Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-06
Brief Title:
Group Cognitive Evolutionary Therapy for Depression
Sponsor:
University of Bucharest
Organization:
University of Bucharest
Study Overview
Official Title:
Group Cognitive Evolutionary Therapy for Depression - a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
GRCET
Brief Summary:
The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health especially on depressive symptoms and anxiety
Participants will be allocated in one of two conditions 1 Group Cognitive Evolutionary Therapy intervention or 2 Waitlist The intervention will consist of two 8-hour sessions of Group Cognitive Therapy in two consecutive days
The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention
Participants will be allocated in one of two conditions 1 Group Cognitive Evolutionary Therapy intervention or 2 Waitlist The intervention will consist of two 8-hour sessions of Group Cognitive Therapy in two consecutive days
The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention
Detailed Description:
The aim of the study is to assess the efficacy of Group Cognitive Evolutionary Therapy on depressive symptoms and other indicators of mental health for people with moderate depressive symptoms This clinical trial will provide essential insights into the potential benefits of this form of therapy The results will contribute to the development of a short economical and effective method of enhancing mental health for patients with moderate depressive symptoms
After recruitment participants will be randomly assigned to one of two conditions 1 Group Cognitive Evolutionary Therapy intervention or 2 Waitlist
The intervention group will participate in two 8-hour sessions of Cognitive Evolutionary Therapy over two consecutive days in groups of no less than 5 and no larger than 8 people These groups will be led by licensed psychologists with extensive knowledge of evolutionary psychology and cognitive evolutionary therapies
Both groups will be evaluated at 1 pre-intervention baseline 2 one week after the intervention 3 three months after the intervention and 4 six months after the intervention
GPower analysis yields a total of N 44 f 025 power 095 for the two conditions
The statistical analysis plan includes the analysis of primary and secondary outcomes which will be assessed using predefined measures described at the measures section Additionally the investigators will assess various predictors to gain insights into the factors influencing intervention outcomes These predictors will be measured using specific instruments including screeners Diagnostic and Statistical Manual Fifth Edition - Text Revision Self-Rated Level 1 Cross-Cutting Symptom Measure-adult version and The Personality Inventory for Diagnostic and Statistical Manual Fifth Edition-Brief Form-adult version and the Adverse Childhood Experiences questionnaire to assess adverse childhood experiences
Besides demographic assessors and the above mentioned instruments The Evolutionary Fitness Scale will be used both to determine predictors for the intervention outcome and as an assessment tool for the topics of interventions for each subject this being a central part of Cognitive Evolutionary Therapy
After recruitment participants will be randomly assigned to one of two conditions 1 Group Cognitive Evolutionary Therapy intervention or 2 Waitlist
The intervention group will participate in two 8-hour sessions of Cognitive Evolutionary Therapy over two consecutive days in groups of no less than 5 and no larger than 8 people These groups will be led by licensed psychologists with extensive knowledge of evolutionary psychology and cognitive evolutionary therapies
Both groups will be evaluated at 1 pre-intervention baseline 2 one week after the intervention 3 three months after the intervention and 4 six months after the intervention
GPower analysis yields a total of N 44 f 025 power 095 for the two conditions
The statistical analysis plan includes the analysis of primary and secondary outcomes which will be assessed using predefined measures described at the measures section Additionally the investigators will assess various predictors to gain insights into the factors influencing intervention outcomes These predictors will be measured using specific instruments including screeners Diagnostic and Statistical Manual Fifth Edition - Text Revision Self-Rated Level 1 Cross-Cutting Symptom Measure-adult version and The Personality Inventory for Diagnostic and Statistical Manual Fifth Edition-Brief Form-adult version and the Adverse Childhood Experiences questionnaire to assess adverse childhood experiences
Besides demographic assessors and the above mentioned instruments The Evolutionary Fitness Scale will be used both to determine predictors for the intervention outcome and as an assessment tool for the topics of interventions for each subject this being a central part of Cognitive Evolutionary Therapy
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