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

• Sponsor: Islamia University of Bahawalpur (Other)
• Overall Status: Completed
• CT.gov ID: NCT06123078
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site: 20
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life	Behavioral: CaCBT	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Repeated measures designRepeated measures design
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blind control technique
• Primary Purpose: Health Services Research
• Official Title: Impact of Schemas, Cognitive Emotion Regulation on Quality of Life of HIV Patients: Assessing Outcomes of CBT
• Actual Study Start Date: Jul 1, 2022
• Actual Primary Completion Date: Oct 1, 2022
• Actual Study Completion Date: Mar 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Social Connectedness Scale SCS-R [8 months]

   To measure social connectedness

2. WHOQOL-HIV Bref [8 months]

   HiV patients Quality of life will be enhanced

3. Schema Mode Inventory [8 months]

   This helped to measure schemas

4. CERQ [8 months]

   To measure cognitive emotion regulation strategies

5. WHOQOL [8 months]

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

Other Outcome Measures

1. Cognitive Behavioural therapy [4 months]

   CBT Intervention will be given to HIV patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nai Zindagi Trust	Rahim yar khan	Punjab	Pakistan	64200
2	Sheikh Zyed Hospital	Rahimyar Khan	Punjab	Pakistan	64200

Sponsors and Collaborators

• Islamia University of Bahawalpur

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rabia Javed Bhatti, Principal Investigator, Islamia University of Bahawalpur
• ClinicalTrials.gov Identifier: NCT06123078
• Other Study ID Numbers: 123987
• First Posted: Nov 8, 2023
• Last Update Posted: Nov 8, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 8, 2023