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

July 18, 2026 updated by: Maryam Asif, GIFT University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Guiranwala, Punjab Province, Pakistan, 50250
        • DHQ Gujranwala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: Psychoeducational Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Burden
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.
Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
Psychological Distress
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.
Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GIFT University

Investigators

  • Study Chair: Dr Umi Lalia, Phd, GIFT University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 18, 2026

First Submitted That Met QC Criteria

July 18, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 18, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GIFT/PSY/MS/2025/012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy in accordance with the approved research ethics protocol and institutional ethical guidelines. Only de-identified, aggregated study findings will be reported in publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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