- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07719998
A Psychoeducational Intervention for Reducing Psychological Distress and Caregiver Burnout Among Family Caregivers of Individuals With Bipolar Disorder
A Feasibility Evaluation of a Psychoeducational Intervention for Reducing Psychological Distress and Caregiver Burnout Among Family Caregivers of Individuals With Bipolar Disorder
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Bipolar Disorder is a chronic psychiatric condition characterized by recurrent episodes of mania, hypomania, and depression. Family caregivers play a central role in supporting individuals with Bipolar Disorder; however, prolonged caregiving responsibilities often result in increased psychological distress, emotional exhaustion, and caregiver burden. In Pakistan, limited structured psychoeducational programs are available to support family caregivers despite their significant role in patient care.
This study is a feasibility trial designed to examine the implementation and preliminary effectiveness of a structured psychoeducational intervention for family caregivers of individuals with Bipolar Disorder. The intervention consists of therapist-led sessions focusing on increasing caregivers' understanding of Bipolar Disorder, symptom recognition, treatment adherence, relapse prevention, communication skills, stress management, coping strategies, problem-solving, and self-care practices.
Primary outcomes include psychological distress and caregiver burden, measured using the Kessler Psychological Distress Scale (K10) and the Zarit Burden Interview (ZBI-22), respectively. Participants will complete these measures before the intervention and after completing the psychoeducational program. The study will evaluate the feasibility of recruitment, participant retention, intervention delivery, and participant acceptability, while also examining preliminary changes in caregiver psychological distress and burden following the intervention.
The findings are expected to contribute to the development of culturally appropriate caregiver support programs and provide evidence for integrating psychoeducational interventions into mental health services for families of individuals with Bipolar Disorder in Pakistan.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Punjab Province
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Guiranwala, Punjab Province, Pakistan, 50250
- DHQ Gujranwala
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
Primary family caregiver of an individual diagnosed with Bipolar Disorder by a qualified psychiatrist.
Aged between 25 and 40 years. Providing direct care to the patient for at least one year. Able to read, understand, and communicate in Urdu. Willing and able to provide written informed consent. Willing to participate in all psychoeducational intervention sessions and study assessments.
Exclusion Criteria:
Professional, paid, or temporary caregivers. Caregivers currently receiving structured psychotherapy or psychological intervention for psychological distress or caregiver burden.
Individuals with severe psychiatric disorders, cognitive impairment, or neurological conditions that may interfere with participation or completion of assessments.
Caregivers who are unable or unwilling to complete the intervention sessions or study questionnaires.
Caregivers who withdraw consent at any stage of the study.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Psychoeducational Intervention Group
Participants in this arm will receive a structured psychoeducational intervention designed for family caregivers of individuals with Bipolar Disorder.
The intervention includes education about Bipolar Disorder, symptom recognition, treatment adherence, relapse prevention, stress management, coping strategies, communication skills, problem-solving, and caregiver self-care.
Participants will complete outcome assessments at baseline and after completion of the intervention using the Kessler Psychological Distress Scale (K10) and the Zarit Burden Interview (ZBI-22).
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A structured psychoeducational intervention developed for family caregivers of individuals with Bipolar Disorder.
The intervention consists of therapist-led sessions focusing on understanding Bipolar Disorder, recognizing symptoms and relapse warning signs, treatment adherence, stress management, coping strategies, communication skills, problem-solving, caregiver self-care, and available support resources.
The intervention is designed to reduce psychological distress and caregiver burden while improving caregivers' knowledge, coping abilities, and confidence in managing caregiving responsibilities.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Caregiver Burden
Ramy czasowe: Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
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Caregiver burden will be assessed using the 22-item Zarit Burden Interview (ZBI-22).
Changes in caregiver burden scores will be evaluated between baseline (pre-intervention) and post-intervention.
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Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
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Psychological Distress
Ramy czasowe: Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
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Psychological distress will be assessed using the Kessler Psychological Distress Scale (K10).
Changes in participants' psychological distress scores will be compared between baseline (pre-intervention) and post-intervention.
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Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Dr Umi Lalia, Phd, GIFT University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- GIFT/PSY/MS/2025/012
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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