Virtual Reality cognitive behavioral therapy for paranoid delusions - a randomized effect study

Virtual Reality cognitive behavioral therapy for paranoid delusions - a randomized effect study - VR CBT for psychosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48557

Enrollment

106

Registered

2019-04-18

Start date

2019-07-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychosis psychotic disorders

Interventions

VRcbt consists of maximum 16 sessions in virtual social situations that trigger paranoid ideations and distress, delivered in an 8-12 week time frame. Standard CBT also consists of maximum 16 sessio

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - DSM-5 diagnosis of schizophrenia spectrum or other psychotic disorder. - At least a moderate level of paranoid ideations (Green Paranoid Thoughts Scale >40). - Age 18-65.

Exclusion criteria

Exclusion criteria: - IQ under 70. - Insufficient command of Dutch language. - Received Cognitive Behavioral Therapy for paranoid delusions in past 12 months.

Design outcomes

Primary

Measure	Time frame
Primary outcome is level of paranoid ideations in daily life social situations, measured with ecological momentary assessments (EMA) at semi-random moments ten times a day during seven days, before and after treatment.	—

Secondary

Measure	Time frame
Mean scores before and after treatment on GPTS, SIAS, PSYRATS, SBQ, PSWQ, SERS, IPSM, BCSS and DACOBS will be compared between conditions. Cost-effectiveness analyses (CEA) will be conducted using TiC-P and EQ-5D-5L questionnaires. For determining number of sessions needed for achieving clinically meaningful changes, scores of patients on VAS items (based on GPTS, EMA and ORS), and scores of therapists on the GCI will be compared per session between conditions.	—

Measure

Time frame

Mean scores before and after treatment on GPTS, SIAS, PSYRATS, SBQ, PSWQ, SERS, IPSM, BCSS and DACOBS will be compared between conditions. Cost-effectiveness analyses (CEA) will be conducted using TiC-P and EQ-5D-5L questionnaires. For determining number of sessions needed for achieving clinically meaningful changes, scores of patients on VAS items (based on GPTS, EMA and ORS), and scores of therapists on the GCI will be compared per session between conditions.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)