Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432114
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-17
Brief Title:
Sensory Awareness Program
Sponsor:
Lund University
Organization:
Lund University
Study Overview
Official Title:
Coping Through Sensory Modulation A Sensory Awareness Program SAP for Reducing Anxiety and Mobilizing Coping Strategies for People With Severe Mental Health Problems A Randomized 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:
Few alternatives to addictive medical treatment exists for persons with severe mental health problems SMHP and anxiety often connected to high risk of suicide Access to effective interventions that depart in individuals needs to cope with anxiety in everyday life is crucial to provide and desperately warranted by service users Service users are often unaware of sensory needs connected to anxiety outburst The Sensory Awareness Program SAP is a group-based self-management intervention of 10 weeks developed to meet complex needs of regulating anxiety and related self-destructive behaviors SAP stems from theories on sensory modulation and is an approach to manage physiological arousal associated with anxiety through self-regulated sensory-based coping strategies International research show that sensory modulation is effective both as a method to reduce anxiety and thus restraint in acute mental health services MHS and also to empower users However much research to date focus on using sensory strategies within wards International research and pre-studies of testing the SAP in outpatient MHS indicate that it is a promising self-management intervention to support everyday life Earlier studies further show that users unawareness of sensory needs triggers anxiety and that anxiety itself is the main contributing factor for disrupting everyday life Also staff acknowledge sensory modulation but lack knowledge on whether programs such as SAP is effective and possible to implement
The overall aim is to investigate the effectiveness of SAP as compared to treatment as usual TAU among 200 outpatients The investigators hypothesize that SAP will be more effective than TAU in terms of reduced anxiety primary outcome at three months follow-up Secondary clinical and personal recovery outcomes post intervention and at three and six months follow up will also be targeted and assumed to be in favour of the SAP group The implementation process of the SAP will also be explored
The overall aim is to investigate the effectiveness of SAP as compared to treatment as usual TAU among 200 outpatients The investigators hypothesize that SAP will be more effective than TAU in terms of reduced anxiety primary outcome at three months follow-up Secondary clinical and personal recovery outcomes post intervention and at three and six months follow up will also be targeted and assumed to be in favour of the SAP group The implementation process of the SAP will also be explored
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