Quality of LifeStep-IINCT06123078
Impact of Schemas, Cognitive Emotion Regulation on Quality of Life of HIV Patients: Assessing Outcomes of CBT
A study testing CaCBT in people with Quality of Life, run by Islamia University of Bahawalpur at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Quality of Life
- What is being tested?
- CaCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Registered at ART clinics South Punjab region HIV Patients Stage 1 or stage 2 Understands urdu Age above 20
Who cannot join
- AIDS converted No Other terminal illness No other diagnosis Below 20 age
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Nai Zindagi Trust
Rahim Yar Khan, Punjab Province, 64200
Sheikh Zyed Hospital
Rahim Yar Khan, Punjab Province, 64200
About this study
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.
Read the 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
- Conditions
- Quality of Life
- Being tested
- CaCBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaCBTBehavioural
Culturally adapted Self help guide and modules total eight 80 hour session per week
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | treatment as usual |
| Experimental group | Experimental | CaCBT Receives: Behavioral: CaCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Connectedness Scale SCS-R
To measure social connectedness
Measured: 8 months
WHOQOL-HIV Bref
HiV patients Quality of life will be enhanced
Measured: 8 months
Schema Mode Inventory
This helped to measure schemas
Measured: 8 months
CERQ
To measure cognitive emotion regulation strategies
Measured: 8 months
WHOQOL
After intervention on HIV patients, Quality of Life will be enhanced as an outcome of the CBT intervention
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Jul 2022
- Primary completion1 Oct 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated measures design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Javed Bhatti, Islamia University of Bahawalpur
- Investigators
- Rabia J Bhatti, PhD, Principal investigator, The Islamia University of Bhawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123078
- Sponsor's protocol ID
- 123987
- Acronym
- Step-II
- Status last verified
- Nov 2023
- First submitted
- 14 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is sensitive, can assess directly by the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Schemas, Cognitive Emotion Regulation on Quality of Life of HIV Patients: Assessing Outcomes of CBT
- ClinicalTrials.gov ID
- NCT06123078
- Acronym / sponsor ID
- Step-II / 123987
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –treatment as usual |
| Experimental group | Experimental | Behavioral: CaCBTCaCBT |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Registered at ART clinics South Punjab region HIV Patients Stage 1 or stage 2 Understands urdu Age above 20
Key exclusion criteria (1 listed)
- AIDS converted No Other terminal illness No other diagnosis Below 20 age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaCBTCulturally adapted Self help guide and modules total eight 80 hour session per week | Behavioural | Experimental group |
Primary outcome
Social Connectedness Scale SCS-R
Time frame: 8 months
To measure social connectedness
WHOQOL-HIV Bref
Time frame: 8 months
HiV patients Quality of life will be enhanced
Schema Mode Inventory
Time frame: 8 months
This helped to measure schemas
CERQ
Time frame: 8 months
To measure cognitive emotion regulation strategies
WHOQOL
Time frame: 8 months
After intervention on HIV patients, Quality of Life will be enhanced as an outcome of the CBT intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No. Data is sensitive, can assess directly by the principle investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia J Bhatti, PhD principal investigator
The Islamia University of Bhawalpur
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaCBT in people with Quality of Life, run by Islamia University of Bahawalpur at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Connectedness Scale SCS-R (time frame: 8 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.