- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644383
Meaning of Life in HIV-infected Youths
August 17, 2016 updated by: The HIV Netherlands Australia Thailand Research Collaboration
Meaning in Life of Youth Infected With HIV
Logotherapy has never been evaluated in HIV-infected teenagers.
In this study, we will evaluate the meaning of life by using The Purpose in Life Test and the affect of logotherapy in HIV infected youth at HIV-NAT, Thai Red Cross AIDS Research Centre and King Chulalongkorn Memorial Hospital.
Study Overview
Detailed Description
In the HAART era, HIV infected children can live longer and will grow up to become teenagers.
However, some may develop psychosocial problems because they have lost family members, experienced poverty, social discrimination etc. Being a normal teenager is tough and is the most complex period of his/her life.
This is the period when most teenagers will find their identity and reasons for living.
Therefore it is believed that interventions may help HIV-infected teenagers better deal with life.
For this study, logotherapy, a therapy that will help a person to discover his/her purpose in life, live meaningful life, and attain self-esteem was used.
The success of the intervention was evaluated by using The Purpose in Life Test.
Study Type
Interventional
Enrollment (Actual)
48
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
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Bangkok, Thailand, 10330
- HIV-NAT, The Thai Red Cross AIDS Research Centre
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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
16 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 16-24 years
- HIV seropositive
- HIV disclosed
- Understand Thai language
- Parent signed written informed consent
Exclusion Criteria:
- Mental or psychological disorder or having active suicidal idea or attempt
- Having no permanent address
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment arm (logotherapy)
Participants in Arm I will attend the logotherapy group sessions by the trained psychologist for 4 visits (see Table II, III).
The number of participants in group sessions will be 20 participants per group.
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Logotherapy is therapy during which the interaction between the therapist and the client centres on the topic of meaning.
The problems that the clients experience are presented to the client as inseparable parts of his everyday life.
The client is then challenged to discover his/her meaning and to take responsibility in facing up to his/her problem.
This approach is aimed at helping the client to deal and understand what his /her existences entail.
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No Intervention: Control arm (general health education)
Participants in Arm II will attend the routine health education by the nurse.
The number of participants in group session will be 20 participants per group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PIL score
Time Frame: week 48
|
Change of PIL score at baseline and follow up visit between the two arms
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week 48
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
QOL
Time Frame: 48 weeks
|
48 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Arunya Tuicomepee, PhD, Chulalongkorn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
July 17, 2012
First Submitted That Met QC Criteria
July 17, 2012
First Posted (Estimate)
July 19, 2012
Study Record Updates
Last Update Posted (Estimate)
August 18, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- HIV-NAT 109
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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