Sensory Awareness Program

NCT ID: NCT06432114

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-03-02

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sensory Awareness Program

Group Type: EXPERIMENTAL

Sensory Awareness Program (SAP)

Intervention Type: BEHAVIORAL

SAP is a new rehabilitation program for people with severe mental health problems. SAP aims to help the target group manage anxiety outburst and live an active life through sensory modulation techniques.

Treatment as usual (TAU)

Intervention Type: OTHER

Treatment as usual is standard psychiatric care for the target group.

Treatment as usual

Group Type: OTHER

Treatment as usual (TAU)

Intervention Type: OTHER

Treatment as usual is standard psychiatric care for the target group.

Interventions

Sensory Awareness Program (SAP)

SAP is a new rehabilitation program for people with severe mental health problems. SAP aims to help the target group manage anxiety outburst and live an active life through sensory modulation techniques.

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

Treatment as usual is standard psychiatric care for the target group.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Region Skåne

Helsingborg, , Sweden

Countries

Sweden

References

Forsberg K, Sutton D, Stjernsward S, Bejerholm U, Argentzell E. Implementation of a sensory modulation intervention in mental health outpatient services: a process evaluation study. BMC Psychiatry. 2025 Jun 5;25(1):581. doi: 10.1186/s12888-025-07034-5.

Reference Type: DERIVED

PMID: 40474152 (View on PubMed)

Other Identifiers

SAP

Identifier Type: -

Identifier Source: org_study_id