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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23574

Enrollment

106

Registered

2019-05-23

Start date

2019-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Virtual Reality, Schizophrenia, Psychosis, Cognitive Behavioral Therapy, Exposure Therapy Virtual Reality, Schizofrenie, Psychose, Cognitieve Gedragstherapie, Exposure Therapie

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 sessions

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - IQ under 70 - Insufficient command of Dutch language

Design outcomes

Primary

Measure	Time frame
Primary outcome is level of paranoid ideations in daily life social situations, measured with ecological momentary assessments (EMA). EMA is a structured diary method in which individuals are asked in normal daily life to report their momentary thoughts, feelings and symptoms, as well as the (appraisal of the) social context.	—

Secondary

Measure	Time frame
Secondary outcomes include EMA level of social activities, proportion of time spent in social company, levels of distress, anxiety and depression. Also, questionnaires and interview measures are used to assess paranoid thoughts and paranoid delusions, hallucinations, social anxiety, depressive symptoms, safety behaviors, worry, self-esteem, interpersonal sensitivity, cognitive schemas and cognitive biases. TiC-P and EQ-5D-5L measures are used to calculate cost-effectiveness and cost-utility. In order to test differences between VRcbt and CBT in number of sessions needed to achieve clinically meaningful change, participants will complete short questionnaires on level of paranoid ideation before each session and therapists will rate participants' level of paranoid ideation after each session.	—

Measure

Time frame

Secondary outcomes include EMA level of social activities, proportion of time spent in social company, levels of distress, anxiety and depression. Also, questionnaires and interview measures are used to assess paranoid thoughts and paranoid delusions, hallucinations, social anxiety, depressive symptoms, safety behaviors, worry, self-esteem, interpersonal sensitivity, cognitive schemas and cognitive biases. TiC-P and EQ-5D-5L measures are used to calculate cost-effectiveness and cost-utility. In order to test differences between VRcbt and CBT in number of sessions needed to achieve clinically meaningful change, participants will complete short questionnaires on level of paranoid ideation before each session and therapists will rate participants' level of paranoid ideation after each session.

—

Contacts

Public ContactW.A. Veling

Universitair Medisch Centrum Groningen

w.veling@umcg.nl0503612132

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)