An interventional study of O'Connor's (2003) Stress Management Training in Caregiver Burden in Methamphetamine Use Disorder, Expressed Emotions in Caregivers and Stress Cause Expressed Emotion and Burden, sponsored by Government College University Faisalabad. Active, not recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Government College University Faisalabad · Not applicable, Interventional, and Supportive care
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.
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.
422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.
This study's enrollment of 30 is below the median of 73 across 330 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →Government College University Faisalabad is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
-
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.
Participants in this arm will receive the O'Connor Stress Management Training program. The intervention consists of structured sessions focusing on stress education, cognitive restructuring, coping mechanisms, and relaxation techniques.
Behavioral: O'Connor's (2003) Stress Management Training
Participants in this arm will not receive the active training during the primary study period. They will complete the pre and post-intervention assessments at the same time intervals as the experimental group.
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.
Burden Scale for Family Caregivers - Short Version (BSFC-s)
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.
Time frame: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program).
Perceived Stress Scale-10 (PSS-10)
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
Time frame: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)
Family Questionnaire (FQ)
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.
Time frame: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)
General Health Questionnaire-12 (GHQ-12)
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.
Time frame: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)
Plan to share: No — Individual participant data will not be shared publicly to maintain participant confidentiality and protect privacy in accordance with ethical guidelines.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Government College University Faisalabad