Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04688567
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2020-12-17
Brief Title:
Patient-driven Internet Delivered Psychological Treatment
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Patient-driven Internet Delivered Psychological Treatment in a Primary Care Context a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-04
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:
The effect of iCBT for adults with anxiety disorders is well-known However drop-out rates are common In recent years more focus has been directed to the importance of patients being active agents in their own care and to increase the patients involvement in health care Studies show that involving patients in treatment decisions and management of their own health care can contribute to better treatment outcomes and more appropriate use of health care service
Few studies have evaluated patient involvement in iCBT-treatment This study aims to evaluate the effect of patient-driven iCBT-treatment for patients with anxiety disorders seeking primary care in a randomized controlled trial The study investigates the effect of patient-driven iCBT treatment of perceptions of being able to control the treatment and on drop-out from treatment In addition secondary research questions investigate measures of empowerment anxiety and depression symptoms general disability satisfaction with treatment and feelings of being able to cope with ones mental illness in patient-driven iCBT
Few studies have evaluated patient involvement in iCBT-treatment This study aims to evaluate the effect of patient-driven iCBT-treatment for patients with anxiety disorders seeking primary care in a randomized controlled trial The study investigates the effect of patient-driven iCBT treatment of perceptions of being able to control the treatment and on drop-out from treatment In addition secondary research questions investigate measures of empowerment anxiety and depression symptoms general disability satisfaction with treatment and feelings of being able to cope with ones mental illness in patient-driven iCBT
Detailed Description:
The following research questions will be examined
Primary research questions
1 Is there a difference between participants in patient-driven digital psychological treatment compared to standardized internet CBT in perceptions of how much theyve been able to control their treatment measured with a questionnaire developed by the researchers for this study
2 What is the effect of patient-driven digital psychological treatment compared to standardized internet CBT on frequency of completers and completed modules among adults with anxiety disorders
Secondary research questions
3 What is the effect of patient-driven digital psychological treatment compared to standardized internet CBT on the experience of empowerment measured by the Empowerment Scale for adults with anxiety disorders
4 What is the effect of patient-driven digital psychological treatment compared to standardized internet CBT on anxiety measured with GAD-7 depression measured with MADRS-S general disability measured with WHODAS 20 and steps in valued direction measured with Bulls Eye compass for adults with anxiety disorders
Associations
5 Is there a correlation between perceptions of how much one has been able to control the treatment measured with a questionnaire developed by the researchers for this study feelings of being able to cope with ones mental illness measured with Patient Enablement Instrument how satisfied participants are with their treatment measured vid CSQ-8 perceptions of empowerment measured with the Empowerment Scale and changes in anxiety symptoms measured with GAD-7
6 Does perceptions of how much participants have been affected by the pandemic of Covid-19 in their daily life correlate with anxiety symptoms measured with GAD-7 3 months after termination of treatment
Mediation
7 What is the mediating effect of empowerment measured by the Empowerment Scale on changes in anxiety symptoms measured with GAD-7
Primary research questions
1 Is there a difference between participants in patient-driven digital psychological treatment compared to standardized internet CBT in perceptions of how much theyve been able to control their treatment measured with a questionnaire developed by the researchers for this study
2 What is the effect of patient-driven digital psychological treatment compared to standardized internet CBT on frequency of completers and completed modules among adults with anxiety disorders
Secondary research questions
3 What is the effect of patient-driven digital psychological treatment compared to standardized internet CBT on the experience of empowerment measured by the Empowerment Scale for adults with anxiety disorders
4 What is the effect of patient-driven digital psychological treatment compared to standardized internet CBT on anxiety measured with GAD-7 depression measured with MADRS-S general disability measured with WHODAS 20 and steps in valued direction measured with Bulls Eye compass for adults with anxiety disorders
Associations
5 Is there a correlation between perceptions of how much one has been able to control the treatment measured with a questionnaire developed by the researchers for this study feelings of being able to cope with ones mental illness measured with Patient Enablement Instrument how satisfied participants are with their treatment measured vid CSQ-8 perceptions of empowerment measured with the Empowerment Scale and changes in anxiety symptoms measured with GAD-7
6 Does perceptions of how much participants have been affected by the pandemic of Covid-19 in their daily life correlate with anxiety symptoms measured with GAD-7 3 months after termination of treatment
Mediation
7 What is the mediating effect of empowerment measured by the Empowerment Scale on changes in anxiety symptoms measured with GAD-7
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