Meaning of LifeNCT01644383
Meaning of Life in HIV-infected Youths
A study testing logotherapy in people with Meaning of Life, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Meaning of Life
- What is being tested?
- logotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2011to Jun 2015
- 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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-24 years
- HIV seropositive
- HIV disclosed
- Understand Thai language
- Parent signed written informed consent
Who cannot join
- Mental or psychological disorder or having active suicidal idea or attempt
- Having no permanent address
Trial locations and contacts
1 site in 1 country.
Thailand1 site
HIV-NAT, the Thai Red Cross AIDS Research Centre
Bangkok, 10330
About this study
Official title: 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.
Read the 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.
- Conditions
- Meaning of Life
- Being tested
- logotherapy
- Keywords
- meaning of life, logotherapy, HIV-infected teenagers, adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
logotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (logotherapy) | Experimental | 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. Receives: Behavioral: logotherapy |
| Control arm (general health education) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIL score
Change of PIL score at baseline and follow up visit between the two arms
Measured: week 48
Secondary outcomes (1)
QOL
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startFeb 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meaning 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, SEARCH Research Foundation, Wayne State University, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Arunya Tuicomepee, PhD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644383
- Sponsor's protocol ID
- HIV-NAT 109
- Status last verified
- Aug 2016
- First submitted
- 17 Jul 2012
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meaning in Life of Youth Infected With HIV
- ClinicalTrials.gov ID
- NCT01644383
- Acronym / sponsor ID
- HIV-NAT 109
- Conditions
- Meaning of Life
- Keywords
- meaning of life, logotherapy, HIV-infected teenagers, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University, SEARCH Research Foundation, Wayne State University, University of Minnesota
- Study start
- Feb 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Jul 2012 (estimated)
- 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.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm (logotherapy) | Experimental | Behavioral: logotherapyParticipants 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. |
| Control arm (general health education) | No intervention | –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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 16-24 years
- HIV seropositive
- HIV disclosed
- Understand Thai language
- Parent signed written informed consent
Key exclusion criteria (2 listed)
- Mental or psychological disorder or having active suicidal idea or attempt
- Having no permanent address
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 |
|---|---|---|
| logotherapyLogotherapy 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. | Behavioural | Treatment arm (logotherapy) |
Primary outcome
PIL score
Time frame: week 48
Change of PIL score at baseline and follow up visit between the two arms
1 secondary outcome
QOL
Time frame: 48 weeks
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 18 Aug 2016.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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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.
Arunya Tuicomepee, PhD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing logotherapy in people with Meaning of Life, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
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 5 inclusion and 2 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
PIL score (time frame: week 48). 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 18 Aug 2016.