Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CIHR Canadian HIV Trials Network | NETWORK |
| Unity Health Toronto | OTHER |
| AIDS Committee of Toronto | OTHER |
| Factor-Inwentash Faculty of Social Work, University of Toronto |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive remediation group therapy | Experimental | 8 weekly 3-hour sessions of CRGT |
|
| Mutual aid support group | Active Comparator | 8 weekly 3-hour sessions of HIV group therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRGT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Session Attendance | Number of Participants who Attended at least 80% of the Group Sessions. | 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. | Three months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stress | Assessed by the 'HIV/AIDS Stress Scale' at three time points. Score from 0 to 116. Lower scores mean better outcomes. | Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21) |
| Sustained Use of Brain Training Activities |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sharon L Walmsley, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDS Committee of Toronto (ACT) | Toronto | Ontario | M4Y1Y5 | Canada | ||
| St. Michael's Hospital Neurobehavioral Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31676660 | Derived | Eaton AD, Walmsley SL, Craig SL, Rourke SB, Sota T, McCullagh JW, Fallon BA. Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada. BMJ Open. 2019 Oct 31;9(10):e033183. doi: 10.1136/bmjopen-2019-033183. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Remediation Group Therapy | 8 weekly 3-hour sessions of CRGT CRGT: 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. |
| FG001 | Mutual Aid Support Group | 8 weekly 3-hour sessions of HIV group therapy HIV group therapy: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Remediation Group Therapy | 8 weekly 3-hour sessions of CRGT CRGT: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility - Session Attendance | Number of Participants who Attended at least 80% of the Group Sessions. | Posted | Count of Participants | Participants | Three months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Remediation Group Therapy | 8 weekly 3-hour sessions of CRGT CRGT: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Eaton | University of Toronto | 4169788895 | andrew.eaton@utoronto.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2017 | Sep 28, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2017 | Dec 4, 2017 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
This is a pilot, parallel design, randomized, controlled trial (RCT) that will allocate a sample (n=16) of people (≥ 40 yrs old) aging with HIV who have been diagnosed with MND from St. Michael's Hospital (SMH) in Toronto to either arm 1: 8 weekly 3-hour sessions of CRGT; or arm 2: 8 weekly 3-hour sessions of HIV group therapy.
Not provided
Not provided
Not provided
Not provided
|
| HIV group therapy | Behavioral | 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. |
|
Self-report at three time points |
| 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. | 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. | 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. | Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21) |
| Toronto |
| Ontario |
| M5B1M4 |
| Canada |
| University Health Network, Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| BG001 | Mutual Aid Support Group | 8 weekly 3-hour sessions of HIV group therapy HIV group therapy: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | Three months |
|
|
|
| Other Pre-specified | Change in Stress | Assessed by the 'HIV/AIDS Stress Scale' at three time points. Score from 0 to 116. Lower scores mean better outcomes. | Not Posted | Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21) | Participants |
| Other Pre-specified | Sustained Use of Brain Training Activities | Self-report at three time points | Not Posted | Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21) | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21). Score from 0 to 26 | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21) | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21) | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Mutual Aid Support Group | 8 weekly 3-hour sessions of HIV group therapy HIV group therapy: 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. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |