Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06259682
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-01-18
Brief Title:
A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia
Sponsor:
Örebro University Sweden
Organization:
Örebro University Sweden
Study Overview
Official Title:
A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia Assessing Acceptability Feasibility and Preliminary Effectiveness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 investigators aim to test the preliminary efficacy as well as the acceptability and feasibility of paradoxical intention which is a psychotherapeutic technique for improving insomnia symptoms in adults Previous research has tested this technique for insomnia and found overall positive results However during the last decades very few studies have examined paradoxical intention Therefore the investigators wish to conduct a pilot study examining the effects in a modern context
Detailed Description:
In the 1970s Ascher and Efran developed paradoxical intention PI instructing sleep onset insomnia patients to stay awake instead of trying to sleep The American Academy of Sleep Medicine confirmed PIs effectiveness However between 2006-2018 PI use in clinical practice declined
The study will investigate PIs acceptability mechanisms and predictors for effectiveness It involves a pilot trial with 40 insomnia patients in Sweden recruited through advertisements and screened through web questionnaires phone interviews and sleep diaries Criteria are based on insomnia research standards and Diagnostic and Statistical Manual Fifth Edition DSM-5 including insomnia with common comorbidities
Participants will undergo baseline assessments then receive four weekly online PI modules including educational texts behavioral experiments and homework Weekly therapist meetings via phone or video will support and troubleshoot issues
Post-treatment 10-15 participants will be randomly selected for qualitative interviews to evaluate their experiences with PI focusing on sleep patterns text volume therapist support and homeworks impact on sleep quality and treatment adherence Interviews will be audio-recorded and analyzed thematically
The study will investigate PIs acceptability mechanisms and predictors for effectiveness It involves a pilot trial with 40 insomnia patients in Sweden recruited through advertisements and screened through web questionnaires phone interviews and sleep diaries Criteria are based on insomnia research standards and Diagnostic and Statistical Manual Fifth Edition DSM-5 including insomnia with common comorbidities
Participants will undergo baseline assessments then receive four weekly online PI modules including educational texts behavioral experiments and homework Weekly therapist meetings via phone or video will support and troubleshoot issues
Post-treatment 10-15 participants will be randomly selected for qualitative interviews to evaluate their experiences with PI focusing on sleep patterns text volume therapist support and homeworks impact on sleep quality and treatment adherence Interviews will be audio-recorded and analyzed thematically
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