HIVNCT00186550
Group Psychotherapy for People With HIV
A study testing Supportive Expressive Group Psychotherapy and Education in people with HIV and Depression, run by Stanford University at 1 site in United States.
Trial summary
This study will examine the effectiveness of supportive-expressive group therapy plus education compared with an educational intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV or AIDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Depression, Risk-taking
- What is being tested?
- Supportive Expressive Group Psychotherapy and Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2000
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) a positive HIV diagnosis (either symptomatic or asymptomatic), 2) at least eighteen years of age, 3) English language skill (to complete questionnaires and participate, if assigned, to the group psychotherapy condition) and, 4) geographical proximity to groups in order to attend if assigned.
Who cannot join
- 1) severe psychiatric disorders (i.e. schizophrenia or other psychotic disorders)who would not be appropriate for participating in the group intervention, 2) active tuberculosis, 3) acute intoxication, 4) participation in an ongoing HIV/AIDS support group or 5) suicidal/homicidal ideation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Group Psychotherapy for People With HIV
This study will examine the effectiveness of supportive-expressive group therapy plus education compared with an educational intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV or AIDS.
Read the detailed description
The major goal of this project is to examine the effectiveness of supportive-expressive group therapy plus education in comparison to an educationally intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV/AIDS.
- Conditions
- HIV, Depression, Risk-taking, Pain
- Being tested
- Supportive Expressive Group Psychotherapy, Education
- Medical subject headings
- Depression, Risk-Taking, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Expressive Group PsychotherapyBehavioural
EducationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Spiegel, Stanford University
- Investigators
- David Spiegel, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186550
- Sponsor's protocol ID
- R01MH054930-04
- Other IDs
- R01MH054930-04
- Status last verified
- Dec 2013
- First submitted
- 13 Sep 2005
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Power R, Gore-Felton C, Vosvick M, Israelski DM, Spiegel D. HIV: effectiveness of complementary and alternative medicine. Prim Care. 2002 Jun;29(2):361-78. doi: 10.1016/s0095-4543(01)00013-6.
PubMed 12391716Vosvick M, Gore-Felton C, Ashton E, Koopman C, Fluery T, Israelski D, Spiegel D. Sleep disturbances among HIV-positive adults: the role of pain, stress, and social support. J Psychosom Res. 2004 Nov;57(5):459-63. doi: 10.1016/j.jpsychores.2004.03.003.
PubMed 15581649Gore-Felton C, Vosvick M, Bendel T, Koopman C, Das B, Israelski D, Herrera M, Litzenberg K, Spiegel D. Correlates of sexually transmitted disease infection among adults living with HIV. Int J STD AIDS. 2003 Aug;14(8):539-46. doi: 10.1258/095646203767869156.
PubMed 12935384Power R, Koopman C, Volk J, Israelski DM, Stone L, Chesney MA, Spiegel D. Social support, substance use, and denial in relationship to antiretroviral treatment adherence among HIV-infected persons. AIDS Patient Care STDS. 2003 May;17(5):245-52. doi: 10.1089/108729103321655890.
PubMed 12816618Gore-Felton C, Vosvick M, Power R, Koopman C, Ashton E, Bachmann MH, Israelski D, Spiegel D. Alternative therapies: a common practice among men and women living with HIV. J Assoc Nurses AIDS Care. 2003 May-Jun;14(3):17-27. doi: 10.1177/1055329003014003002.
PubMed 12800809Koopman C, Gore-Felton C, Azimi N, O'Shea K, Ashton E, Power R, De Maria S, Israelski D, Spiegel D. Acute stress reactions to recent life events among women and men living with HIV/AIDS. Int J Psychiatry Med. 2002;32(4):361-78. doi: 10.2190/CK2N-33NV-3PVF-GLVR.
PubMed 12779186Vosvick M, Koopman C, Gore-Felton C, Thoresen C, Krumboltz J, Spiegel D. Relationship of functional quality of life to strategies for coping with the stress of living with HIV/AIDS. Psychosomatics. 2003 Jan-Feb;44(1):51-8. doi: 10.1176/appi.psy.44.1.51.
PubMed 12515838Turner-Cobb JM, Gore-Felton C, Marouf F, Koopman C, Kim P, Israelski D, Spiegel D. Coping, social support, and attachment style as psychosocial correlates of adjustment in men and women with HIV/AIDS. J Behav Med. 2002 Aug;25(4):337-53. doi: 10.1023/a:1015814431481.
PubMed 12136496Koopman C, Gore-Felton C, Marouf F, Butler LD, Field N, Gill M, Chen XH, Israelski D, Spiegel D. Relationships of perceived stress to coping, attachment and social support among HIV-positive persons. AIDS Care. 2000 Oct;12(5):663-72. doi: 10.1080/095401200750003833.
PubMed 11218551Gore-Felton C, Butler LD, Koopman C. HIV disease, violence, and post-traumatic stress. Focus. 2001 May;16(6):5-6. No abstract available.
PubMed 11547387
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Group Psychotherapy for People With HIV
- ClinicalTrials.gov ID
- NCT00186550
- Acronym / sponsor ID
- R01MH054930-04
- Conditions
- HIV, Depression, Risk-taking, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study completion
- Nov 2000 (actual)
- First posted
- 16 Sep 2005 (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.
This study will examine the effectiveness of supportive-expressive group therapy plus education compared with an educational intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV or AIDS.
Detailed description
The major goal of this project is to examine the effectiveness of supportive-expressive group therapy plus education in comparison to an educationally intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV/AIDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) a positive HIV diagnosis (either symptomatic or asymptomatic), 2) at least eighteen years of age, 3) English language skill (to complete questionnaires and participate, if assigned, to the group psychotherapy condition) and, 4) geographical proximity to groups in order to attend if assigned.
Key exclusion criteria (1 listed)
- 1) severe psychiatric disorders (i.e. schizophrenia or other psychotic disorders)who would not be appropriate for participating in the group intervention, 2) active tuberculosis, 3) acute intoxication, 4) participation in an ongoing HIV/AIDS support group or 5) suicidal/homicidal ideation.
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 |
|---|---|---|
| Supportive Expressive Group Psychotherapy | Behavioural | – |
| Education | Behavioural | – |
Primary outcome
Not reported in the source record.
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 4 Dec 2013.
- Background: PubMed 12391716Power R, Gore-Felton C, Vosvick M, Israelski DM, Spiegel D. HIV: effectiveness of complementary and alternative medicine. Prim Care. 2002 Jun;29(2):361-78. doi: 10.1016/s0095-4543(01)00013-6.
- Results publication: PubMed 15581649Vosvick M, Gore-Felton C, Ashton E, Koopman C, Fluery T, Israelski D, Spiegel D. Sleep disturbances among HIV-positive adults: the role of pain, stress, and social support. J Psychosom Res. 2004 Nov;57(5):459-63. doi: 10.1016/j.jpsychores.2004.03.003.
- Results publication: PubMed 12935384Gore-Felton C, Vosvick M, Bendel T, Koopman C, Das B, Israelski D, Herrera M, Litzenberg K, Spiegel D. Correlates of sexually transmitted disease infection among adults living with HIV. Int J STD AIDS. 2003 Aug;14(8):539-46. doi: 10.1258/095646203767869156.
- Results publication: PubMed 12816618Power R, Koopman C, Volk J, Israelski DM, Stone L, Chesney MA, Spiegel D. Social support, substance use, and denial in relationship to antiretroviral treatment adherence among HIV-infected persons. AIDS Patient Care STDS. 2003 May;17(5):245-52. doi: 10.1089/108729103321655890.
- Results publication: PubMed 12800809Gore-Felton C, Vosvick M, Power R, Koopman C, Ashton E, Bachmann MH, Israelski D, Spiegel D. Alternative therapies: a common practice among men and women living with HIV. J Assoc Nurses AIDS Care. 2003 May-Jun;14(3):17-27. doi: 10.1177/1055329003014003002.
- Results publication: PubMed 12779186Koopman C, Gore-Felton C, Azimi N, O'Shea K, Ashton E, Power R, De Maria S, Israelski D, Spiegel D. Acute stress reactions to recent life events among women and men living with HIV/AIDS. Int J Psychiatry Med. 2002;32(4):361-78. doi: 10.2190/CK2N-33NV-3PVF-GLVR.
- Results publication: PubMed 12515838Vosvick M, Koopman C, Gore-Felton C, Thoresen C, Krumboltz J, Spiegel D. Relationship of functional quality of life to strategies for coping with the stress of living with HIV/AIDS. Psychosomatics. 2003 Jan-Feb;44(1):51-8. doi: 10.1176/appi.psy.44.1.51.
- Results publication: PubMed 12136496Turner-Cobb JM, Gore-Felton C, Marouf F, Koopman C, Kim P, Israelski D, Spiegel D. Coping, social support, and attachment style as psychosocial correlates of adjustment in men and women with HIV/AIDS. J Behav Med. 2002 Aug;25(4):337-53. doi: 10.1023/a:1015814431481.
- Results publication: PubMed 11218551Koopman C, Gore-Felton C, Marouf F, Butler LD, Field N, Gill M, Chen XH, Israelski D, Spiegel D. Relationships of perceived stress to coping, attachment and social support among HIV-positive persons. AIDS Care. 2000 Oct;12(5):663-72. doi: 10.1080/095401200750003833.
- Results publication: PubMed 11547387Gore-Felton C, Butler LD, Koopman C. HIV disease, violence, and post-traumatic stress. Focus. 2001 May;16(6):5-6. No abstract available.
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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.
David Spiegel, M.D. principal investigator
Stanford 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 Supportive Expressive Group Psychotherapy and Education in people with HIV and Depression, run by Stanford University at 1 site in United States.
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 4 Dec 2013. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00186550, which also lists 10 linked publications.
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 4 Dec 2013.