions Primary analyses will follow the intention-to-treat principle in such a way that all individuals who participate in the study will be considered as members of one group even if they have not yet completed the protocol Therapeutic success will be obtained if the average scores of the experimental group are significantly lower than those of the control group in the dependent variables anxiety depression and somatization symptoms and when the effect sizes are medium to large and significantly higher than those of the control group especially in the case of anxiety symptoms In addition the results obtained by each group in terms of degree of disability work family and social quality of life treatment satisfaction costs and cost-efficiency of both treatments will be compared
It will be carried out in twenty five Primary Care PC centres in Madrid Valencia Albacete Mallorca Murcia Vizcaya Cordoba Galicia and Cantabria and may be extended to other centres and cities
It is expected to start in September 2013 and posttreatment will end by December 2018 The study will be open to participants until recruitment is completed The follow-up period will end by September 2019
Psicofundación Spanish Foundation for the Promotion Scientific and Professional Development of Psychology and the Spanish Ministry of Economy and Competitiveness are funding this three-year project
The main contact is Dr Antonio Cano-Vindel professor at the Faculty of Psychology of Complutense University of Madrid E-mail canovindelpsiucmes Telephone 34607705740
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-001955-11 | EUDRACT_NUMBER | None | None |