- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Punjab Province
-
Faisalabad, Punjab Province, Pakistan, 38000
- Government college university Faislabad
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Stress Management Training Group (experimental group)
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.
|
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.
|
|
Nessun intervento: Control Group
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Burden Scale for Family Caregivers - Short Version (BSFC-s)
Lasso di tempo: 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.
|
Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program).
|
|
Perceived Stress Scale-10 (PSS-10)
Lasso di tempo: 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
|
Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)
|
|
Family Questionnaire (FQ)
Lasso di tempo: 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.
|
Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)
|
|
General Health Questionnaire-12 (GHQ-12)
Lasso di tempo: 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.
|
Baseline (pre-intervention) and post-intervention (immediately following the completion of the training program)
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Dr. Asma Riaz, Government college university Faislabad
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Mah Noor
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su O'Connor's (2003) Stress Management Training
-
Portland State UniversityOregon Department of Human Services; Oregon Social Learning CenterCompletato
-
ProPersonaNon ancora reclutamentoAnsia | Sintomi depressivi | Lesione cerebrale acquisita | Disfunzione esecutivaOlanda
-
Klimmendaal RevalidatiespecialistenReclutamentoLesione cerebrale acquisita | Disfunzione esecutiva | Formazione sulla gestione degli obiettivi | Formazione sulla strategia compensativa | Gioco serioOlanda
-
Fundació Sant Joan de DéuParente AIReclutamentoIrritabilità | Disturbo da deficit di attenzione con iperattività (ADHD) | Problema di comportamento dell'infanzia e dell'adolescenza | Comportamenti dirompenti | Formazione per la gestione dei genitori | Intelligenza Artificiale (AI)Spagna
-
Dr. Faizan AwanCompletatoCovid19 | Stress occupazionaleRegno Unito
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletatoDisturbo da dipendenza da Internet | Tecnologia digitale | Yoga della risata | Dipendenza dalla tecnologiaTurchia (Türkiye)
-
Mayo ClinicCompletatoQualità della vita | Chirurgia gastrointestinale complessaStati Uniti
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletatoFatica | Sintomi depressivi | Cancro del retto in stadio IIA | Cancro del retto in stadio IIB | Cancro del retto in stadio IIC | Cancro del retto in stadio IIIA | Cancro del retto in stadio IIIB | Cancro del retto in stadio IIIC | Effetti psicosociali del cancro e del suo trattamento | Cancro al colon in... e altre condizioniStati Uniti