Ignite Creation Date:
2024-05-06 @ 1:11 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01752712
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2012-12-14
Brief Title:
Oxytocin and CBSST for People With Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Combined Oxytocin and CBSST for Social Function in People With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others which may reflect social aversion secondary to defeatist beliefs decreased motivation for social interactions andor impairment in the normal reinforcement value of social interactions These impairments in social function have been shown to be associated with social skill deficits and decreased ability to identify and remember emotional facial expressions and empathize with the emotional status of others Unfortunately pharmacological interventions have limited benefits for impaired social function whereas psychosocial interventions provide only partial benefit for this critical aspect of the illness The development of an effective intervention for functional outcomes remains a central therapeutic challenge Cognitive Behavioral Social Skills Training CBSST uses corrective feedback and reinforcement provided by successful interactions to challenge and reduce defeatist performance beliefs that contribute to low drive and interfere with social functioning CBSST has been shown to have modest effects on social function in people with schizophrenia Oxytocin plays a critical role in the regulation of normal social affiliative behavior it is hypothesized to enhance social affiliation through the reduction of anxiety or social risk aversion the enhancement of motivation for prosocial approach behavior andor increased modulation of the salience and processing of social cues People with schizophrenia have decreased oxytocin levels which are associated with an impaired ability to identify facial emotions and decreased prosocial behaviors The study will be comprised of three phases 1 2-week Evaluation Phase 2 24-week Double-blind Treatment Phase and 3 3-month Follow-up Phase
Detailed Description:
A NIMH mission priority is the development of new and better interventions whose focus extends beyond symptom amelioration to the development of interventions that allow people who suffer from severe mental illnesses to live full and productive lives NIMH Strategic Plan 2008 In particular the NIMH Strategic Plan notes the importance of translating research on the biological causes of disorder to inform and develop psychosocial and biomedical interventions that target core features of disease assess outcomes appropriate to the course of illness under study and develop study designs that have impact on these features The current proposal is built upon the observations that 1 people with schizophrenia are characterized by marked impairments in their social function 2 current pharmacological treatments do not address these impairments 3 CBSST has been shown to have modest effects on social function in people with schizophrenia This limited efficacy may be related to the lack of interest or drive people with schizophrenia have for social interactions 4 oxytocin plays a critical role in normal social affiliative behavior through a the reduction of anxiety or social risk aversion b the enhancement of motivation for prosocial approach or affiliative behavior andor c increased modulation of the salience and processing of social cues and 5 decreased oxytocin is associated with social function impairments in people with schizophrenia
The proposed study is based on the proposition that the use of a pharmacological agent whose behavioral effects compliment the psychological mechanisms of action of a psychosocial intervention is an important adaptation of an intervention previously shown to have moderate effects on social function The addition of oxytocin to CBSST is hypothesized to 1 enhance the reduction of defeatist performance beliefs by reducing social risk aversiveness and avoidance which would increase exposure to reinforcement and corrective feedback 2 enhance social skill acquisition through improvement of proximal social behaviors eg making eye contact and attending to the facial expressions of social partners and 3 facilitate the translation of learned social skills into community practice through its effects on prosocial attachment behaviors reduction in social disinterest and effects on distal behaviors eg initiating conversations and responding to social invitations Increased social risk taking within and between sessions would expose participants to a greater frequency of positive feedback and success experiences which would provide evidence to dispute their defeatist beliefs and social disinterest attitudes In addition increased social risk taking could improve homework adherence eg practicing talking to people in the community and engagement in new community activities These interactive effects would subsequently lead to a substantial improvement in CBSST efficacy for social function Ultimately the importance of improved social function is the effect that such improvement would have on overall levels of health and functioning including vocational outcome
The proposed study will enable us to collect preliminary data on the acceptability efficacy feasibility and safety of the proposed intervention In particular this would be the first study to examine the safety of long-term oxytocin in this population The study will also provide critical data on the feasibility of recruiting and retaining participants with schizophrenia in a long-term intervention which combines two different therapeutic modalities CBSST and oxytocin If found to be efficacious feasible and well-tolerated we will plan to conduct a larger study which would include the use of cognitive and imaging biomarkers to more fully elucidate the mechanism of action of the observed treatment effects The investigators will address the following specific aims
Aim 1 Efficacy To determine if CBSST oxytocin compared to CBSST placebo-oxytocin is associated with improved social function
Aim 2 Safety To determine if CBSST oxytocin compared to CBSST placebo-oxytocin is associated with increased incidence of side effects
Aim 3 Change Mechanism To determine if CBSST oxytocin compared to CBSST placebo-oxytocin is associated with reduced social aversion including social disinterest and defeatist performance beliefs increased ability to trust others andor improved performance on facial recognition and memory measures
Aim 4 Other Outcomes To determine if CBSST oxytocin compared to CBSST placebo-oxytocin is associated with improved neuropsychological test performance andor decreased positive negative andor anxietydepression symptoms and clinical global improvement
The proposed study is based on the proposition that the use of a pharmacological agent whose behavioral effects compliment the psychological mechanisms of action of a psychosocial intervention is an important adaptation of an intervention previously shown to have moderate effects on social function The addition of oxytocin to CBSST is hypothesized to 1 enhance the reduction of defeatist performance beliefs by reducing social risk aversiveness and avoidance which would increase exposure to reinforcement and corrective feedback 2 enhance social skill acquisition through improvement of proximal social behaviors eg making eye contact and attending to the facial expressions of social partners and 3 facilitate the translation of learned social skills into community practice through its effects on prosocial attachment behaviors reduction in social disinterest and effects on distal behaviors eg initiating conversations and responding to social invitations Increased social risk taking within and between sessions would expose participants to a greater frequency of positive feedback and success experiences which would provide evidence to dispute their defeatist beliefs and social disinterest attitudes In addition increased social risk taking could improve homework adherence eg practicing talking to people in the community and engagement in new community activities These interactive effects would subsequently lead to a substantial improvement in CBSST efficacy for social function Ultimately the importance of improved social function is the effect that such improvement would have on overall levels of health and functioning including vocational outcome
The proposed study will enable us to collect preliminary data on the acceptability efficacy feasibility and safety of the proposed intervention In particular this would be the first study to examine the safety of long-term oxytocin in this population The study will also provide critical data on the feasibility of recruiting and retaining participants with schizophrenia in a long-term intervention which combines two different therapeutic modalities CBSST and oxytocin If found to be efficacious feasible and well-tolerated we will plan to conduct a larger study which would include the use of cognitive and imaging biomarkers to more fully elucidate the mechanism of action of the observed treatment effects The investigators will address the following specific aims
Aim 1 Efficacy To determine if CBSST oxytocin compared to CBSST placebo-oxytocin is associated with improved social function
Aim 2 Safety To determine if CBSST oxytocin compared to CBSST placebo-oxytocin is associated with increased incidence of side effects
Aim 3 Change Mechanism To determine if CBSST oxytocin compared to CBSST placebo-oxytocin is associated with reduced social aversion including social disinterest and defeatist performance beliefs increased ability to trust others andor improved performance on facial recognition and memory measures
Aim 4 Other Outcomes To determine if CBSST oxytocin compared to CBSST placebo-oxytocin is associated with improved neuropsychological test performance andor decreased positive negative andor anxietydepression symptoms and clinical global improvement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None