跳至主要内容
临床试验/CTRI/2025/03/082627
CTRI/2025/03/082627尚未招募不适用

Evaluating the efficacy of a computer application vs. group therapy in managing expressed emotion in caretakers of chronic psychiatric patients- a Randomized Controlled Trial

Saveetha Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月10日最近更新:

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
Reduction in expressed emotion (EE) levels among caregivers, measured using the Family Attitude Scale (FAS). Assessments will be conducted at baseline, post-intervention (8 weeks).

研究概览

简要总结

The intervention consists of a comprehensive computer application designed to manage expressed emotions in caretakers of chronic psychiatric patients. It includes modules for psychoeducation, communication skills, emotion regulation, cognitive restructuring, problem-solving, expressed emotion awareness, mindfulness, role-playing, journaling, a resource library, and progress tracking. Family Attitude Scale is used as a questionnaire, it’s a validated measure commonly used to assess family dynamics and attitudes in mental health research. The scale typically includes items related to family cohesion, flexibility, communication patterns, emotional expression, problem-solving abilities, and overall family functioning. Participants rate their agreement or disagreement with each item on a Likert scale, allowing researchers to quantitatively evaluate family attitudes and dynamics. The intervention is compared with traditional group therapy in a Randomized Controlled Trial (RCT) to evaluate its efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Primary caregivers aged 18-65 years.
  • Must be the primary caregiver for a patient with a chronic psychiatric illness (e.g., schizophrenia, bipolar affective disorder, alcohol dependence syndrome).
  • At least 6 months of caregiving experience.
  • Ability to read and understand the language used in the computer application and group therapy sessions.
  • Access to a smartphone, tablet, or computer with internet connectivity for participants in the computer application group.

排除标准

  • Diagnosed psychiatric disorders in the caregiver that require immediate treatment.
  • Caregivers currently enrolled in similar psychoeducation or therapy programs.
  • Individuals with a history of poor adherence to structured interventions.
  • Conditions that may impair participation in either intervention (e.g., terminal illness, severe mobility issues).

结局指标

主要结局

Reduction in expressed emotion (EE) levels among caregivers, measured using the Family Attitude Scale (FAS). Assessments will be conducted at baseline, post-intervention (8 weeks).

时间窗: At baseline, 8 weeks and 12 weeks

次要结局

  • Secondary outcomes include caregiver burden, quality of life (QoL), adherence.(Assessments will be conducted at baseline, post-intervention (8 weeks).)

研究者

发起方
Saveetha Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Jumana Haseen S

Saveetha Medical College and Hospital

研究点 (1)

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