A study to develop and assess the effect of Single Session Psychoeducation Based Intervention (SSPBI) on Affiliate stigma among caregivers of people with severe mental illnesses: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Change in Affiliate Stigma Scores measured by Affiliate Stigma Scale (ASS) within 48 hours after intervention.
研究概览
简要总结
“The term stigma connotes a deep mark of shame and degradation carried by a person as a function of being a member of a devalued social group.â€When the caregiver is affected by the prevailing public stigma, also understood as self‑stigma in caregivers of people with mental illness. Caregivers are involved in treatment related decisions for patient. Affiliate-stigma is important for treatment non-adherence, poorer course and outcome of the illness, poor quality of life, low self esteem and many more. So, there is a Need to understand the extent of caregivers’ affiliate-stigma and its correlates and to target with appropriate intervention. A Number of psychoeducative interventions are available, mostly lengthy, time consuming, require direct contact, demand a lot of professional expertise and experience, are situation specific (particular setting), have differential effectiveness and are illness specific. SSPBI will be short i.e. single session, feasible (easy to administer by any mental health professional) and applicable across different settings (like outpatient, inpatient, telemedicine, etc.) and through different modalities (one-to-one counselling, telephonically / remote application, multimedia assisted, etc.)
Study is divided into two phases:
PHASE I: Development of SSPBI : A draft of SSPBI will be prepared after reviewing the literature on effective measures to reduce stigma which would then be sent for approval by a review committee consisting of Psychiatrists/ Psychologists/ Social Workers. After making necessary suggested changes, a Pilot study for SSPBI will be done. A final SSPBI would be prepared.
PHASE II: Application of SSPBI and Evaluating it’s effect on affiliate stigma : SSPBI would then be applied to intervention group caregivers of people with severe mental illnesses after computerised randomisation via direct contact (OPD) and distance contact (telephonically/ video call) and changes in Affiliate stigma scores would be assessed immediately (within 48 hours ) and after 3 weeks of intervention and compared to the baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary Caregivers within the age group of 18-60 years
- •Caregivers of people who are suffering from SMI (as per ICD 10) for >3 months (and not more than 5 years).
- •Those consenting to participate in the study.
排除标准
- •Caregivers of patients with age <18 year or >60 years
- •People who do not give consent.
- •Caregivers’ self-report of any significant psychiatric disorder at present or in the past.
- •Caregivers’ or Patients’ self-report of significant substance use in patterns of harmful use/ dependant at present or in the past.
- •Caregivers’ or Patients’ self report of significant and visible physical disability at present or in the past.
- •Does not understand English / Hindi language.
结局指标
主要结局
1) Change in Affiliate Stigma Scores measured by Affiliate Stigma Scale (ASS) within 48 hours after intervention.
时间窗: Measurement will be done at 3 points: | 1) At baseline on day 1 before conducting SSPBI session | 2) Within 48 hours of application of SSPBI Session | 3) 3 weeks after the application of SSPBI session
2) Difference in reduction in affiliate stigma across 2 groups : direct contact and distance contact groups
时间窗: Measurement will be done at 3 points: | 1) At baseline on day 1 before conducting SSPBI session | 2) Within 48 hours of application of SSPBI Session | 3) 3 weeks after the application of SSPBI session
3) Difference in reduction in affiliate stigma across intervention groups and control groups.
时间窗: Measurement will be done at 3 points: | 1) At baseline on day 1 before conducting SSPBI session | 2) Within 48 hours of application of SSPBI Session | 3) 3 weeks after the application of SSPBI session
次要结局
- 1) Levels of affiliate stigma among caregivers of patients who are suffering with SMI(2) level of affiliate stigma 3 weeks after intervention)