Impact of Schemas, Cognitive Emotion Regulation on Qualit... | NCT06123078

Studies
Impact of Schemas, Cognitive Emotion Regulation on Quality of Life of HIV Patients: Assessing Outcomes of CBT

NCT06123078

Sponsor

Islamia University of Bahawalpur

Status

Completed

Last Update Posted

Nov 8, 2023Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Quality of Life

Interventions

CaCBT

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Mar 30, 2023Actual

First Submitted Date

Oct 14, 2023

First Submission Date that Met QC Criteria

Nov 6, 2023

First Posted Date

Nov 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2023

Last Update Posted Date

Nov 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rabia Javed Bhatti, Principal Investigator, Islamia University of BahawalpurPrincipal Investigator

Lead Sponsor

Islamia University of BahawalpurOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	No Intervention	treatment as usual
Experimental group	Experimental	CaCBT	Behavioral: CaCBT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CaCBT	Behavioral	Culturally adapted Self help guide and modules total eight 80 hour session per week	Experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rabia J Bhatti, PhD	The Islamia University of Bhawalpur	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nai Zindagi Trust		Rahim Yar Khan	Punjab Province	64200	Pakistan
Sheikh Zyed Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Data is sensitive, can assess directly by the principle investigator

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided