跳至主要内容
临床试验/NCT07714642
NCT07714642进行中(未招募)不适用

Effectiveness of Stress Management Training Program For Expressed Emotions in Caregivers of Drug Induced Psychosis Patients Specially Methamphetamine

Government College University Faisalabad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Burden Scale for Family Caregivers - Short Version (BSFC-s)

研究概览

简要总结

The main purpose of this study is to evaluate the effectiveness of a Stress Management Training (SMT) program in reducing stress levels among caregivers of individuals suffering from methamphetamine ("ice") addiction and methamphetamine-induced psychosis. Caregivers of patients with severe substance use disorders often experience high levels of chronic emotional, psychological, and physical stress, which can lead to severe burnout.

Participants in this study will be randomly assigned to either an active intervention group or a control group. The intervention group will participate in structured, multi-session stress management training sessions. The training program focuses on equipping caregivers with practical coping strategies, cognitive restructuring techniques, and relaxation skills based on established stress management modules.

Caregiver stress levels will be measured and compared before and after the training program using a standardized assessment tool to determine if the intervention successfully reduces psychological distress.

详细描述

Background and Rationale Caring for individuals with methamphetamine ("ice") addiction specially those who experience methamphetamine induced psychosis places an extraordinary psychological and emotional burden on family caregivers. Except the high prevalence of caregiver burnout and chronic distress in this population, accessible psychological support remains limited. This study aims to address this gap by evaluating a O'Connor model of Stress Management Training (SMT) to support caregivers who face geographic, financial, or logistical barriers to receiving in-person psychological services.

Study Objectives The primary objective of this experimental study is to investigate the efficacy of a Stress Management Training module in reducing perceived stress and improving coping mechanisms among caregivers of patients with methamphetamine addiction.

Methodology & Intervention Protocol Research Design: This is an experimental, randomized pre-test/post-test control group design.

Intervention Program: The active treatment group will undergo a structured Stress Management Training program adapted from the O'Connor Stress Management Training module. The training sessions will be delivered physically at Allied 2 hospital Faislabad.

Control Group: Participants in the control group will be placed on a wait list and will be offered the stress management training program upon the completion of the active study period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Caregivers of patients aged 18 to 65 years. Must have been actively providing care to the patient for at least the last three months.
  • Must possess the ability to understand and respond to the study questionnaires. Agree to take part in the study and provide informed consent. Must be directly responsible for the daily care of the patient.

排除标准

  • Giving care to the patient for less than three months. Caregivers of patients who live entirely alone (since direct caregiving interactions are required).
  • Caregivers who decline or refuse to participate in the study.

结局指标

主要结局

Burden Scale for Family Caregivers - Short Version (BSFC-s)

时间窗: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program).

The Burden Scale for Family Caregivers - Short Version (BSFC-s) is a 10-item self-report questionnaire used to assess the subjective burden experienced by family caregivers of individuals with substance use disorders. Each item is rated on a 4-point Likert scale: Strongly Agree (3), Agree (2), Disagree (1), and Strongly Disagree (0). Total scores range from 0 to 30, with higher scores indicating a more severe subjective caregiver burden. A score of 0-4 indicates no increased risk of physical complaints ; 5-14 indicates an increased risk of physical complaints; and 15-30 indicates a greatly increased risk of physical complaints. The study utilizes the validated Urdu version.

Perceived Stress Scale-10 (PSS-10)

时间窗: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)

A 10 item self-report questionnaire used to measure the degree to which situations in life are appraised as stressful by caregivers. Items are rated on a 5-point Likert scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress. The Urdu version of the scale will be utilized

Family Questionnaire (FQ)

时间窗: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)

The Family Questionnaire (FQ) is a 20-item self-report scale designed to assess the level of Expressed Emotion (EE) among caregivers, specifically focusing on two core domains: Critical Comments (CC; 10 items) and Emotional Over-Involvement (EOI; 10 items). Each item is scored on a 4-point Likert scale ranging from 1 (never/very rarely) to 4 (very often). Total scores range from 20 to 80, with higher scores indicating a higher level of expressed emotion, criticism, and emotional over-involvement toward the patient.

General Health Questionnaire-12 (GHQ-12)

时间窗: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)

A 12 item self-administered screening tool used to evaluate overall psychological distress and general mental health. Each item is rated on a 4-point scale. Using the Likert scoring method (0-1-2-3), the total score ranges from 0 to 36, with higher scores indicating worse psychological distress and lower general health status. The validated Urdu version of the scale is utilized in this study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mah Noor

MS Clinical Psychology scholar

Government College University Faisalabad

研究点 (1)

Loading locations...

相似试验