An interventional study of CRGT and HIV group therapy in HIV/AIDS, Aging and Mild Cognitive Impairment, sponsored by University Health Network, Toronto. Completed at 3 sites in Canada. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Supportive care
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Among 123 studies in Acquired Immunodeficiency Syndrome with a site in Canada — 9 open to participants now, 13 under way, 2 of them phase 3. Acquired Immunodeficiency Syndrome · Canada.
Among the 123 studies in Acquired Immunodeficiency Syndrome with a site in Canada, this one is the 99th largest by enrollment of the 106 interventional ones that give a count, is one of 5 that started in 2018, is one of 37 with no phase, and was the 93rd registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →9 of the 123 studies in Acquired Immunodeficiency Syndrome with a site in Canada are open now. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in Canada, United States, Argentina and 6 more countries
Ages 18+
Centre hospitalier de l'Université de Montréal (CHUM) · Sites in Canada
Ages 18+
Cara Spence · Sites in Canada
Ages 16+ · Healthy volunteers
University of Toronto · Sites in Canada
Ages 18–89
University of British Columbia · Sites in Canada
Ages 18–45 · Women only · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 40 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
123 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 24 · Phase 3 36 · Phase 4 11
First in 1999; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 114 across the 106 interventional studies, 210 across the 11 observational. Of the 99 that completed or were terminated, 35 (35%) have results posted.
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63 of 123 have an industry lead sponsor. The 10 most frequent:
University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 295 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
University Health Network, Toronto has 5 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Acquired Immunodeficiency Syndrome with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06497504GlaxoSmithKlineStudy of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) | 2027-04-22 |
| NCT06823596University of TorontoThe T Cell Activator of Cell Killing ("TACK") IT ON" STUDY | 2027-11-15 |
Add all 2 to your calendar (.ics) → With an account.
Among the 123 studies in Acquired Immunodeficiency Syndrome with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
CTNPT 029 will test the feasibility and acceptability of cognitive remediation group therapy in older adults living with HIV who have been diagnosed with HIV-associated neurocognitive disorder (HAND). The cognitive remediation therapy will include tablet-based cognitive training and mindfulness-based stress reduction sessions.
Approximately half of the aging HIV-positive population will be affected by HAND, making cognitive impairment related to HIV a significant comorbidity in this population. With the development, access to, and early initiation of modern antiretroviral therapy (ART), HAND is less severe and less common than it once was. However, people who were treated with old therapies, ones that were less effective and with higher rates of toxicity compared to current regimens, or who experienced AIDS defining illnesses, may be affected by HAND more frequently and more severely. Issues with cognition, memory, processing new information, problem solving, and decision making are all potential symptoms.
Psychosocial interventions have been used to decrease stress and depression and improve coping and quality of life in the general aging population experiencing cognitive impairment and depression. These techniques, which can vary widely, have not been fully tested in people aging with HAND.
CTNPT 029 (a pilot trial funded by the CTN) seeks to enroll 16 people at St. Michael's Hospital in Toronto. Study participants will be randomized to either receive cognitive remediation group therapy (CRGT) or standard HIV group therapy (control group). Both group therapies consist of a series of weekly 3-hour sessions led by a certified social worker and a peer. The CRGT group will spend one hour per session on brain training exercises (PositScience Software) and the remaining two hours on mindfulness-based stress reduction (meditation, breathing exercises, etc.). The control group will focus on general health and wellbeing for people aging with HIV. Study investigators will determine the usefulness of the structure of the sessions and the feasibility and acceptability of performing a study of this kind.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8 weekly 3-hour sessions of CRGT
Behavioral: CRGT
8 weekly 3-hour sessions of HIV group therapy
Behavioral: HIV group therapy
Cognitive remediation group therapy (CRGT) will be comprised of 1/3 brain training exercises on tablets using PositScience software by BrainHQ and 2/3 mindfulness-based stress reduction (MBSR) involving various activities such as meditation, breathing exercises, etc. Intervention will comprise of 8 weekly 3-hour sessions.
These groups use a model of mutual aid to encourage peer-based discussion on the effects of living with HIV. Topics are determined by the group; facilitators ensure that safety is maintained throughout and make connections between participants as appropriate. Intervension will comprise of 8 weekly 3-hour sessions.
Feasibility - Session Attendance
Number of Participants who Attended at least 80% of the Group Sessions.
Time frame: Three months
Acceptability - Participant Satisfaction With Group Sessions
Participants will complete the Helping Characteristics of Self-Help and Support Groups Measure that will be complemented by questions about session length, number of sessions, activities used, and evaluation of facilitators. The Helping Characteristics of Self-Help and Support Group Measure contains 22 items that are scored on a 5-point-Likert style scale for a minimum score of 22 and a maximum score of 110. Higher scores indicate better outcome (outcome being satisfaction with support group). There are no subscales.
Time frame: Three months
Change in Stress
Assessed by the 'HIV/AIDS Stress Scale' at three time points. Score from 0 to 116. Lower scores mean better outcomes.
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Sustained Use of Brain Training Activities
Self-report at three time points
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Sustained Use of Mindfulness Strategies
Assessed by the 'Five Facet Mindfulness Questionnaire - Short Form' at three time points. Score from 24 to 120. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21). Score from 0 to 26
Change in Anxiety
Assessed by the 'Anxiety in Cognitive Impairment and Dementia Scale' at three time points. Score from 0 to 26. Lower scores mean better outcomes.
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Change in Coping
Assessed by the 'Coping Self-Efficacy Scale of Health Problems' at three time points. Score from 0 to 30. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
| Milestone | Cognitive Remediation Group Therapy | Mutual Aid Support Group |
|---|---|---|
| Started | 6 | 6 |
| Completed | 5 | 5 |
| Not completed | 1 | 1 |
Number of Participants who Attended at least 80% of the Group Sessions.
| Participants | Cognitive Remediation Group Therapy | Mutual Aid Support Group |
|---|---|---|
| Feasibility - Session Attendance | 5 | 5 |
Participants will complete the Helping Characteristics of Self-Help and Support Groups Measure that will be complemented by questions about session length, number of sessions, activities used, and evaluation of facilitators. The Helping Characteristics of Self-Help and Support Group Measure contains 22 items that are scored on a 5-point-Likert style scale for a minimum score of 22 and a maximum score of 110. Higher scores indicate better outcome (outcome being satisfaction with support group). There are no subscales.
| score on a scale | Cognitive Remediation Group Therapy | Mutual Aid Support Group |
|---|---|---|
| Acceptability - Participant Satisfaction With Group Sessions | 90 (74 to 100) | 85 (58 to 100) |
Assessed by the 'HIV/AIDS Stress Scale' at three time points. Score from 0 to 116. Lower scores mean better outcomes.
Results for this outcome have not been posted.
Self-report at three time points
Results for this outcome have not been posted.
Assessed by the 'Five Facet Mindfulness Questionnaire - Short Form' at three time points. Score from 24 to 120. Higher scores mean better outcomes.
Results for this outcome have not been posted.
Assessed by the 'Anxiety in Cognitive Impairment and Dementia Scale' at three time points. Score from 0 to 26. Lower scores mean better outcomes.
Results for this outcome have not been posted.
Assessed by the 'Coping Self-Efficacy Scale of Health Problems' at three time points. Score from 0 to 30. Higher scores mean better outcomes.
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Remediation Group Therapy | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Mutual Aid Support Group | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Cognitive Remediation Group Therapy | Mutual Aid Support Group | Total |
|---|---|---|---|
| Mean | 51.5 ± 6.72 | 59.7 ± 10.63 | 55.6 ± 8.68 |
| Sex: Female, Male(Participants) | Cognitive Remediation Group Therapy | Mutual Aid Support Group | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 6 | 6 | 12 |
| Race (NIH/OMB)(Participants) | Cognitive Remediation Group Therapy | Mutual Aid Support Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 5 | 4 | 9 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cognitive Remediation Group Therapy | Mutual Aid Support Group | Total |
|---|---|---|---|
| Canada | 6 | 6 | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2018 to primary completion in Dec 2019, 16 months.
Results were first posted in Mar 2024, 4 years 2 months after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 16 months is below that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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