Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054061
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-09-05
Brief Title:
Evaluation the Efficacy Think and Cope Positively Program
Sponsor:
Universidad Pontificia Comillas
Organization:
Universidad Pontificia Comillas
Study Overview
Official Title:
Improving Subjective Wellbeing Despite a Severe Psychiatric Condition Through Think and Cope Positively Program A Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
PA
Brief Summary:
The purpose of this study is to determine whether an integrated protocol based on cognitive behavioural therapy positive psychology and third generation therapies is effective in improve the subjective well-being of people affected by a severe mental illness SMI
The design of the study is a cluster randomized control trial with two arms Experimental groups will receive 15 sessions to enhance positive emotions optimism adaptive coping finding a purpose in life and sharing it with people who are important to the user The control group will remain on a waitlist with their treatment as usual TAU After the control period 15 weeks participants of the experimental groups have the chance to receive the intervention Both groups will be measure before and after de 15 intervention weeks Additionally follow-up measures of the experimental group will be taken after 3 and 6 months
The design of the study is a cluster randomized control trial with two arms Experimental groups will receive 15 sessions to enhance positive emotions optimism adaptive coping finding a purpose in life and sharing it with people who are important to the user The control group will remain on a waitlist with their treatment as usual TAU After the control period 15 weeks participants of the experimental groups have the chance to receive the intervention Both groups will be measure before and after de 15 intervention weeks Additionally follow-up measures of the experimental group will be taken after 3 and 6 months
Detailed Description:
This research aims to generate evidence on the usefulness of interventions focused on the well-being of people diagnosed with SMI trying to alleviate some of the limitations found in previous protocols
Regarding the content of the sessions optimism low levels of depression social support and the degree of agreement with the therapist have recently been identified as the factors that best predict subjective well-being in people affected by SMI Therefore modules on optimism and coping focused on well-being will be included maintaining the emphasis of the work on positive emotions By adding an individual work session in which goals and objectives are agreed upon by the therapist and user the consensus will be strengthened between both parties After discussing the construction of a life project throughout the protocol the process the process will conclude with a session combined users and the special persons chosen by the participants Both members will have the opportunity to share with each other
Finally we will follow the indications of recent studies which demonstrate that in order to improve the optimistic response in psychiatric populations it is necessary to reformulate negative thinking practice hopeful thinking practice gratitude and build a life project
Regarding the content of the sessions optimism low levels of depression social support and the degree of agreement with the therapist have recently been identified as the factors that best predict subjective well-being in people affected by SMI Therefore modules on optimism and coping focused on well-being will be included maintaining the emphasis of the work on positive emotions By adding an individual work session in which goals and objectives are agreed upon by the therapist and user the consensus will be strengthened between both parties After discussing the construction of a life project throughout the protocol the process the process will conclude with a session combined users and the special persons chosen by the participants Both members will have the opportunity to share with each other
Finally we will follow the indications of recent studies which demonstrate that in order to improve the optimistic response in psychiatric populations it is necessary to reformulate negative thinking practice hopeful thinking practice gratitude and build a life project
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CX22-00110 | OTHER_GRANT | Fundación la Caixa | None |