A Psychoeducational Intervention for Reducing Psychological Distress and Caregiver Burnout Among Family Caregivers of Individuals With Bipolar Disorder

NCT07719998 | Active Not Recruiting DMC

• 1 other identifier: GIFT/PSY/MS/2025/012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder.Psychological Distress Caregiver Burden; Bipolar Disorder. Psychological Distress. Caregiver Burden

Outcome Measures

Primary Outcomes (2)

• Caregiver Burden

  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.

  Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).

• Psychological Distress

  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.

  Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).

Study Arms (1)

Psychoeducational Intervention Group

EXPERIMENTAL

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).

Behavioral: Psychoeducational Intervention

Interventions

Psychoeducational Intervention BEHAVIORAL

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.

Psychoeducational Intervention Group

Eligibility Criteria

• Age: 24 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GIFT University: lead

Study Sites (1)

DHQ Gujranwala

Guiranwala, Punjab Province, 50250, Pakistan

Location

Study Officials

• Dr Umi Lalia, Phd

  GIFT University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-group pre-test/post-test feasibility study evaluating the feasibility and preliminary effectiveness of a structured psychoeducational intervention for family caregivers of individuals with Bipolar Disorder.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: May 20, 2026
• Primary Completion: July 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)