The primary goal of this pilot study is to examine the feasibility and acceptability of a new Virtual Reality-based intervention against negative symptoms in schizophrenia spectrum disorders (SSD). The main questions it aims to answer are: 1. Is Virtual Reality-based therapy a feasible and acceptable treatment for negative symptoms in SSD? 2. Are there indications that the treatment is effective in reducing negative symptoms, improving daily functioning, and enhancing quality of life? Researchers will compare the new Virtual Reality-based treatment to standard psychiatric care to evaluate therapy effectiveness. Participants will be allocated to receive either 10 sessions of Virtual Reality-based therapy or Treatment as usual. All participants will undergo a thorough assessment at baseline and at follow-up after 12 weeks.
Negative symptoms (NS) are core features of schizophrenia and strongly correlated with vocational and social outcomes, quality of life, and have a higher impact on later outcome than positive symptoms (PS) such as hallucinations and delusions. While there are good medical treatment options for PS, no robust and replicated evidence exists for effective NS treatments. Consistent evidence suggests that abnormalities of the brain reward system are central in the pathogenesis of NS, i.e., the domains of anhedonia and avolition. Preliminary evidence indicates changes in reward learning following therapy is related to a reduction in NS. Virtual reality (VR) is a promising technologically advanced mental health research tool with high ecological validity. VR allows individuals to immerse themselves in realistic environments and interact with virtual objects, providing a safe and controlled space to address symptoms and improve functioning. Initial evidence (N=4) supports that VR-based interventions significantly reduce NS and improve psychosocial functioning with a medium to large effect size. Given the suggested central role of reward processing disturbances in the pathogenesis of NS, there is an obvious need to investigate the effect of a VR-based intervention targeting reward processing in ameliorating NS. Both NS and motivational abnormalities reflect complex processes at a system level likely corresponding to functional brain activity within and between several regions and circuits. Supplementing the clinical assessments in the study with magnetic resonance imaging (MRI) data may clarify whether the intervention directly targeting reward processing has an effect on the biological processes/networks involved. In sum, this study will explore the prospects of using an innovative, VR-based treatment to treat NS and reward processing deficits in schizophrenia aimed at producing real-life benefits for the patients. If found successful, this pilot study could lay the foundation for a larger randomized clinical trial examining the intervention's effectiveness. Prospectively, these results can pave the way for a much sought-after treatment option for NS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
A manualized, modularized, Virtual Reality-based intervention comprising 10 sessions of 1 hour each. The VR therapy aims at enhancing anticipatory pleasure and positive emotions by amplifying exposure and reactivity towards social environments and rewarding activities using a highly elaborate VR software. The VR exposure comprises several different virtual social environments (e.g., a bus, a café, a park etc.) In a tailored treatment approach, therapists will guide participants to train focusing on positive stimuli, engage in activities, experience social rewards, and practice expressing emotions through body language. The therapy focuses on increasing the awareness of positive outcomes that may influence motivation. The therapy deploys activity appraisal/re-appraisal intended to enhance the salience of future opportunities for reward and desire for such rewards, thus targeting reward anticipation processes and promoting enjoyable daily-life activities.
Copenhagen Research Center for Mental Health (CORE), Mental Health Services CPH, Denmark
Hellerup, Greater Copenhagen, Denmark
Feasibility and acceptability as assessed by recruitment rate
Percentage of target sample (30 participants) recruited after 15 months from study start
Time frame: Recruitment rate is monitored throughout the study period (15 months)
Feasibility and acceptibility as assessed by retention rate
Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (10 sessions)
Time frame: Retention rates are monitored throughout the study period (15 months)
Feasibility and acceptability as assessed by level of satisfaction in the experimental group
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.
Time frame: At 12 weeks follow-up
Severity of negative symptoms as assessed by the Brief Negative Symptoms Scale (BNSS)
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.
Time frame: Baseline and at 12 weeks follow-up
Severity of negative symptoms as assessed by the Scale for the Assessment of Negative Symptoms (SANS)
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.
Time frame: Baseline and at 12 weeks follow-up
Severity of negative symptoms as assessed by the Self-evaluation of Negative Symptoms (SNS)
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.
Time frame: Baseline and at 12 weeks follow-up
Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)
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.
Time frame: Baseline and at 12 weeks follow-up
Social functioning as assessed by the Social Functioning Scale (SFS)
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.
Time frame: Baseline and at 12 weeks follow-up
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