Anxiety, Minority Stress, Psychological Stress
Conditions
Keywords
Ashwagandha, LGBTQ health, Withania somnifera
Brief summary
Sexual and gender minority adults often experience elevated levels of chronic stress due to stigma, discrimination, and social adversity, commonly referred to as minority stress. This persistent stress is associated with increased anxiety, mood disturbances, impaired sleep quality, and reduced quality of life. There is a need for safe, non-pharmacological interventions that can support mental well-being in this population. This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Ashwagandha (Withania somnifera) root extract in reducing stress and improving anxiety and sleep quality in adults experiencing minority stress. A total of 80 adults aged 18 to 45 years who self-identify as sexual or gender minorities and report moderate to high perceived stress will be enrolled. Participants will be randomly assigned to receive either Ashwagandha root extract (300 mg capsules taken twice daily) or an identical placebo for 8 weeks. Efficacy will be assessed using validated psychological and quality-of-life questionnaires, including the Perceived Stress Scale, Depression Anxiety Stress Scale, Pittsburgh Sleep Quality Index, and other mood and minority stress measures. Salivary cortisol will be measured as a biological marker of stress. Safety will be evaluated through monitoring of adverse events throughout the study.
Detailed description
Minority stress is a well-established contributor to mental health disparities among sexual and gender minority populations. Chronic exposure to stigma, discrimination, and social rejection activates stress-related neuroendocrine pathways, including dysregulation of the hypothalamic-pituitary-adrenal axis, leading to sustained elevations in cortisol and adverse psychological outcomes such as anxiety, mood disturbances, and poor sleep quality. Ashwagandha (Withania somnifera) is a traditional Ayurvedic medicinal herb recognized for its adaptogenic properties. It has been shown to modulate stress responses, reduce cortisol levels, and improve psychological well-being and sleep in stressed adults. However, its effects have not been specifically evaluated in individuals experiencing minority stress. This is a single-center, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of Ashwagandha root extract in adults experiencing minority stress. Eighty eligible participants will be randomized in a 1:1 ratio to receive either Ashwagandha root extract (300 mg capsules taken orally twice daily) or an identical placebo for a duration of 8 weeks. Study assessments will be conducted at baseline, Week 4, and Week 8. Primary efficacy will be evaluated using the Perceived Stress Scale (PSS-10). Secondary outcomes include measures of anxiety, mood, sleep quality, quality of life, minority stress experiences, and salivary cortisol levels. Safety will be assessed through systematic recording of treatment-emergent adverse events and serious adverse events. The results of this study will provide clinical evidence regarding the role of Ashwagandha supplementation as a supportive intervention for stress, anxiety, and sleep disturbances in sexual and gender minority adults.
Interventions
DIETARY_SUPPLEMENTAshwagandha Root Extract
Ashwagandha (Withania somnifera) root extract is a standardized herbal dietary supplement formulated as oral capsules containing 300 mg of extract. Participants will take two capsules daily, one in the morning and one in the evening, for 8 weeks.
OTHERPlacebo Capsule
The placebo consists of an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take two capsules daily for 8 weeks.
Sponsors
SF Research Institute, Inc.
Ixoreal Biomed Private Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Self-identified as a sexual or gender minority (e.g., lesbian, gay, bisexual, transgender, queer, non-binary). 2. Aged 18-45 years. 3. Moderate to high perceived stress levels (PSS-10 total score \>14). 4. Willing to provide written informed consent.
Exclusion criteria
1. Current psychiatric diagnosis (e.g., major depressive disorder, bipolar disorder, psychosis). 2. Use of anti-anxiety or sleep medication (including sleep aids, cannabis or melatonin) in the last 3 months. 3. Known allergy or intolerance to Ashwagandha. 4. Any chronic illness that may confound the results (e.g., known liver illness, severe insomnia, or neurological disorders).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress Scale (PSS-10) Score | Baseline, Week 4, and Week 8 | The Perceived Stress Scale (PSS-10) is a validated 10-item self-reported questionnaire that measures perceived stress over the previous month. Each item is scored from 0 (never) to 4 (very often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (worse outcome). This outcome measures the mean change from baseline in PSS-10 total score, where a reduction in score indicates improvement in perceived stress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Anxiety Stress Scale (DASS-21) Scores | Baseline, Week 4, and Week 8 | The Depression Anxiety Stress Scale-21 (DASS-21) is a validated 21-item questionnaire assessing symptoms of depression, anxiety, and stress. Each item is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Each subscale score (Depression, Anxiety, Stress) ranges from 0 to 21, and the total score ranges from 0 to 63. Higher scores indicate greater symptom severity (worse outcome). This outcome measures the mean change from baseline in DASS-21 total and subscale scores, where a reduction in score indicates improvement in psychological symptoms. |
| Change in Pittsburgh Sleep Quality Index (PSQI) Score | Baseline, Week 4, and Week 8 | The Pittsburgh Sleep Quality Index (PSQI) is a validated questionnaire assessing subjective sleep quality and disturbances over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome). This outcome measures the mean change from baseline in PSQI global score, where a reduction in score indicates improvement in sleep quality. |
| Change in Minority Stress Measured by DHEQ-S-12 | Baseline, Week 4, and Week 8 | The Daily Heterosexist Experiences Questionnaire - Short Form (DHEQ-S-12) is a validated 12-item instrument assessing experiences of minority stress. Each item is scored from 0 to 5. The total score ranges from 0 to 60, with higher scores indicating greater minority stress experiences (worse outcome). This outcome measures the mean change from baseline in DHEQ-S-12 total score, where a reduction in score indicates improvement in minority stress experiences. |
| Change in Quality of Life Measured by WHOQOL-BREF | Baseline, Week 4, and Week 8 | The WHOQOL-BREF is a validated 26-item questionnaire assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life (better outcome). This outcome measures the mean change from baseline in WHOQOL-BREF domain scores, where an increase in score indicates improvement in quality of life. |
| Change in Profile of Mood States (POMS) Score | Baseline, Week 4, and Week 8 | The Profile of Mood States (POMS) is a validated questionnaire assessing mood disturbance across six domains: tension, depression, anger, vigor, fatigue, and confusion. The Total Mood Disturbance (TMD) score typically ranges from -32 to 200 (depending on scoring method), with higher scores indicating greater mood disturbance (worse outcome). This outcome measures the mean change from baseline in POMS Total Mood Disturbance and subscale scores, where a reduction in TMD score indicates improvement in mood state. |
| Change in Salivary Cortisol Awakening Response | Baseline and Week 8 | Change in cortisol awakening response measured using salivary cortisol samples. |
| Change in Bedtime Salivary Cortisol Level | Baseline and Week 8 | Change in bedtime salivary cortisol as a biomarker of stress regulation. |
| Incidence of Treatment-Emergent Adverse Events | Baseline, Week 4, and Week 8 | Number and proportion of participants experiencing treatment-emergent adverse events. |
| Incidence of Treatment-Emergent Serious Adverse Events | Baseline, Week 4, and Week 8 | Number and proportion of participants experiencing treatment-emergent serious adverse events. |
Countries
United States
Contacts
CONTACTDr. John Ademola
Outcome results
None listed