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Active, Not Recruiting

NCT Number: NCT07714642

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Caregiver Burden in Methamphetamine Use Disorder Behavior Behavioral Symptoms Caregiver Burden Expressed Emotions in Caregivers Stress Cause Expressed Emotion and Burden Stress, Psychological

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Government college university Faislabad

Faisalabad, Punjab Province, 38000, Pakistan

About this study

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.

Key Intervention Components:

Psychoeducation regarding caregiver stress and the cycle of addiction. Cognitive restructuring and identifying negative cognitive distortions. Practical coping skills, emotional regulation strategies, and problem-solving techniques.

Guided progressive muscle relaxation (PMR) and mindfulness-based breathing exercises.

Outcome Measures and Data Collection Data collection will occur at two primary intervals: baseline (pre-intervention) and post-intervention (immediately following the final training session). The primary outcome measure for assessing perceived psychological distress will be the standardized Perceived Stress Scale-10 (PSS-10), utilized in its validated Urdu version to ensure linguistic and cultural appropriateness for the target population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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Exclusion criteria

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.

Treatment and study plan

O'Connor's (2003) Stress Management Training

Behavioral

A 3-session, group-based stress management program. Session 1 focuses on recognizing stress and its signs, introducing abdominal breathing relaxation techniques. Session 2 covers coping strategies, cognitive reframing, and relaxation. Session 3 focuses on practicing coping in groups, guided imagery, and gratitude-based emotion stabilization. Each session lasts 45 minutes, administered weekly.

Primary outcomes

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

    Time frame: 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.

  2. Perceived Stress Scale-10 (PSS-10)

    Time frame: 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

  3. Family Questionnaire (FQ)

    Time frame: 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.

  4. General Health Questionnaire-12 (GHQ-12)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Government College University Faisalabad

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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