Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study
Abstract Background Many patients with posttraumatic stress disorder (PTSD) suffer from sleep problems. Robot-based interventions might be an innovative approach to reduce sleep problems and hyperarousal in PTSD. However, the feasibility and effectiveness of a breath robot in patients with PTSD have...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-023-01426-8 |
| _version_ | 1797275870864343040 |
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| author | Annett Lotzin Isabelle Laskowsky |
| author_facet | Annett Lotzin Isabelle Laskowsky |
| author_sort | Annett Lotzin |
| collection | DOAJ |
| description | Abstract Background Many patients with posttraumatic stress disorder (PTSD) suffer from sleep problems. Robot-based interventions might be an innovative approach to reduce sleep problems and hyperarousal in PTSD. However, the feasibility and effectiveness of a breath robot in patients with PTSD have never been empirically tested. The aim of this study is to investigate the feasibility of a breath robot to reduce sleep problems and hyperarousal in patients with PTSD. Methods This randomized controlled feasibility study will include N = 30 adult patients with at least subsyndromal PTSD (PTSD Symptom Scale – Interview-5 (PSSI-5)) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and impaired sleep quality (Pittsburgh Sleep Quality Index (PSQI) > 5). Patients with organic sleep disorders or currently in psychotherapeutic treatment are excluded. Study participants are randomized to receive either a 4-week Somnox 2 robot intervention including simulation of human breath or a 4-week Somnox 2 robot intervention without human breath simulation. The primary outcome will be the proportion of randomized participants providing outcome data at post-treatment. We consider a proportion of > 50% to indicate feasibility. Additional feasibility outcomes include eligibility rate, recruitment speed, uptake, retention, treatment adherence, and dropout. Potential outcomes of effectiveness (sleep quality, PSQI; severity of PTSD symptoms, PSSI-5) will be assessed at two time points, before (T0) and after (T1) the intervention. Sleep characteristics (Consensus Sleep Diary (CSD)) are measured daily. Discussion This study is the first to investigate the feasibility of a novel breath robot intervention for reducing sleep problems and hyperarousal in PTSD patients, with effectiveness considered as a secondary outcome. If feasible and effective, the use of a breath robot could be a nonintrusive and flexible intervention to supplement psychotherapy or to bridge treatment gaps. Trial registration DRKS, DRKS00031063. Registered on 10/012023. |
| first_indexed | 2024-03-07T15:20:14Z |
| format | Article |
| id | doaj.art-b0a51c19738848838e7303e007940dc4 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-03-07T15:20:14Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-b0a51c19738848838e7303e007940dc42024-03-05T17:43:03ZengBMCPilot and Feasibility Studies2055-57842024-02-011011810.1186/s40814-023-01426-8Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled studyAnnett Lotzin0Isabelle Laskowsky1Department of Psychology, Institute of Clinical Psychology and Psychotherapy Research, MSH Medical School HamburgDepartment of Psychology, Institute of Clinical Psychology and Psychotherapy Research, MSH Medical School HamburgAbstract Background Many patients with posttraumatic stress disorder (PTSD) suffer from sleep problems. Robot-based interventions might be an innovative approach to reduce sleep problems and hyperarousal in PTSD. However, the feasibility and effectiveness of a breath robot in patients with PTSD have never been empirically tested. The aim of this study is to investigate the feasibility of a breath robot to reduce sleep problems and hyperarousal in patients with PTSD. Methods This randomized controlled feasibility study will include N = 30 adult patients with at least subsyndromal PTSD (PTSD Symptom Scale – Interview-5 (PSSI-5)) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and impaired sleep quality (Pittsburgh Sleep Quality Index (PSQI) > 5). Patients with organic sleep disorders or currently in psychotherapeutic treatment are excluded. Study participants are randomized to receive either a 4-week Somnox 2 robot intervention including simulation of human breath or a 4-week Somnox 2 robot intervention without human breath simulation. The primary outcome will be the proportion of randomized participants providing outcome data at post-treatment. We consider a proportion of > 50% to indicate feasibility. Additional feasibility outcomes include eligibility rate, recruitment speed, uptake, retention, treatment adherence, and dropout. Potential outcomes of effectiveness (sleep quality, PSQI; severity of PTSD symptoms, PSSI-5) will be assessed at two time points, before (T0) and after (T1) the intervention. Sleep characteristics (Consensus Sleep Diary (CSD)) are measured daily. Discussion This study is the first to investigate the feasibility of a novel breath robot intervention for reducing sleep problems and hyperarousal in PTSD patients, with effectiveness considered as a secondary outcome. If feasible and effective, the use of a breath robot could be a nonintrusive and flexible intervention to supplement psychotherapy or to bridge treatment gaps. Trial registration DRKS, DRKS00031063. Registered on 10/012023.https://doi.org/10.1186/s40814-023-01426-8Posttraumatic stress disorderBreath robotHyperarousalSleep problemsStress symptomsRandomized controlled trial |
| spellingShingle | Annett Lotzin Isabelle Laskowsky Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study Pilot and Feasibility Studies Posttraumatic stress disorder Breath robot Hyperarousal Sleep problems Stress symptoms Randomized controlled trial |
| title | Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study |
| title_full | Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study |
| title_fullStr | Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study |
| title_full_unstemmed | Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study |
| title_short | Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study |
| title_sort | feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder protocol for a randomized controlled study |
| topic | Posttraumatic stress disorder Breath robot Hyperarousal Sleep problems Stress symptoms Randomized controlled trial |
| url | https://doi.org/10.1186/s40814-023-01426-8 |
| work_keys_str_mv | AT annettlotzin feasibilityofabreathrobotinterventiontoreducesleepproblemsinposttraumaticstressdisorderprotocolforarandomizedcontrolledstudy AT isabellelaskowsky feasibilityofabreathrobotinterventiontoreducesleepproblemsinposttraumaticstressdisorderprotocolforarandomizedcontrolledstudy |