Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336551
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-21
Brief Title:
Acceptance and Commitment Therapy for Insomnia
Sponsor:
University of Amsterdam
Organization:
University of Amsterdam
Study Overview
Official Title:
Efficacy of Acceptance and Commitment Therapy as a Stand-Alone Treatment for Insomnia Protocol of a Randomized Waitlist Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Insomnia is a common sleep problem that impacts both physical and mental health Acceptance and Commitment Therapy for Insomnia ACT-I is proposed as a promising new treatment for insomnia However its effectiveness without overlapping behavioral components of the current standard treatment cognitive behavioral therapy remains largely unknown
The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia compared to a waitlist control group The second goal is to explore the potential working mechanisms of ACT-I using network intervention analysis
Adults with insomnia will be randomized to an ACT-I or waitlist group Both the ACT-I treatment and waiting period span 7 weeks Assessments take place at baseline pre after 4 weeks mid and after 8 weeks post followed by a 3- and 6-month follow-up for the ACT-I group
The main questions this RCT aims to answer are
Is ACT-I superior to a waitlist control group in improving insomnia severity primary outcome in addition to sleep diary measures anxiety depression general mental health and sleep-related quality of life secondary outcomes
How do networks of insomnia symptoms or potential treatment processes ie psychological inflexibility sleep-related arousal dysfunctional cognitions and sleep-related safety behaviors develop during and following ACT-I
The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia compared to a waitlist control group The second goal is to explore the potential working mechanisms of ACT-I using network intervention analysis
Adults with insomnia will be randomized to an ACT-I or waitlist group Both the ACT-I treatment and waiting period span 7 weeks Assessments take place at baseline pre after 4 weeks mid and after 8 weeks post followed by a 3- and 6-month follow-up for the ACT-I group
The main questions this RCT aims to answer are
Is ACT-I superior to a waitlist control group in improving insomnia severity primary outcome in addition to sleep diary measures anxiety depression general mental health and sleep-related quality of life secondary outcomes
How do networks of insomnia symptoms or potential treatment processes ie psychological inflexibility sleep-related arousal dysfunctional cognitions and sleep-related safety behaviors develop during and following ACT-I
Detailed Description:
None
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