Clinical trial NCT06432114: Sensory Awareness Program
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Be assigned to a MHS
* Age over 18
* Having SMHP (including a diagnosis of mood disorder, anxiety disorder, eg PTSD, panic disorder etc, and/or psychotic disorder)
* Experience anxiety

Exclusion Criteria:

* Acutely mentally unwell
* Cognitively impaired
* Non-Swedish speaking

Primary outcomes:
measure: Becks anxiety inventory (BAI)
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
Secondary outcomes:
measure: Hopkins Symptom Checklist-25 (HSCL-25)
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
measure: Difficulties in Emotion Regulation scale (DERS)
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
measure: Coping Orientation of Problem Experience Inventory (COPE)
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
measure: Manchester Short Assessment of Quality of Life Scale (MANSA)
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
measure: Pearlin Mastery Scale
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
measure: Process of Recovery Questionnaire (QPR-7)
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
measure: Profiles of Occupationa Engagement (POES)
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
measure: The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Before intervention, post intervention (at 3 months), 6 and 9 months
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Region Skåne
Study officials:
References: