Impact of Schemas, Cognitive Emotion Regulation on Quality of Life of HIV Patients: Assessing Outcomes of CBT (Step-II)

November 6, 2023 updated by: Rabia Javed Bhatti, Islamia University of Bahawalpur
The present study has investigated the impact of schemas, cognitive emotion regulation and social connectedness on the Quality of life of HIV patients in South Punjab region, Pakistan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study has investigated the impact of schemas, cognitive emotion regulation and social connectedness on the Quality of life of HIV patients in South Punjab region, Pakistan. The main study was conducted in four steps as follows:

Step 1: Pre-testing, N=150 Baseline assessment Random assignment of willing participants to control and experimental Step 2: CBT Intervention, N=40, 20 each group Step 3: post-test Step 4: Follow up Assessmen

Study Type

Interventional

Enrollment (Actual)

40

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
      • Rahim yar khan, Punjab, Pakistan, 64200
        • Nai Zindagi Trust
      • Rahimyar Khan, Punjab, Pakistan, 64200
        • Sheikh Zyed Hospital

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:

- Registered at ART clinics South Punjab region HIV Patients Stage 1 or stage 2 Understands urdu Age above 20

Exclusion Criteria:

AIDS converted No Other terminal illness No other diagnosis Below 20 age

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
treatment as usual
Experimental: Experimental group
CaCBT
Behavioral: CaCBT
Culturally adapted Self help guide and modules total eight 80 hour session per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Connectedness Scale SCS-R
Time Frame: 8 months
To measure social connectedness
8 months
WHOQOL-HIV Bref
Time Frame: 8 months
HiV patients Quality of life will be enhanced
8 months
Schema Mode Inventory
Time Frame: 8 months
This helped to measure schemas
8 months
CERQ
Time Frame: 8 months
To measure cognitive emotion regulation strategies
8 months
WHOQOL
Time Frame: 8 months
After intervention on HIV patients, Quality of Life will be enhanced as an outcome of the CBT intervention
8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Behavioural therapy
Time Frame: 4 months
CBT Intervention will be given to HIV patients
4 months

Collaborators and Investigators

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

Sponsor

Islamia University of Bahawalpur

Investigators

  • Principal Investigator: Rabia J Bhatti, PhD, The Islamia University of Bhawalpur

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)

July 1, 2022

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 123987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is sensitive, can assess directly by the principle investigator

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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