Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537869
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
iCBT for Seniors With Depression in Primary Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The New Internet Generation iCBT Treatment for Seniors With Mild-moderate Depression - a Pragmatic Randomised Controlled Trial in the Primary Care Context
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to evaluate the potential benefits of internet cognitive behavioural therapy iCBT for elderly patients with mildmoderate depression and compare its effectiveness with the current treatment as usual TAU at primary care centres PCCs
The specific aims are to study if
iCBT is as effective as TAU in reducing depressive symptoms iCBT is as effective as TAU in increasing quality of life iCBT is as effective as TAU in increasing the function in patients 65 years and older with mildmoderate depression attending primary care with the perspective of 36 months
Participants will
Work with the iCBT program 10-12 weeks or become TAU at their PCCs Followed-up at 3 6 12 24 and 36 months of their symptoms quality of life and function
The specific aims are to study if
iCBT is as effective as TAU in reducing depressive symptoms iCBT is as effective as TAU in increasing quality of life iCBT is as effective as TAU in increasing the function in patients 65 years and older with mildmoderate depression attending primary care with the perspective of 36 months
Participants will
Work with the iCBT program 10-12 weeks or become TAU at their PCCs Followed-up at 3 6 12 24 and 36 months of their symptoms quality of life and function
Detailed Description:
Study Objective
The primary aim is to determine if iCBT is as effective for treating mild-moderate depression in older adults 65 as it is for younger age groups The study will assess various outcomes throughout 3 6 12 24 and 36 months including depressive symptoms quality of life workability relationships activities of daily living and social participation
Trial Design
Its a randomised controlled trial RCT with two groups intervention iCBT and control TAU The pragmatic design closely resembles real-world primary care conditions to ensure the results apply to routine clinical practice
Population
Participants will be recruited from primary care centres PCCs in Sweden targeting individuals over 65 years diagnosed with mild to moderate depressive symptoms The study aims to include all eligible patients from participating PCCs ensuring a broad representation of the target population
Intervention and Control
Intervention
iCBT program with minimal therapist contact initiated promptly after inclusion and lasting 10-12 weeks Weekly therapistnurse contact via email or telephone is part of the intervention
Control
TAU according to Swedish National Guidelines may include guided self-help face-to-face CBT excluding iCBT andor antidepressants provided by GPs or nurses at the PCCs
Patient Selection and Randomization
Patients will be screened using standardised guidelines NICE guidelines for depression diagnosed via the MINI diagnostic interview Mini International Neuropsychiatric Interview and randomised centrally to avoid bias Due to the nature of the intervention blinding at the patient level isnt feasible but efforts will be made to blind researchers during data analysis
Follow-up and Data Collection
Multiple follow-up points up to 36 months will allow the researchers to assess the longer-term effects of iCBT compared to TAU Quantitative outcomes will be supplemented by qualitative data from focus group interviews with patients and staff exploring their experiences with iCBT
Focus Group Interviews
These will involve patients and staff separately aiming to gather insights into the acceptability feasibility and perceived effectiveness of iCBT in a primary care setting Qualitative analysis methods will be used to interpret and contextualise the findings from these interviews
The primary aim is to determine if iCBT is as effective for treating mild-moderate depression in older adults 65 as it is for younger age groups The study will assess various outcomes throughout 3 6 12 24 and 36 months including depressive symptoms quality of life workability relationships activities of daily living and social participation
Trial Design
Its a randomised controlled trial RCT with two groups intervention iCBT and control TAU The pragmatic design closely resembles real-world primary care conditions to ensure the results apply to routine clinical practice
Population
Participants will be recruited from primary care centres PCCs in Sweden targeting individuals over 65 years diagnosed with mild to moderate depressive symptoms The study aims to include all eligible patients from participating PCCs ensuring a broad representation of the target population
Intervention and Control
Intervention
iCBT program with minimal therapist contact initiated promptly after inclusion and lasting 10-12 weeks Weekly therapistnurse contact via email or telephone is part of the intervention
Control
TAU according to Swedish National Guidelines may include guided self-help face-to-face CBT excluding iCBT andor antidepressants provided by GPs or nurses at the PCCs
Patient Selection and Randomization
Patients will be screened using standardised guidelines NICE guidelines for depression diagnosed via the MINI diagnostic interview Mini International Neuropsychiatric Interview and randomised centrally to avoid bias Due to the nature of the intervention blinding at the patient level isnt feasible but efforts will be made to blind researchers during data analysis
Follow-up and Data Collection
Multiple follow-up points up to 36 months will allow the researchers to assess the longer-term effects of iCBT compared to TAU Quantitative outcomes will be supplemented by qualitative data from focus group interviews with patients and staff exploring their experiences with iCBT
Focus Group Interviews
These will involve patients and staff separately aiming to gather insights into the acceptability feasibility and perceived effectiveness of iCBT in a primary care setting Qualitative analysis methods will be used to interpret and contextualise the findings from these interviews
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None