Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05679362
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2022-12-16
Brief Title:
Online Brief CBT Intervention for Women With PCOS
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
How 2 Deal With PCOS a Randomized Online Intervention for Women With PCOS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
How2deal
Brief Summary:
Primary Objective
-To study if an online individual brief CBT group A intervention is effective for psychological distress anxiety and depression compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline
Secondary Objectives
1 To study if an online group based brief CBT group B is more effective for anxiety and depression compared to CAU in patients with PCOS at 3 and 6 months relative to baseline
2 To determine if an online individual brief CBT group A is effective for improvements in QoL coping strategies body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline
3 To determine if an group based brief CBT group B is more effective for improvements in QoL coping strategies body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline
4 If A and B are effective compared to CAU we will compare online individual brief CBT group A to online group based brief CBT group B for anxiety and depression QoL coping strategies body image and sleep quality compared to in patients with PCOS at 3 and 6 months relative to baseline
-To study if an online individual brief CBT group A intervention is effective for psychological distress anxiety and depression compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline
Secondary Objectives
1 To study if an online group based brief CBT group B is more effective for anxiety and depression compared to CAU in patients with PCOS at 3 and 6 months relative to baseline
2 To determine if an online individual brief CBT group A is effective for improvements in QoL coping strategies body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline
3 To determine if an group based brief CBT group B is more effective for improvements in QoL coping strategies body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline
4 If A and B are effective compared to CAU we will compare online individual brief CBT group A to online group based brief CBT group B for anxiety and depression QoL coping strategies body image and sleep quality compared to in patients with PCOS at 3 and 6 months relative to baseline
Detailed Description:
The online brief CBT intervention is designed to address three problems that have often been reported in women with PCOS Therefore the program contains three themes Psychoeducation about PCOS traditional CBT and problem-solving therapy
Participants are randomized into one of three groups
1 individual treatment A
2 group treatment B
3 care as usual CAU
Treatment A and B include 5 sessions divided over a period of 3 months
Week 1 Session 1 homework assignments Week 3 Session 2 homework assignments Week 5 Session 3 homework assignments Week 8 Session 4 homework assignments Week 12 Session 5 homework assignments
The CAU group receives standard treatment for depressive symptoms from their general practitioner GP
Participants are randomized into one of three groups
1 individual treatment A
2 group treatment B
3 care as usual CAU
Treatment A and B include 5 sessions divided over a period of 3 months
Week 1 Session 1 homework assignments Week 3 Session 2 homework assignments Week 5 Session 3 homework assignments Week 8 Session 4 homework assignments Week 12 Session 5 homework assignments
The CAU group receives standard treatment for depressive symptoms from their general practitioner GP
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