MedPath

Harnessing Optimism and Perseverance in the Face of Long COVID-Español

Not Applicable
Not yet recruiting
Conditions
Post-Acute COVID-19 Syndrome
Registration Number
NCT07216040
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Brief Summary

The Harnessing Optimism and Perseverance in the Face of Long COVID (HOPE-LC) program, created by Drs. Eric Watson and Amelia Hicks, is a group therapy model designed to foster resilience, adjustment, and coping skills for those living with chronic Long COVID. HOPE-LC\~Español provides a culturally and linguistically adapted version for Spanish-speaking individuals in Queens, developed with input from Spanish-speaking clinicians, Long COVID experts, and people with lived experience. Partnering with H+H/Elmhurst and H+H/Queens, the project aims to recruit 25 participants and evaluate program feasibility and preliminary efficacy.

Detailed Description

The Harnessing Optimism and Perseverance in the Face of Long COVID (HOPE-LC) program, developed by Drs. Eric Watson (PI) and Amelia Hicks (co-I), is a 12-week online group therapy program tailored specifically to living with Long COVID as a chronic condition. HOPE-LC provides community and hope; fostering resilience, adjustment, and critical coping strategies in the face of this debilitating chronic condition. Since its inception in 2024, the HOPE-LC groups have engaged 20 patients, emphasizing the need for chronic Long COVID therapeutic interventions.

Through HOPE-LC-Espanol the researchers will translate and adapt the HOPE-LC program into Spanish and expand HOPE-LC's reach to underserved Spanish-speaking communities in Queens and NYC. The aims are: (1) To translate and culturally adapt the HOPE-LC program for Spanish-speaking patients in collaboration with the Advisory Board of Spanish-speaking clinicians, Long COVID experts, and individuals with Long COVID lived experience; (2) In collaboration with the partners at H+H/Elmhurst and H+H/Queens, to conduct targeted recruitment to ensure the researchers are engaging specifically with local Hispanic/Latinx communities in Queens; and (3) To complete the HOPE-LC\~Español program for 25 Spanish-speaking individuals experiencing Long COVID within the local Queens community. The researchers will evaluate program feasibility and treatment success to inform future scalability and sustainability as a clinical program.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
25
Inclusion Criteria
  • Age 18 years or older.
  • Speaks and understands Spanish at a level that allows active participation in group-based study procedures.
  • Self-reported history of Long COVID/post-COVID condition of any severity or duration, including ongoing emotional or cognitive symptoms affecting daily functioning or a medical professional has diagnosed you with a Long COVID/post-COVID condition of any severity or duration, including ongoing emotional or cognitive symptoms.
  • Ability to participate in group sessions either in-person or via telehealth (Zoom).
  • Willingness and capacity to provide informed consent.
Exclusion Criteria
  • Presence of severe psychiatric conditions that would preclude participation in group therapy (e.g., active psychosis, suicidal intent requiring immediate intervention).
  • Inability to communicate in Spanish sufficiently to engage meaningfully in group sessions.
  • Cognitive or physical impairments prevent participation in group sessions or completion of surveys, without available accommodations.
  • Concurrent participation in another conflicting interventional trial targeting Long COVID symptoms.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Recruitment rateThroughout the study period, 12 weeks

Number of eligible participants screened and enrolled by referral source

Retention rateThroughout the study period, 12 weeks

Number of participants completing the intervention (defined as attending at least 8 of 12 sessions)

Number of sessions participants attendedThroughout the study period, 12 weeks

Feasibility measured via participant attendance

Number of completed surveysThroughout the study period, 12 weeks

Feasibility measured via number of surveys completed from participant follow-up and study procedures.

Patient SatisfactionPost-treatment (Week 12)

Post-treatment survey assessing participant satisfaction with HOPE-LC\~Español. Items are on a 5-point Likert Scale evaluated agreement to statements about their experience in the program (e.g., feeling heard, learning practical strategies, and willingness to recommend the program). The total score range is 5 - 40, with higher ratings indicating greater satisfaction.

Secondary Outcome Measures
NameTimeMethod
DePaul Symptom QuestionnaireBaseline; 6 weeks, 12 weeks

The DePaul Symptom Questionnaire (DSQ) is a validated tool to assess symptoms, frequency and severity of various symptoms of fatigue and other neurological impairment. Total score range 0-100, with higher scores indicating greater symptom severity and functional impairment.

Brief Illness Perception Questionnaire (BIPQ)Baseline; 6 weeks, 12 weeks

The BIPQ assesses cognitive and emotional representations of illness in 8 items + 1 open-ended causal item. Total score range is 0-80, higher scores mean a more negative perception of illness.

Valued Based Living Questionnaire (VLQ)Baseline; 6 weeks, 12 weeks

Assesses alignment between personal values and daily actions. Two ratings per domain: (1) Importance (1-10) and (2) Consistency with actions (1-10). Total score range is between 4-40. Higher consistency scores reflect greater valued living (better outcome); lower scores reflect minimal valued living (worse outcome).

Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)Baseline; 6 weeks, 12 weeks

The C19-YRSm is a 17-item self-report scale designed to assess the impact of post-COVID symptoms. Items are rated on a scale from 0 (none of this symptom) to 3 (extremely severe level or impact). The scale includes four subscales:

Symptom Severity (Questions 1-10; score range: 0-30) Functional Disability (Questions 11-15; score range: 0-15) Other Symptoms (Question 16; score range: 0-25) Overall Health (Question 17; score range: 0-10)

Full scale from 0-80. Higher scores indicate greater symptom severity and functional impairment.

Patient Health Questionnaire-8 Item (PHQ-8)Baseline; 6 weeks, 12 weeks

Patient health questionnaire-8 (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-8 is an 8-item instrument. Each question is rated on a scale of 0 to 3, total score scale from 0 - 24. Lower scores indicate minimal depression (better outcome) and higher scores indicate severe depression (worse outcome).

Generalized Anxiety Disorder-7 Item (GAD-7)Baseline; 6 weeks, 12 weeks

This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Total scores range from 0-21, with higher scores indicating greater severity of generalized anxiety symptoms.

Trial Locations

Locations (1)

Brain Injury Research Center

🇺🇸

New York, New York, United States

Brain Injury Research Center
🇺🇸New York, New York, United States
Eric Watson, PhD
Contact
2122412221
eric.watson@mountsinai.org
Amelia Hicks, PhD
Contact
2122412221
amelia.hicks@mountsinai.org
Eric Watson
Principal Investigator

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