Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864353
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-21
Brief Title:
Internet-delivered Intervention Targeting Residual Cognitive Symptoms After Major Depressive Disorder
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
A Guided Internet-delivered Intervention for Adults With Residual Cognitive Symptoms After Major Depressive Disorder Study Protocol for a Randomized Controlled Trial Investigating Clinical Effects
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
RestDep
Brief Summary:
Background Cognitive impairment and difficulties are frequently observed in individuals suffering from major depressive disorder These impairments and difficulties can persist into remission as residual cognitive symptoms Consequently affecting daily life functioning and quality of life for those affected Few scalable interventions have targeted these symptoms and measured long-term clinical effects such as depression relapse
Detailed Description:
BackgroundCognitive impairment and difficulties are frequently observed in individuals suffering from major depressive disorder These impairments and difficulties can persist into remission as residual cognitive symptoms Consequently affecting daily life functioning and quality of life for those affected Few scalable interventions have targeted these symptoms and measured long-term clinical effects such as depression relapse
Objectives The aim is to assess the clinical effects of an intervention targeting residual cognitive symptoms after major depressive disorder More specifically if residual cognitive symptoms would be significantly decreased from pre- to post-treatment and remain stable at the 6-month and 2 year follow-up
Methods the study is a randomized waitlist controlled trial including a total of 60 participants 30 in each arm Primary measures are residual cognitive symptoms measured by the Behavioral Rating Inventory of Executive Functions Adults BRIEF-A and Perceived Deficit Questionnaire 5 PDQ-5 Secondary outcome measures are Depression measured by Montgomery Aasberg Depression Rating Scale and Patient Health Questionnaire 9 and 2 PHQ-9 and PHQ2 Satisfaction with life measured by Satisfaction with life scale SWLS Credibility measured by the Treatment Credibility and Expectation Scale Rumination measured by the Rumination Response Scale RRS Depression screening assessed using the MINI International Psychiatric Interview Usage data measured by number of log-ins session length and days in treatment Quantitative statistical methods will be used to analyze data
Discussion The results from the study will contribute to field of internet interventions and provide former depressed adults with an easy access intervention in the treatment of residual cognitive symptoms
Objectives The aim is to assess the clinical effects of an intervention targeting residual cognitive symptoms after major depressive disorder More specifically if residual cognitive symptoms would be significantly decreased from pre- to post-treatment and remain stable at the 6-month and 2 year follow-up
Methods the study is a randomized waitlist controlled trial including a total of 60 participants 30 in each arm Primary measures are residual cognitive symptoms measured by the Behavioral Rating Inventory of Executive Functions Adults BRIEF-A and Perceived Deficit Questionnaire 5 PDQ-5 Secondary outcome measures are Depression measured by Montgomery Aasberg Depression Rating Scale and Patient Health Questionnaire 9 and 2 PHQ-9 and PHQ2 Satisfaction with life measured by Satisfaction with life scale SWLS Credibility measured by the Treatment Credibility and Expectation Scale Rumination measured by the Rumination Response Scale RRS Depression screening assessed using the MINI International Psychiatric Interview Usage data measured by number of log-ins session length and days in treatment Quantitative statistical methods will be used to analyze data
Discussion The results from the study will contribute to field of internet interventions and provide former depressed adults with an easy access intervention in the treatment of residual cognitive symptoms
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