HIV Infections, Mild Cognitive Impairment
Conditions
Keywords
HIV, Cisgender women, African American or Black, Mindfulness
Brief summary
In our Supplement Aim we will conduct a two-arm randomized pilot test of the adapted intervention compared to a usual care control group among 30 African American/Black women with HIV (15/arm) to assess the feasibility and acceptability of the mindfulness-based stress reduction among women with HIV with mild cognitive impairment. Feasibility will be assessed by our ability to (1) recruit, randomize, and retain participants and (2) deliver the intervention per the manual, as well as (3) participants adherence to home practices and assignments. Acceptability will be assessed via qualitative data (focus group input regarding participants' satisfaction with the intervention and intent to continue using the practices), as well quantitative data (satisfaction survey).
Interventions
BEHAVIORALMindfulness
The traditional mindfulness intervention consists of the following: (1) orientation; (2) a series of eight weekly session of 2.5 to 3 hours; (3) a silent retreat during the between weeks 4 and 6; (4) daily home assignments including formal and informal mindfulness practices; and (5) didactic presentations on stress and the consequences of stress.
OTHERUsual Care
The control condition will continue receiving usual care or standard of care.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cisgender females * HIV seropositive * 18 years of age or older * English speaking * An active patient at the local HIV ambulatory clinic in Alabama. * No history of neurological (including dementia diagnosis) * No history of severe psychiatric (e.g., schizophrenia or bipolar disorder) disorders
Exclusion criteria
* Non-English speaking * Appear temporarily impaired (e.g., intoxicated) * Not willing to or legally unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment | Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session. | Feasibility was measured using a four-item feasibility of intervention measure. Each item is scored using a Likert-like scale ranging from 1 completely disagree to 5 completely agree. Higher scores indicate greater feasibility. The minimum total score is 4 points, and the maximum total score is 20. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-based Stress Reduction Mindfulness-based stress reduction sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.
Mindfulness: The traditional mindfulness intervention consists of the following: (1) orientation; (2) a series of eight weekly session of 2.5 to 3 hours; (3) a silent retreat during the between weeks 4 and 6; (4) daily home assignments including formal and informal mindfulness practices; and (5) didactic presentations on stress and the consequences of stress. | 15 |
| Usual Care The control condition will continue receiving usual care or standard of care.
Usual Care: The control condition will continue receiving usual care or standard of care. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Total | Mindfulness-based Stress Reduction |
|---|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 7.4 | 55.7 years STANDARD_DEVIATION 8.5 | 56.9 years STANDARD_DEVIATION 9.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment
Feasibility was measured using a four-item feasibility of intervention measure. Each item is scored using a Likert-like scale ranging from 1 completely disagree to 5 completely agree. Higher scores indicate greater feasibility. The minimum total score is 4 points, and the maximum total score is 20.
Time frame: Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.
Population: This was a feasibility study. The study team was able to randomize participants. The control group did not complete the feasibility scale because they did not participate in the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-based Stress Reduction | Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment | 18.3 score on a scale | Standard Deviation 1.9 |