Caregiver Burden in Methamphetamine Use DisorderNCT07714642
Effectiveness of Stress Management Training Program For Expressed Emotions in Caregivers of Drug Induced Psychosis Patients Specially Methamphetamine
A study testing O'Connor's (2003) Stress Management Training in people with Caregiver Burden in Methamphetamine Use Disorder and Expressed Emotions in Caregivers, run by Government College University Faisalabad at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden in Methamphetamine Use Disorder, Expressed Emotions in Caregivers, Stress Cause Expressed Emotion and Burden
- What is being tested?
- O'Connor's (2003) Stress Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Mar 2026to 17 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Government college university Faislabad
Faisalabad, Punjab Province, 38000
About this study
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.
Read the detailed description
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.
- Conditions
- Caregiver Burden in Methamphetamine Use Disorder, Expressed Emotions in Caregivers, Stress Cause Expressed Emotion and Burden
- Being tested
- O'Connor's (2003) Stress Management Training
- Keywords
- Caregiver Stress, Methamphetamine induced psychosis, Stress Management Training, O'Connor intervention, Coping skills
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O'Connor's (2003) Stress Management TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Management Training Group (experimental group) | Experimental | 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. Receives: Behavioral: O'Connor's (2003) Stress Management Training |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start24 Mar 2026
- Primary completion24 Apr 2026
- Study completion17 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver Burden in Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the O'Connor Stress Management Training group or a waitlist control group."
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mah Noor, Government College University Faisalabad
- Investigators
- Dr. Asma Riaz, Principal investigator, Government college university Faislabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714642
- Sponsor's protocol ID
- Mah Noor
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to maintain participant confidentiality and protect privacy in accordance with ethical guidelines.
Publications
Zuanny, I. P., & Husna, M. (2023). Stress management intervention in caregivers of people with schizophrenia at Puskesmas X Yogyakarta. Psikoislamedia: Jurnal Psikologi, 8(2), 132-146.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Stress Management Training Program For Expressed Emotions in Caregivers of Drug Induced Psychosis Patients Specially Methamphetamine
- ClinicalTrials.gov ID
- NCT07714642
- Acronym / sponsor ID
- Mah Noor
- Conditions
- Caregiver Burden in Methamphetamine Use Disorder, Expressed Emotions in Caregivers, Stress Cause Expressed Emotion and Burden
- Keywords
- Caregiver Stress, Methamphetamine induced psychosis, Stress Management Training, O'Connor intervention, Coping skills
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 17 Aug 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the O'Connor Stress Management Training group or a waitlist control group."
| Arm | Type | Receives |
|---|---|---|
| Stress Management Training Group (experimental group) | Experimental | Behavioral: O'Connor's (2003) Stress Management TrainingParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O'Connor's (2003) Stress Management TrainingA 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. | Behavioural | Stress Management Training Group (experimental group) |
Primary outcome
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.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Results publicationZuanny, I. P., & Husna, M. (2023). Stress management intervention in caregivers of people with schizophrenia at Puskesmas X Yogyakarta. Psikoislamedia: Jurnal Psikologi, 8(2), 132-146.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to maintain participant confidentiality and protect privacy in accordance with ethical guidelines.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Asma Riaz principal investigator
Government college university Faislabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O'Connor's (2003) Stress Management Training in people with Caregiver Burden in Methamphetamine Use Disorder and Expressed Emotions in Caregivers, run by Government College University Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07714642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.