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Still Climbin': An Intervention to Improve Coping Among Black Sexual Minority Men
NA trial testing CBT Coping Intervention in Discrimination, Social in 369 participants. Terminated before completion.
| Lead sponsor | RAND |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 369 |
| Start date | 9 February 2021 |
| Primary completion | 20 March 2025 |
| Estimated completion | 20 March 2025 |
| Sites | 1 location across United States |
RAND — full company profile →
18 and older, male only, with Discrimination, Social or Health Care Utilization. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Indicator that the individual reported (1) fewer than 1 ambulatory visit AND (2) at least 1 emergency department visit (without subsequent hospitalization) or at least 1 hospitalization in the past 4 months at any of the 3 follow-up assessments (4, 8, and 12 months post-baseline)
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 41 | |
| No-treatment Control | 39 |
For each individual, this measure is the number of components that were received at any time across the 3 follow-up assessments divided by the number of components they were eligible for at any time across the 3 follow-up assessments, expressed as a proportion. 25 components were evaluated and eligibility for each component varies by individual and follow-up period.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | .46 | ± .22 |
| No-treatment Control | .47 | ± .23 |
Average adaptive coping rating on the Brief COPE scale, social support items (higher=better coping; range=1-4)
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 2.60 | ± 0.96 |
| No-treatment Control | 2.50 | ± 0.96 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 2.77 | ± 0.96 |
| No-treatment Control | 2.56 | ± 0.92 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 2.61 | ± 0.92 |
| No-treatment Control | 2.41 | ± 0.91 |
Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention | No-treatment Control |
|---|---|---|---|
| Stroke and other nervous system disorder | Nervous system disorders | — | — |
| Cardiac-related hospitalization | Cardiac disorders | — | — |
| Accidents | Injury, poisoning and procedural complications | — | — |
| General -surgery due to pre-existing conditions | Surgical and medical procedures | — | — |
| Respiratory related hospitalization | Respiratory, thoracic and mediastinal disorders | — | — |
| Infection - hospitalization | Infections and infestations | — | — |
| GI related hospitalization | Gastrointestinal disorders | — | — |
| Kidney failure | Renal and urinary disorders | — | — |
| General hospitalization | Surgical and medical procedures | — | — |
Most-reported serious reactions: Stroke and other nervous system disorder, Cardiac-related hospitalization, Accidents, General -surgery due to pre-existing conditions, Respiratory related hospitalization, Infection - hospitalization, GI related hospitalization, Kidney failure.
Data from ClinicalTrials.gov NCT04587869 adverse events section.
This study consists of a randomized controlled trial of a multi-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). Primary intervention objectives include increasing health care engagement and receipt of evidence-based preventive care, as well as better coping and reduced anticipated and internalized stigma, and medical mistrust among intervention participants.
No peer-reviewed publications indexed yet for this trial.
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