Sensory Awareness Program

NCT06432114 | Completed

• 1 other identifier: SAP
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Becks anxiety inventory (BAI)

  The Beck Anxiety Inventory (BAI) is a self-report questionnaire measuring the severity of anxiety symptoms with 21 questions, each describing a symptom of anxiety. The participant rates each item on a scale from 0 to 3, indicating how much he/she experiences each symptom. The scores range from 0 to 63, with higher scores indicating more severe levels of anxiety.

  Before intervention, post intervention (at 3 months), 6 and 9 months

Secondary Outcomes (8)

• Hopkins Symptom Checklist-25 (HSCL-25)

  Before intervention, post intervention (at 3 months), 6 and 9 months

• Difficulties in Emotion Regulation scale (DERS)

  Before intervention, post intervention (at 3 months), 6 and 9 months

• Coping Orientation of Problem Experience Inventory (COPE)

  Before intervention, post intervention (at 3 months), 6 and 9 months

• Manchester Short Assessment of Quality of Life Scale (MANSA)

  Before intervention, post intervention (at 3 months), 6 and 9 months

• Pearlin Mastery Scale

  Before intervention, post intervention (at 3 months), 6 and 9 months

Study Arms (2)

Sensory Awareness Program

EXPERIMENTAL

Behavioral: Sensory Awareness Program (SAP); Other: Treatment as usual (TAU)

Treatment as usual

OTHER

Other: Treatment as usual (TAU)

Interventions

Treatment as usual (TAU) OTHER

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

Sensory Awareness Program; Treatment as usual

Sensory Awareness Program (SAP) 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.

Sensory Awareness Program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male, female, non-binary
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Region Skåne

Helsingborg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 40474152 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 29, 2024
• Study Start: March 1, 2022
• Primary Completion: March 2, 2025
• Study Completion: March 2, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

SE (1)