AnxietyNCT06432114
Sensory Awareness Program
A study testing Sensory Awareness Program (SAP) and Treatment as usual (TAU) in people with Anxiety, run by Lund University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Sensory Awareness Program (SAP) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2022to 2 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acutely mentally unwell
- Cognitively impaired
- Non-Swedish speaking
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Sensory Awareness Program (SAP), Treatment as usual (TAU)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Awareness Program (SAP)Behavioural
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 is standard psychiatric care for the target group.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Awareness Program | Experimental | Not described Receives: Behavioral: Sensory Awareness Program (SAP); Other: Treatment as usual (TAU) |
| Treatment as usual | Other | Not described Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
Secondary outcomes (8)
Hopkins Symptom Checklist-25 (HSCL-25)
The Hopkins Symptoms Checklist (HSCL-25) is a widely used screening instrument with 25 items measuring symptoms of anxiety and depression. The scale for each question includes four response categories from 1 (not at all) to 4 (very much). The total score is the average of all 25 items.
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
Difficulties in Emotion Regulation scale (DERS)
The Difficulties in Emotion Regulation Scale (DERS) is a self-report measure of emotion regulation difficulties. The total score ranges from 16-80 with higher scores indicating more difficulties with emotion regulation.
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
Coping Orientation of Problem Experience Inventory (COPE)
The Brief-COPE is an instrument reflecting individuals' coping strategies when exposed to a stressful situation. Brief-COPE is the short version and consists of 14 sub-scales, with 2 items in each scale, with a total of 28 items. The items are rated on a scale from 1 (seldom) to 4 (very often). In the current study, we will use the three-factor model of the instrument where the 14 subscales are divided into 3 factors; 'Problem-focused coping', 'Emotion-focused coping' and 'Avoidant coping'.
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
Manchester Short Assessment of Quality of Life Scale (MANSA)
The Manchester Short Assessment of Quality of Life (MANSA) consists of 16 questions, covering different domains of life such as physical health, social relationships, employment, and overall life satisfaction. Each question is rated on a scale from 1 to 7, with higher scores indicating better quality of life.
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
Pearlin Mastery Scale
The Pearlin Mastery Scale is used to assess an individual's perceived sense of control over their life circumstances, containing seven questions to rate the level of agreement with statements about the ability to control and influence life. It covers areas such as personal growth, problem-solving, and self-mastery and is rated on a scale from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater levels of mastery.
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
Process of Recovery Questionnaire (QPR-7)
The Process of Recovery Questionnaire (QPR-7) is a short version of the instrument with 15 items (Argentzell et al., 2017). QPR-7 has seven questions concerning which aspects of recovery have been meaningful for the participants on a five-graded scale from 0 (disagree strongly) to 4 (agree strongly).
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
Profiles of Occupationa Engagement (POES)
POES is an instrument that helps to discern the level of occupational engagement. The POES has two parts, one being the 24-hour yesterday time use diary and a second part consisting of a self-rated questionnaire with 9 items representing different components of occupational engagement. Based on the time diary the participants reflect on the content and rate to what extent it corresponds to a lower or higher level of occupational engagement on a 4-point scale.
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a questionnaire used to assess an individual's perceived level of functioning and disability across six domains of life with 12 questions covering: activities and participation in society. Each question is rated on a scale from 0 to 4, with higher scores reflecting greater levels of disability.
Measured: Before intervention, post intervention (at 3 months), 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Mar 2022
- Primary completion2 Mar 2025
- Study completion2 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432114
- Sponsor's protocol ID
- SAP
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40474152
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06432114
- Acronym / sponsor ID
- SAP
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 2 Mar 2025 (actual)
- Study completion
- 2 Mar 2025 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Awareness Program | Experimental | Behavioral: Sensory Awareness Program (SAP), Other: Treatment as usual (TAU) |
| Treatment as usual | Other | Other: Treatment as usual (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Acutely mentally unwell
- Cognitively impaired
- Non-Swedish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Sensory Awareness Program |
| Treatment as usual (TAU)Treatment as usual is standard psychiatric care for the target group. | Other | Sensory Awareness Program, Treatment as usual |
Primary outcome
Becks anxiety inventory (BAI)
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
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.
8 secondary outcomes
Hopkins Symptom Checklist-25 (HSCL-25)
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
Difficulties in Emotion Regulation scale (DERS)
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
Coping Orientation of Problem Experience Inventory (COPE)
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
Manchester Short Assessment of Quality of Life Scale (MANSA)
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
Pearlin Mastery Scale
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
Process of Recovery Questionnaire (QPR-7)
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
Profiles of Occupationa Engagement (POES)
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Before intervention, post intervention (at 3 months), 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 40474152Forsberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Awareness Program (SAP) and Treatment as usual (TAU) in people with Anxiety, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Becks anxiety inventory (BAI) (time frame: Before intervention, post intervention (at 3 months), 6 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06432114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 3 Nov 2026.