VR Based Therapy to Treat Anxiety in Dual Diagnosis

NCT06315660 | Not Yet Recruiting DMC

• 1 other identifier: P-2021-627
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dual Diagnosis; Psychosis; Agoraphobia; Social Anxiety Disorder; Substance Use Disorder

Outcome Measures

Primary Outcomes (3)

• Oxford Agoraphobic Avoidance Scale

  The Oxford Agoraphobic Avoidance Scale is a psychometrically validated short-form questionnaire designed specifically to assess anxious avoidance and distress in a population with psychosis

  From enrollment to 3 month post treatment (16.9 weeks)

• Client Satisfaction Questionnaire

  The Client Satisfaction Questionnaire is an 8-item scale loading to one factor of satisfaction with mental healthcare service.

  From enrollment to post treatment (4 to 8 weeks)

• Systems Useability Scale

  The System Usability Scale is a standardized questionnaire designed to provide a quick measure of the user's subjective perception of the usability of a computer system. It will be administered to clinical staff after treatment.

  From enrollment to post treatment (4 to 8 weeks)

Secondary Outcomes (4)

• Timeline Followback

  From enrollment to 3 month post treatment (16.9 weeks)

• The Six-item Positive and Negative Symptom Syndrome Scale

  From enrollment to 3 month post treatment (16.9 weeks)

• The Social Functioning Scale

  From enrollment to 3 month post treatment (16.9 weeks)

• The Questionnaire about the Process of Recovery

  From enrollment to 3 month post treatment (16.9 weeks)

Study Arms (2)

TAU+VR

EXPERIMENTAL

Behavioral: Cognitive Miljeu Therapy; Behavioral: Virtual Reality based CBT for Anxiety

TAU

ACTIVE COMPARATOR

Behavioral: Cognitive Miljeu Therapy

Interventions

Cognitive Miljeu Therapy BEHAVIORAL

TAU is an integrated voluntary inpatient treatment based on the principles of CBT, lasting between 12-20 weeks. This treatment includes exercise, close medical monitoring, group-based CBT for SUD, planning with social services, and is called Cognitive Milieu Therapy.

TAU; TAU+VR

Virtual Reality based CBT for Anxiety BEHAVIORAL

The experimental intervention is a manualized add-on to TAU and comprises eight sessions of 60 minutes over a period of four weeks. Of these eight sessions, six will include 30 minutes of VR-based behavioral experiments targeting agoraphobic and social fear.

TAU+VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (+18 years) admitted to the standard dual diagnosis treatment program in the Mental Health Services of the Capital Region of Denmark.
• Fulfilling diagnostic criteria for a F20-29 disorder and dependence syndrome of either alcohol or drugs in the ICD-10 diagnostic manual.
• Scoring 6 or above on the avoidance subscale and 66 or above on the distress subscale scale of the O-AS. This corresponds to severe levels of avoidance and distress36.

You may not qualify if:

• Incapable of providing informed consent.
• Insufficient knowledge of the Danish and/or English language.

Sponsors & Collaborators

• Mental Health Centre Sct. Hans: lead

MeSH Terms

Conditions

Psychotic Disorders; Agoraphobia; Phobia, Social; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Phobic Disorders; Anxiety Disorders; Chemically-Induced Disorders

Study Officials

• Benjamin Arnfred, phd

  Mental Health Centre St. Hans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Arnfred, phd

CONTACT

31724603; barn0006@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study is a parallel group, investigator initiated, pragmatic, assessor-blinded, 1:1 randomized, clinical feasibility trial.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03