{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T08:18:29Z","timestamp":1765009109392,"version":"3.46.0"},"reference-count":46,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T00:00:00Z","timestamp":1663113600000},"content-version":"unspecified","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,8,19]]},"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Depression is a common mental disorder and the (global) leading cause of all non-fatal burden of disease worldwide. Currently, supported treatment for depression is antidepressant medication and different psychotherapeutic interventions. Many patients experience, however, adverse effects of antidepressant medication, while at the same time the access to psychotherapeutic interventions are limited. Many patients who suffer from depression turn to complementary medicine and among those modalities often spiritual healing. There is some evidence that consulting a spiritual healer can be beneficial for patients who suffer from depression, and that spiritual healing is associated with low risk. The aim of this protocol is to conduct a pilot randomised controlled trial (RCT) (spiritual healing as addition to usual care vs usual care alone) in preparation of a larger trial in adults with moderate depression, to examine feasibility and individuals\u2019 experience of spiritual healing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This study is a pilot RCT with two parallel groups. A total of 28 adult patients with moderate depression, diagnosed by the physician and according to the Montgomery and \u00c5sberg Depression Rating Scale criteria will be randomised to spiritual healing in addition to usual care (n=14) or usual care alone (n=14). To determine if there is a statistical indication of an effect of healing warranting a full-scale study; the separation test will be used. To investigate participants\u2019 experience with spiritual healing, a qualitative study will be included using semistructured interviews. The data will be analysed based on a direct content analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This protocol was approved by regional committees for medical and health research ethics by the identifier (63692). The results will be disseminated through open-access, peer-reviewed publications, in addition to stakeholders\u2019 reporting and presenting at conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Norwegian Centre for Research Data (845302) and clinicaltrials.gov (ID:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04766242\">NCT04766242<\/jats:ext-link>\n                      )\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-062683","type":"journal-article","created":{"date-parts":[[2022,9,15]],"date-time":"2022-09-15T11:02:29Z","timestamp":1663239749000},"page":"e062683","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Impact of spiritual healing on moderate depression in adults: a study protocol of a pilot randomised controlled trial (RCT)"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04766242","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04766242","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7053-509X","authenticated-orcid":false,"given":"Trine","family":"Stub","sequence":"first","affiliation":[{"name":"Department of Community Medicine, UiT The Arctic University of Norway, National Research Center in Complementary and Alternative Medicine, Tromso, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Audun Campell","family":"Irgens","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, S\u00f8rlandet sykehus HF Arendal, Arendal, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne Helen","family":"Hansen","sequence":"additional","affiliation":[{"name":"University Hospital of North Norway, Tromso, Norway"},{"name":"Department of Community Medicine, UiT The Arctic University of Norway, Tromso, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olav","family":"Knudsen-Baas","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, S\u00f8rlandet sykehus HF Arendal, Arendal, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cornelia","family":"G\u00e5skjenn","sequence":"additional","affiliation":[{"name":"Emergency Room, Arendal Kommune, Arendal, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Agnete E","family":"Kristoffersen","sequence":"additional","affiliation":[{"name":"Department of Community Medicine, UiT The Arctic University of Norway, National Research Center in Complementary and Alternative Medicine, Tromso, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,9,15]]},"reference":[{"key":"2025120600131858000_12.9.e062683.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)61611-6"},{"key":"2025120600131858000_12.9.e062683.2","unstructured":"Mykletun A , Knudsen AK , Mathiesen KS . Psykiske lidelser i Norge: Et folkehelseperspektiv [Mental disorders in Norway: A public health perspective. Oslo: Norwegian Institute of Public Health, 2009."},{"key":"2025120600131858000_12.9.e062683.3","unstructured":"Breedlove SM , Rosenzweig MR , Watson NV . Biological psychology: an introduction to behavioral, cognitive, and clinical neuroscience. In: Mass: Sinauer associates. 5th. 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Oslo: Gyldendal Norsk Forlag AS, 2004."},{"key":"2025120600131858000_12.9.e062683.21","unstructured":"Helsedirektoratet . Depresjon 2016 27 01. Available: https:\/\/helsedirektoratet.no\/folkehelse\/psykisk-helse-og-rus\/angst-og-depresjon\/depresjon [Accessed 27 Jan 2017]."},{"key":"2025120600131858000_12.9.e062683.22","unstructured":"Nasjonalt forskningssenter innen komplement\u00e6r og alternativ medisin (NAFKAM) . NAFKAM-unders\u00f8kelsen 2014, Bruk av alternativ behandling i Norge [The nafkam survey 2014. Use of complementary and alternative medisin in Norway] Troms\u00f8: Nasjonalt informasjonssenter for alternativ behandling (NIFAB); 2014. Available: http:\/\/nifab.no\/hva_er_alternativ_behandling\/tall_og_fakta\/nafkam_undersoekelsen_2014 [Accessed 30 Jan 2015]."},{"key":"2025120600131858000_12.9.e062683.23","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1016\/j.ctcp.2009.11.001","article-title":"Emerging from depression: the experiential process of healing touch explored through grounded theory and case study","volume":"16","author":"Van Aken","year":"2010","journal-title":"Complement Ther Clin Pract"},{"key":"2025120600131858000_12.9.e062683.24","unstructured":"MacPherson H , Hammerschlag R , Lewith G . Acupuncture research strategies for establishing an evidence base. 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