ENGAGE: Virtual Reality-based Psychotherapy for Negative Symptoms in Schizophrenia

Percentage of target sample (30 participants) recruited after 15 months from study start

Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (10 sessions)

Percentage of participants in the experimental group reporting a satisfaction rating of more than 7 on a 10-point Likert scale with higher scoring indicating a higher level of satisfaction with therapy.

The BNSS is a an interviewer-administered instrument comprising 13 items and five domains of negative symptoms: anhedonia, asociality, avolition, blunted effect and alogia.

Each item is rated on a 7-point scale (0-6) with higher scores reflecting a higher level of negative symptoms.

The SANS is an interviewer-administered instrument comprising 23 items and four domains of negative symptoms: affective flattening or blunting, alogia, avolition-apathy, and anhedonia-asociality.

Each item is rated on a 5-point scale (0-5) with higher scores reflecting a higher level of negative symptoms.

The SNS is a patient questionnaire comprising 20 items and 5 domains of negative symptoms: social withdrawal, diminished emotional range, alogia, avolition, and anhedonia.

Each item is rated on a 3-point scale (0-2) with higher scores reflecting higher levels of negative symptoms.

The PSP is an interviewer-administered instrument assessing different domains of social and daily functioning: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior.

A score between 1-100 is assigned with higher scores indicating better functioning.

The SFS is a self-report instrument assessing social functioning among individuals with schizophrenia.

The instrument comprises seven domains: Social engagement/withdrawal, Interpersonal behaviour, Prosocial activities, Recreation, Independence-competence, Independence-performance and Employment/occupation.

The minimum raw score is 0 and maximum raw score is 223 with higher scoring indicating a higher level of functioning.

The WHO-5 is a self-report questionnaire with 5 items measuring subjective psychological well-being. Each item is scored on a 6-point scale ranging At no time (0) to All of the time (5).

A total raw score is ranging from 0 to 25. To calculate the final score, the total raw score is multiplied by 4 with higher scores reflecting higher levels of well-being.

The CDSS is an interviewer-administered instrument comprising 9 items assessing level of depression among individuals with schizophrenia. Each item is rated on a 4-point scale ranging from Absent (0) to Severe (3) with higher scores indicating a higher level of depressive symptoms.

The ACIPS is a patient questionnaire comprising 17 items assessing hedonic capacity for social interaction and interpersonal engagement.

Each item is rated on a 6-point scale (1-6) with higher scores reflecting higher levels of hedonic capacity.

The DPAS is a self-report instrument comprising 15 items assessing defeatist performance beliefs.

Each item is rated on a 7-point scale (1-7) with higher scores reflecting stronger defeatist performance beliefs (range: 15-105).

SAPS is an interviewer-administered instrument with 34 items measuring severity of hallucinations, delusions, bizarre behavior and positive formal thought disorder.

Each item is rated on a 6-point scale (0-5) with higher scores reflecting higher levels of positive symptoms.

Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise).The outcome measures for ERT cover percentage and number correct or incorrect and overall response latencies, which can be looked at either across individual emotions or across all emotions at once.

RTQ is a 6-item self-report questionnaire measuring the participants positive attitude and preparedness to enter therapy for the purpose of resolving problems. Each item is scored on a 5-point Likert scale ranging from strongly disagree (0) to strongly agree (4). Item 2, 3 and 6 are reversed scored. A higher score indicates greater readiness for therapy.

CSQ is an 8 item self-report measuring client satisfaction with the intervention. All items are scored on a 4-point Likert scale ranging from bad (1) to excellent (4). Higher scores indicate higher satisfaction.

VRSSQ-MDV is a is a self-report questionnaire measuring virtual reality simulation sickness. The Modified Danish Version consists of 9 items rated on a 4-point Likert Scale ranging from 0 (not at all) to 3 (a lot). Higher scores reflect higher degree of virtual reality simulation sickness. The VRSSQ-MDV will be administered only to participants in the experimental group.

MPS-MSDV is a self-report questionnaire measuring presence in virtual reality. The modified, shortened Danish Version consists of 10 selected items scored on a 5-point Likert Scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Higher scores reflect higher degree of presence in Virtual Reality. The MPS-MSDV will be administered only to participants in the experimental group.

Brain activation during anticipation of monetary and social rewards will be examined using two functional paradigms, the Social Incentive Delay Task (SIDT) and the Monetary Incentive Delay Task (MIDT). Key regions of interest for the study include mesocorticolimbic and fronto-striatal circuits including ventral tegmental area, amygdala, hippocampus, striatum, nucleus accumbens, and prefrontal cortex. Additionally, resting state fMRI will be acquired.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints per day over a 7-day course. Using a purpose-designed questionnaire, positive affect will be measured on a 4-item visual analogue scale from 0 to 10 with higher values indicating greater positive affect.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints per day over a 7-day course. Using a purpose-designed questionnaire, negative affect will be measured on a 4-item visual analogue scale from 0 to 10 with higher values indicating greater negative affect.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints per day over a 7-day course. Using a purpose-designed questionnaire, consummatory and anticipatory hedonia in reaction to activities will be measured on a 2-item visual analogue scale from 0 to 10 with higher values indicating greater negative affect.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints (beeps) per day over a 7-day course. Using a purpose-designed questionnaire, the number of self-reported activities at each beep and the number of beeps without any activities will be recorded.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints (beeps) per day over a 7-day course. Using a purpose-designed questionnaire, the number of self-reported companions and the number of beeps in absence of company will be recorded.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints per day over a 7-day course. Using a purpose-designed questionnaire, asociality in reaction to being alone or in company will be measured on a 4-item visual analogue scale from 0 to 10 (of which two items are inversely coded) with higher values indicating greater asociality.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints per day over a 7-day course. Using a purpose-designed questionnaire, avolition will be measured on a 2-item visual analogue scale from 0 to 10 with lower values indicating greater levels of avolition.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints per day over a 7-day course. Time spent on sedentary behaviors will be calculated from accelerometry data recorded from participants' mobile phone sensors.

Ecological Momentary Assessment (EMA) will be employed capturing momentary features of negative symptoms at 5 randomly distributed timepoints per day over a 7-day course. As an objectively measurable feature of inactivity, time spent at home will be calculated from location data recorded from participants' mobile phone sensors.