DHQ Gujranwala
Guiranwala, Punjab Province, 50250, Pakistan
NCT Number: NCT07719998
This study aims to evaluate the feasibility and preliminary effectiveness of a structured psychoeducational intervention designed for family caregivers of individuals diagnosed with Bipolar Disorder. Family caregivers often experience high levels of psychological distress and caregiver burden due to the long-term demands of caregiving. The intervention is intended to improve caregivers' knowledge about Bipolar Disorder, enhance coping skills, promote self-care, and strengthen strategies for managing caregiving challenges. Psychological distress and caregiver burden will be assessed before and after the intervention using the Kessler Psychological Distress Scale (K10) and the Zarit Burden Interview (ZBI-22). The findings will help determine whether this intervention is feasible and beneficial for caregivers in the Pakistani context.
This study is active but is not currently recruiting participants.
Notify Me24 year–50 year
All sexes
Interventional
Not applicable
Guiranwala, Punjab Province, 50250, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
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.
Time frame: Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
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.
GIFT University
Other
A Feasibility Evaluation of a Psychoeducational Intervention for Reducing Psychological Distress and Caregiver Burnout Among Family Caregivers of Individuals With Bipolar Disorder
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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.