Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04740879
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2021-02-01
Brief Title:
The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
The Effects of the Be Mindful Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression
Status:
COMPLETED
Status Verified Date:
2023-05
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:
None
Brief Summary:
This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy Be Mindful Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression Participants will either receive the intervention at the start of the study or four months after the start of the study ie at 3-month follow-up which will allow research staff to assess if reductions in depression are due to the intervention or something else Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention and will investigate possible reasons for the change in depression ie why the intervention produces change
Detailed Description:
Participant outcome variables will be assessed weekly for the first month after baseline This will include the primary dependent variable ie depressive symptoms but will also include variables that will be explored as potential mechanisms of change ie mindfulness decentering rumination worry self-compassion and dysfunctional attitudes The final weekly assessment will represent the Post-Intervention assessment
Brief follow-up assessments of the primary dependent variable will be given 1-month and 2-months after the final weekly questionnaire There will be a 3-month assessment that measures potential mechanisms of change in addition to the primary dependent variable
After the 3-month follow-up the Waitlist Control condition will be given access to the intervention All participants ie in both conditions will be asked to complete another month of weekly questionnaires These questionnaires will be identical to the first set of weekly questionnaires and will allow mechanisms of change to be evaluated in the Waitlist Control condition
Brief follow-up assessments of the primary dependent variable will be given 1-month and 2-months after the final weekly questionnaire There will be a 3-month assessment that measures potential mechanisms of change in addition to the primary dependent variable
After the 3-month follow-up the Waitlist Control condition will be given access to the intervention All participants ie in both conditions will be asked to complete another month of weekly questionnaires These questionnaires will be identical to the first set of weekly questionnaires and will allow mechanisms of change to be evaluated in the Waitlist Control condition
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 |
|---|---|---|---|
| SU-20-01 | OTHER_GRANT | State University of New York at Buffalo | None |