protocolSection identificationModule nctId: NCT06315660, orgStudyIdInfo id: P-2021-627, briefTitle: VR Based Therapy to Treat Anxiety in Dual Diagnosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Mental Health Centre Sct. Hans, class: OTHER_GOV, descriptionModule briefSummary: Dual diagnosis refers to patients with both severe mental illness and substance abuse. Dual diagnosis is therefore a challenging condition to treat, and the group typically represents the most vulnerable individuals in society. Historically, research on dual diagnosis has been underprioritized, and thus, we still do not know enough about how to best assist this vulnerable group.However, new studies indicate that virtual reality programs can reduce anxiety in patients with psychotic disorders. They achieve this by providing access to a virtual therapist and lifelike environments where patients can challenge their thoughts about the dangers of navigating the world. For both psychotic disorders and substance abuse, we know that anxiety often plays a role in the clinical picture. Therefore, anxiety almost always has an impact on dual diagnosis patients, where it is crucial in maintaining substance abuse and functional impairment. Despite this, anxiety is rarely a focus in existing treatment options, as it is too resource-intensive in addition to an already intensive treatment process.This study investigates whether the resource barrier can be overcome and whether hospitalized dual diagnosis patients can experience reduced anxiety, fewer relapses, and better outcomes after discharge when their anxiety is treated through partially automated virtual reality therapy., conditionsModule conditions: Dual Diagnosis, conditions: Psychosis, conditions: Agoraphobia, conditions: Social Anxiety Disorder, conditions: Substance Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a parallel group, investigator initiated, pragmatic, assessor-blinded, 1:1 randomized, clinical feasibility trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: When a participant is randomized to TAU+VR, the senior researcher reveals the allocation to the assigned clinician via secure e-mail. The assigned clinician then schedules the eight therapy sessions with the participant who is thus unblinded to their treatment allocation. If the participant is randomized to TAU, the assigned clinician will inform the participant as soon as possible. The researchers collecting data from the patient and the researchers performing data analysis remain blinded. There are no circumstances wherein unblinding of outcome assessors or data analysists is permissible., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Miljeu Therapy, interventions name: Virtual Reality based CBT for Anxiety, outcomesModule primaryOutcomes measure: Oxford Agoraphobic Avoidance Scale, primaryOutcomes measure: Client Satisfaction Questionnaire, primaryOutcomes measure: Systems Useability Scale, secondaryOutcomes measure: Timeline Followback, secondaryOutcomes measure: The Six-item Positive and Negative Symptom Syndrome Scale, secondaryOutcomes measure: The Social Functioning Scale, secondaryOutcomes measure: The Questionnaire about the Process of Recovery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False