[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656324":3},{"organization":4,"outcomesModule":7,"designInfo":127,"detailedDescription":137,"studyPopulation":132,"armGroups":138,"interventions":151,"overallOfficials":132,"centralContacts":165,"locations":171,"responsibleParty":187,"collaborators":132,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":193,"sex":199,"minAge":200,"maxAge":132,"enrollmentInfo":201,"targetDuration":132,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":214,"whyStopped":132,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":112},[9],{"measure":10,"description":11,"timeFrame":12},"Change in depressive symptoms (MADRS total score)","Mean change from baseline to week 12 in depressive symptoms measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a clinician-rated 10-item scale (0-6 per item; total score range 0-60), with higher scores indicating more severe depression.","Baseline to week 12",[14,18,22,25,29,32,36,40,43,46,49,52,55,58,61,64,68,72,76,80,84,88,91,94,98,102,106,109],{"measure":15,"description":16,"timeFrame":17},"MADRS response and remission","Proportion of participants achieving response and remission at week 12 based on MADRS total score. Response is defined as ≥50% reduction from baseline. Remission is defined as MADRS \\\u003C11.","Week 12",{"measure":19,"description":20,"timeFrame":21},"Self-reported depressive symptoms (MADRS-S)","Change over time in self-reported depressive symptoms measured with the Montgomery-Åsberg Depression Rating Scale - Self-rated (MADRS-S). The MADRS-S is a 9-item scale (0-6 per item; total score range 0-54), with higher scores indicating more severe depression.","Baseline, weeks 2, 3, 4, 5, 8, 12, and month 6",{"measure":23,"description":24,"timeFrame":21},"Suicidal ideation (MADRS-S item 9)","Change over time in self-reported suicidal ideation measured by item 9 of the MADRS-S (score 0-6; higher scores indicate greater severity).",{"measure":26,"description":27,"timeFrame":28},"Time to hospitalization","Time from baseline to first hospitalization due to depression during follow-up","Baseline to 12 months",{"measure":30,"description":31,"timeFrame":12},"Adverse events and treatment discontinuation","Incidence of adverse events (mild, moderate, severe) and time to treatment discontinuation for any reason.",{"measure":33,"description":34,"timeFrame":35},"Ketamine-related adverse effects (Modified KSET)","Ketamine-related adverse effects measured with a modified version of the Ketamine Side Effect Tool (KSET), a 20-item patient-rated scale (0-3 per item; higher scores indicate greater side effect burden).","Week 1 and week 4",{"measure":37,"description":38,"timeFrame":39},"Quality of life and health (VAS)","Change in self-rated quality of life and health measured with a visual analogue scale from 0 to 100, where higher scores indicate better perceived quality of life and health.","Baseline, weeks 2, 3, 4, 5, 8, 12, and months 6 and 12",{"measure":41,"description":42,"timeFrame":12},"Satisfaction with life","Life satisfaction measured with the Satisfaction With Life Scale (SWLS). The SWLS has 5 items rated on a 7-point scale, with total scores ranging from 5 to 35. Higher scores indicate greater life satisfaction.",{"measure":44,"description":45,"timeFrame":12},"Subjective sleep quality","Subjective sleep quality measured with the Brief Pittsburgh Sleep Quality Index (B-PSQI). The questionnaire asks about sleep habits during the previous month and includes bedtime, sleep latency, wake time, sleep duration, nighttime sleep problems, overall sleep quality, and use of sleep medication. Higher scores indicate worse sleep quality.",{"measure":47,"description":48,"timeFrame":12},"Perceived social support","Perceived social support measured with the Social Provisions Scale-5 (SPS-5). The scale has 5 items rated on a 4-point scale from 1 to 4, with total scores ranging from 5 to 20. Higher scores indicate greater perceived social support.",{"measure":50,"description":51,"timeFrame":12},"Loneliness","Loneliness measured with the UCLA Loneliness Scale, 3-item version. The scale has 3 items rated from 1 to 3, with total scores ranging from 3 to 9. Higher scores indicate greater loneliness.",{"measure":53,"description":54,"timeFrame":12},"Screen time","Screen time measured with the Screen Time questionnaire (ScrT), which assesses average daily time spent on social media, gaming, TV\u002Fstreaming, and background TV\u002Fstreaming use. Higher response categories indicate more screen exposure.",{"measure":56,"description":57,"timeFrame":12},"Absorption","Trait absorption measured with the Modified Tellegen Absorption Questionnaire (MODTAS). The questionnaire assesses tendency to become fully absorbed in sensory, imaginative, or experiential activities; higher scores indicate greater absorption.",{"measure":59,"description":60,"timeFrame":12},"Trait anxiety","Trait anxiety measured with the State-Trait Anxiety Inventory short form (STAI-SF). Higher scores indicate greater anxiety-proneness.",{"measure":62,"description":63,"timeFrame":12},"Cognitive fusion","Cognitive fusion measured with the Cognitive Fusion Questionnaire (CFQ-7). The questionnaire has 7 items rated on a 7-point scale; total scores range from 7 to 49. Higher scores indicate greater cognitive fusion, meaning more entanglement with thoughts and less psychological flexibility.",{"measure":65,"description":66,"timeFrame":67},"Goal attainment for behavioral activation","Goal attainment measured with the Goal Attainment Scale for Depression (GAS-D). Individual goals are rated on a 5-point scale from -2 to +2, where 0 reflects expected goal attainment and higher scores indicate better-than-expected attainment.","Week 1, 2, 3, 4, 5, 6, 8 and 12",{"measure":69,"description":70,"timeFrame":71},"Therapeutic alliance","Therapeutic alliance measured with the Working Alliance Inventory - Short Revised (WAI-SR) completed by participants and the Working Alliance Inventory - Short form (WAI-SRT) completed by clinicians. The instruments assess the quality of the working relationship across goal agreement, task agreement, and bond. Higher scores indicate a stronger therapeutic alliance.","baseline, week 2, 6 and 12",{"measure":73,"description":74,"timeFrame":75},"Acute mystical and challenging experiences","Acute ketamine-related subjective experiences measured after each infusion with the Mystical Experience Questionnaire short form (MEQ-4) and the Challenging Experience Questionnaire short form (CEQ-7). The MEQ-4 is a 4-item self-report measure of mystical-type experience, scored 0 to 5 per item, with higher scores indicating a stronger mystical experience. The CEQ-7 is a 7-item self-report measure of challenging experience, scored 0 to 5 per item, with higher scores indicating a more difficult or distressing experience.","Immediately after each of 6 infusions during weeks 1 to 4",{"measure":77,"description":78,"timeFrame":79},"Mystical experience","Mystical experience measured with the Mystical Experience Questionnaire (MEQ-30). The MEQ-30 is a 30-item self-report questionnaire scored on a 0 to 5 scale and assesses mystical-type experience across domains such as unity, sacredness, positive mood, transcendence of time and space, and ineffability. Higher scores indicate a stronger mystical experience.","Week 5",{"measure":81,"description":82,"timeFrame":83},"Expectancy","Treatment expectation measured with patient- and clinician-rated treatment expectation questionnaires. The patient questionnaire and clinician questionnaire assess expected benefit from treatment and perceived treatment credibility. Higher scores indicate greater treatment expectancy.","Baseline, week 1 and 2",{"measure":85,"description":86,"timeFrame":87},"Drug liking and perceived drug effects","Acute drug effects measured with the Drug Effect Questionnaire (DEQ). The DEQ uses 0 to 100 visual analogue ratings to assess perceived drug effect, feeling high, liking and disliking effects, and desire for more drug. Higher scores indicate stronger perceived drug effects and greater drug liking or desire for more drug, depending on the item.","Immediately after infusion 2 and infusion 6 during weeks 1 and 4",{"measure":89,"description":90,"timeFrame":79},"Altered states of consciousness","Altered states of consciousness measured with the 5-Dimensional Altered States of Consciousness Scale (5D-ASC). The 5D-ASC assesses five dimensions of altered consciousness; higher scores indicate a more intense altered state in the relevant dimension.",{"measure":92,"description":93,"timeFrame":79},"Psychological insight","Psychological insight measured with the Psychological Insight Scale (PIS). The PIS contains 7 items rated from 0 to 100 and assesses new insight into one's past, self, lifestyle, and behavior change. Higher scores indicate greater psychological insight.",{"measure":95,"description":96,"timeFrame":97},"Treatment evaluation","Treatment evaluation measured with patient- and clinician-rated treatment evaluation questionnaires. These questionnaires assess overall appraisal of the treatment experience and perceived usefulness of the intervention. Higher scores indicate a more positive treatment evaluation.","Week 6",{"measure":99,"description":100,"timeFrame":101},"Personality traits","Personality measured with the Ten-Item Personality Inventory (TIPI). The TIPI is a 10-item self-report measure of the Big Five personality traits: extraversion, emotional stability, agreeableness, conscientiousness, and openness to experience. It is administered as a baseline covariate; higher trait scores indicate more of the relevant personality dimension.","Baseline",{"measure":103,"description":104,"timeFrame":105},"Substance-related convictions or diagnoses","Occurrence of a drug-related conviction or substance use disorder diagnosis during follow-up.","12 months",{"measure":107,"description":108,"timeFrame":105},"Work ability and social transfers","Employment-related income and social transfer dependence during follow-up, assessed as income net of social transfers.",{"measure":110,"description":111,"timeFrame":105},"Psychotropic medication use","Average daily defined dose of prescribed psychotropic medication during follow-up.",[113,117,121,124],{"measure":114,"description":115,"timeFrame":116},"Subjective ketamine experience interview","Subjective ketamine experience assessed with a semi-structured post-infusion interview in the psychedelic treatment group only. The interview explores sensory experiences, emotions, thought control, self-body experience, space, time, mystical or spiritual experiences, changes in meaning, and post-session insight. Interview reports will be transcribed and content-analyzed to derive quantitative and thematic results.","After infusion 1, infusion 3, and infusion 6 during weeks 1, 2, and 4",{"measure":118,"description":119,"timeFrame":120},"Acute dissociative symptoms","Dissociative symptoms measured with the Clinician Administered Dissociative States Scale (CADSS) in the biomedical treatment group only. The CADSS is a clinician-administered scale with 23 items rated 0 to 4, assessing experiences such as depersonalization, derealization, altered body perception, altered sense of time, and memory gaps. Higher scores indicate greater dissociation.","After each of 6 infusions during weeks 1 to 4",{"measure":122,"description":123,"timeFrame":120},"Acute psychiatric symptoms","Acute psychiatric symptoms measured with the Brief Psychiatric Rating Scale (BPRS) in the biomedical treatment group only. The BPRS is a clinician-rated interview scale assessing symptoms such as anxiety, depression, hostility, unusual thought content, hallucinations, and disorganization. Higher scores indicate greater psychiatric symptom severity.",{"measure":125,"description":126,"timeFrame":28},"Incremental costs associated with psychedelic versus biomedical framing","Incremental intervention-related and healthcare costs associated with psychedelic framing compared with biomedical framing.",{"allocation":128,"interventionModel":129,"interventionModelDescription":130,"primaryPurpose":131,"observationalModel":132,"timePerspective":132,"maskingInfo":133},"RANDOMIZED","PARALLEL","Participants are randomized 1:1 to receive ketamine treatment with either psychedelic framing or biomedical framing. The ketamine dosing and infusion schedule are identical in both groups; only the framing and supporting context differ.","TREATMENT",null,{"masking":134,"maskingDescription":132,"whoMasked":135},"SINGLE",[136],"OUTCOMES_ASSESSOR","Ketamine is increasingly used in the treatment of treatment-resistant depression. In this study, ketamine is administered in the same clinical manner in both groups, but the treatment context differs. One group receives a psychedelic framing that presents subjective ketamine experiences as potentially meaningful and therapeutically relevant, while the other group receives a biomedical framing that presents ketamine as a pharmacological treatment and subjective effects as side effects. The study compares the effects of these two framings on depressive symptoms, treatment experience, tolerability, and selected longer-term outcomes measured through follow-up assessments and national registers.",[139,145],{"label":140,"type":141,"description":142,"interventionNames":143},"Biomedical framing of ketamine treatment","ACTIVE_COMPARATOR","Participants view a brief video presenting ketamine treatment from a biomedical perspective, emphasizing its pharmacological antidepressant effects. Potential side effects are described, and participants are informed that clinical support will be provided throughout treatment with the aim of alleviating these effects.\n\nA healthcare professional is present during all six ketamine infusions. The staff member provides psychological support, helps reduce anxiety, and assists the participant in managing or distracting from side effects such as distressing dissociation. Infusions may be paused if needed. After each infusion, participants are assessed for side effects using the Clinician-Administered Dissociative States Scale (CADSS) and the Brief Psychiatric Rating Scale (BPRS).\n\nParticipants may choose to use music and\u002For an eye mask during the infusion if they wish, but these are not actively provided or encouraged by the treatment staff.",[144],"Behavioral: Biomedical framing",{"label":146,"type":147,"description":148,"interventionNames":149},"Psychedelic framing of ketamine treatment","EXPERIMENTAL","Participants view a brief video presenting ketamine treatment from a psychedelic perspective, in which the subjective psychoactive effects are described as potentially meaningful and therapeutically relevant. Participants are informed that supportive presence will be provided throughout the session.\n\nA healthcare professional is present during all six ketamine infusions. The staff member provides psychological support, encourages participants to engage with their inner experience, and offers reassurance when needed. Infusions may be paused if needed. The treatment setting includes optional supportive elements such as a short mindfulness practice, music and eye mask to facilitate inward focus.\n\nAfter each infusion, participants are invited to reflect on their experience through a semi-structured interview, with clinician time matched to the CADSS and BPRS assessments conducted in the comparator arm.",[150],"Behavioral: Psychedelic framing",[152,160],{"type":153,"name":154,"description":155,"armGroupLabels":156,"otherNames":157},"BEHAVIORAL","Psychedelic framing","The intervention includes:\n\n* Psychedelic framed patient information (video)\n* Psychedelic environment during infusions (mindfulness practice, music, eye mask) and psychological support provided towards engaging in the inner experience\n* Interview on the ketamine-induced experience",[146],[158,159],"Contextual framing","Treatment setting",{"type":153,"name":161,"description":162,"armGroupLabels":163,"otherNames":164},"Biomedical framing","The intervention includes:\n\n* Biomedically framed patient information (video)\n* Psychological support provided during the infuion towards alleviating side effects such as dissociation\n* CADSS and BPRS",[140],[158,159],[166],{"name":167,"role":168,"phone":169,"phoneExt":132,"email":170},"Alexandra Leinonen, MD","CONTACT","+46706371348","alexandra.leinonen@gu.se",[172],{"facility":173,"status":132,"city":174,"state":175,"zip":176,"country":177,"countryCode":178,"cosmosGeoPoint":179,"geoPoint":184,"contacts":185},"Brain Stimulation Clinic, Skaraborg's Hospital","Skövde","Västra Götaland County","54160","Sweden","SE",{"type":180,"coordinates":181},"Point",[182,183],13.84506,58.39118,{"lat":183,"lon":182},[186],{"name":167,"role":168,"phone":169,"phoneExt":132,"email":170},{"type":188,"investigatorFullName":189,"investigatorTitle":190,"investigatorAffiliation":5,"oldNameTitle":132,"oldOrganization":132},"SPONSOR_INVESTIGATOR","Valdemar Landgren","PhD, psychiatrist","100656324","ketamine-treatment-for-treatment-resistant-depression---the-role-of-framing-100656324",false,"NCT07824973","Ketamine Treatment for Treatment-Resistant Depression - the Role of Framing","A Single-center Open-label Randomized Parallel-group Superiority Trial to Compare the Efficacy of Psychedelic and Biomedical Framing of Intravenous Ketamine for Treatment-resistant Depression - the KetSet Trial","KetSet","Inclusion Criteria:\n\n* Prescribed ketamine treatment for depression\n* Able to understand study information and provide informed consent\n\nExclusion Criteria:\n\n\\- Patients who do not meet the inclusion criteria","ALL","18 Years",{"count":202,"type":203},120,"ESTIMATED","INTERVENTIONAL",[206],"NA","Ketamine is a medicine used in psychiatry for treatment-resistant depression. This study compares two ways of framing ketamine treatment: a psychedelic framing and a biomedical framing. The study will examine whether the framing affects depressive symptoms, treatment experience, tolerability, and longer-term outcomes.",[209],"Treatment Resistant Depression (TRD)",[211,212,213],"ketamine","psychological framing","psychedelic","NOT_YET_RECRUITING","2026-09-11",{"date":217,"type":218},"2026-09-17","ACTUAL",{"date":220,"type":203},"2026-09",{"date":222,"type":203},"2030-08",{"name":189,"class":6},1]