NCT06123078

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

October 14, 2023

Last Update Submit

November 6, 2023

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (5)

  • Social Connectedness Scale SCS-R

    To measure social connectedness

    8 months

  • WHOQOL-HIV Bref

    HiV patients Quality of life will be enhanced

    8 months

  • Schema Mode Inventory

    This helped to measure schemas

    8 months

  • CERQ

    To measure cognitive emotion regulation strategies

    8 months

  • WHOQOL

    After intervention on HIV patients, Quality of Life will be enhanced as an outcome of the CBT intervention

    8 months

Other Outcomes (1)

  • Cognitive Behavioural therapy

    4 months

Study Arms (2)

Control group

NO INTERVENTION

treatment as usual

Experimental group

EXPERIMENTAL

CaCBT

Behavioral: CaCBT

Interventions

CaCBTBEHAVIORAL

Culturally adapted Self help guide and modules total eight 80 hour session per week

Experimental group

Eligibility Criteria

Age20 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nai Zindagi Trust

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

Sheikh Zyed Hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

Study Officials

  • Rabia J Bhatti, PhD

    The Islamia University of Bhawalpur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind control technique
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Repeated measures design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2023

First Posted

November 8, 2023

Study Start

July 1, 2022

Primary Completion

October 1, 2022

Study Completion

March 30, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Data is sensitive, can assess directly by the principle investigator

Locations

PA(2)