Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04117464
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2019-09-30
Brief Title:
Contextual Therapies and Cognitive Behavioral Therapy as Transdiagnostic Group Interventions for Emotional Disorders
Sponsor:
University of Oviedo
Organization:
University of Oviedo
Study Overview
Official Title:
Efficacy of Contextual Therapies Behavioral Activation and Acceptance and Commitment Therapy and Cognitive Behavioral Therapy CBT in Group Format as a Transdiagnostic Intervention in Emotional Disorders
Status:
COMPLETED
Status Verified Date:
2022-05
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:
TRANSACTIVA
Brief Summary:
This study aims to investigate the efficacy of three psychotherapeutic programs in group format Acceptance and Commitment Therapy ACT Behavioral Activation AC and Transdiagnostic Cognitive Behavioral Therapy TD-CBT for the treatment of emotional disorders Considering the data of the literature and the results of previous research it is expected that this clinical investigation shows that transdiagnostic interventions that are tested AC ACT TD-CBT cause clinical changes in the post-treatment However it is expected that in post-treatment and in the short and medium-term follow-up significant differences will be found between the transdiagnostic therapies examined in all outcome criteria variables and that the greatest effectiveness and effectiveness be achieved in contextual therapies in particular in Behavioral Activation therapy It is expected that the study design will allow obtaining firm evidence of the active therapeutic ingredients from the analysis of the differential efficacy of each of the psychotherapeutic programs As a final consequence and based on the results and discussion on transdiagnostic conditions and transtherapeutic elements it is expected to develop a unified treatment protocol in group format -as an efficient work format and appropriate to the needs of public health services- to be easily applied in the field of primary care It could facilitate access to effective treatment of common mental disorders in public health services
Detailed Description:
This study aims to investigate the efficacy of three psychotherapeutic programs in group format Acceptance and Commitment Therapy ACT Behavioral Activation AC and Transdiagnostic Cognitive Behavioral Therapy TD-CBT for the treatment of emotional disorders Considering the data of the literature and the results of previous research it is expected that this clinical investigation shows that transdiagnostic interventions that are tested AC ACT TD-CBT cause clinical changes in the post-treatment However it is expected that in post-treatment and in the short and medium term follow-up significant differences will be found between the transdiagnostic therapies examined in all outcome criteria variables and that the greatest effectiveness and effectiveness be achieved in contextual therapies in particular in Behavioral Activation therapy It is expected that the study design will allow obtaining firm evidence of the active therapeutic ingredients from the analysis of the differential efficacy of each of the psychotherapeutic programs As a final consequence and based on the results and discussion on transdiagnostic conditions and transtherapeutic elements it is expected to develop a unified treatment protocol in group format -as an efficient work format and appropriate to the needs of public health services- to be easily applied in the field of primary care It could facilitate access to effective treatment of common mental disorders in public health services
The present investigation has as general objectives
1 Establish the effectiveness effectiveness and efficiency of Behavioral Activation AC Acceptance and Commitment ACT and Transdiagnostic Cognitive-Behavioral TD-CBT therapy applied in group format for the treatment of emotional disorders in the context of Primary Care
2 Analyze the differential utility and adequacy of contextual transdiagnostic therapy AC ACT and cognitive behavioral therapy TD-CBT according to clinical conditions of the disorder characteristics of the subjects and of the therapeutic procedure and the transdiagnostic assumptions that define them
3 Develop a unified treatment protocol for emotional disorders for implementation in primary care
Specific objectives are
1 Identify patterns of psychological inflexibility experiential avoidance activation and cognitive fusion and cognitive biases in people with emotional disorders anxiety and or depression
2 To assess the efficacy effectiveness and efficiency of three transdiagnostic therapies AC ACT and TD-CBT applied in group format for the treatment of emotional disorders analyzing the evolution of the outcome criteria defined in relation to emotional state and functionality of the patients assigned to each experimental treatment condition and in relation to a waiting list condition
3 Assess the adequacy and specificity of AC ACT and TD-CBT in the treatment of emotional disorders according to different conditions patients clinical state characteristics of the context and the therapeutic procedure defined as outcome criteria variables
4 Identify the active therapeutic ingredients of the therapies on the results of the efficacy effectiveness and adequacy of the interventions
5 Develop a Unified Treatment Protocol to facilitate the implementation of an efficacious and effective intervention of emotional disorders in public health institutions especially in the context of Primary Care
6 Maintain a website to disseminate information to general population regarding services provided in the context of this research project and to share experiences with other professionals and researchers
The sample will be composed by patients who obtain a score that indicates clinically significant symptoms according to the Hospital Anxiety and Depression Scale HADS Zigmond and Snaith 1983 All participants have to sign the informed consent after being informed about the objectives and procedure of the study
Participants that meet inclusion criteria will be randomly assigned to the experimental and control conditions The programs will be developed in group format maximum 8 patients group and will be implemented consecutively until reaching the required sample size
Preselected patients will be interviewed by one of the researchers The investigator explains the objectives and procedures and then participants sign the informed consent document and answer the Hospital Anxiety and Depression Scale HADS Zigmond and Snaith 1983 When the result indicates clinically significant symptoms participants will be randomly assigned according to the table of numbers to one of the different conditions of the investigation three experimental ACT AC TD-TCC and a control WL Next participants will be cited for an individual evaluation session in which the study variables will be explored through clinical interview and scales After the individual evaluation session experimental groups will receive 8 group psychotherapy sessions specific to each condition Then each patient have follow ups at 3 6 9 and 12 months after finishing the therapeutic group
Wait List group will be evaluated after the same period of time of the experimental groups and with the same procedure Subsequently participants will be offered the possibility of receiving the intervention that has been shown to be most effective and or suitable according to their peculiarities
Therapy was administered by two licensed clinical psychologists In order to ensure adhesion of clinical psychologists to therapeutic protocols the intervention sessions were audio-recorded and weekly supervision sessions by the principal investigator of study were held In addition regular peer-to-peer coaching and supervision meetings were held to ensure protocol adherence
Analysis of data
The descriptive study of the sample and a study of the equivalence of control and experimental groups with the relevant statistics according to the type of variable will be carried out
The investigators will study patients evolution and compare experimental and control groups in all variables using inferential statistics and evaluate the clinical change at experimental groups For the statistical analysis a database and the statistical program IBM SPSS will be used
The present investigation has as general objectives
1 Establish the effectiveness effectiveness and efficiency of Behavioral Activation AC Acceptance and Commitment ACT and Transdiagnostic Cognitive-Behavioral TD-CBT therapy applied in group format for the treatment of emotional disorders in the context of Primary Care
2 Analyze the differential utility and adequacy of contextual transdiagnostic therapy AC ACT and cognitive behavioral therapy TD-CBT according to clinical conditions of the disorder characteristics of the subjects and of the therapeutic procedure and the transdiagnostic assumptions that define them
3 Develop a unified treatment protocol for emotional disorders for implementation in primary care
Specific objectives are
1 Identify patterns of psychological inflexibility experiential avoidance activation and cognitive fusion and cognitive biases in people with emotional disorders anxiety and or depression
2 To assess the efficacy effectiveness and efficiency of three transdiagnostic therapies AC ACT and TD-CBT applied in group format for the treatment of emotional disorders analyzing the evolution of the outcome criteria defined in relation to emotional state and functionality of the patients assigned to each experimental treatment condition and in relation to a waiting list condition
3 Assess the adequacy and specificity of AC ACT and TD-CBT in the treatment of emotional disorders according to different conditions patients clinical state characteristics of the context and the therapeutic procedure defined as outcome criteria variables
4 Identify the active therapeutic ingredients of the therapies on the results of the efficacy effectiveness and adequacy of the interventions
5 Develop a Unified Treatment Protocol to facilitate the implementation of an efficacious and effective intervention of emotional disorders in public health institutions especially in the context of Primary Care
6 Maintain a website to disseminate information to general population regarding services provided in the context of this research project and to share experiences with other professionals and researchers
The sample will be composed by patients who obtain a score that indicates clinically significant symptoms according to the Hospital Anxiety and Depression Scale HADS Zigmond and Snaith 1983 All participants have to sign the informed consent after being informed about the objectives and procedure of the study
Participants that meet inclusion criteria will be randomly assigned to the experimental and control conditions The programs will be developed in group format maximum 8 patients group and will be implemented consecutively until reaching the required sample size
Preselected patients will be interviewed by one of the researchers The investigator explains the objectives and procedures and then participants sign the informed consent document and answer the Hospital Anxiety and Depression Scale HADS Zigmond and Snaith 1983 When the result indicates clinically significant symptoms participants will be randomly assigned according to the table of numbers to one of the different conditions of the investigation three experimental ACT AC TD-TCC and a control WL Next participants will be cited for an individual evaluation session in which the study variables will be explored through clinical interview and scales After the individual evaluation session experimental groups will receive 8 group psychotherapy sessions specific to each condition Then each patient have follow ups at 3 6 9 and 12 months after finishing the therapeutic group
Wait List group will be evaluated after the same period of time of the experimental groups and with the same procedure Subsequently participants will be offered the possibility of receiving the intervention that has been shown to be most effective and or suitable according to their peculiarities
Therapy was administered by two licensed clinical psychologists In order to ensure adhesion of clinical psychologists to therapeutic protocols the intervention sessions were audio-recorded and weekly supervision sessions by the principal investigator of study were held In addition regular peer-to-peer coaching and supervision meetings were held to ensure protocol adherence
Analysis of data
The descriptive study of the sample and a study of the equivalence of control and experimental groups with the relevant statistics according to the type of variable will be carried out
The investigators will study patients evolution and compare experimental and control groups in all variables using inferential statistics and evaluate the clinical change at experimental groups For the statistical analysis a database and the statistical program IBM SPSS will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None