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

NCT07216040 | Not Yet Recruiting

• 1 other identifier: STUDY-25-01010
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

Post-Acute COVID-19 Syndrome; group therapy; acceptance and commitment therapy; Spanish-speaking

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Number of eligible participants screened and enrolled by referral source

  Throughout the study period, 12 weeks

• Retention rate

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

  Throughout the study period, 12 weeks

• Number of sessions participants attended

  Feasibility measured via participant attendance

  Throughout the study period, 12 weeks

• Number of completed surveys

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

  Throughout the study period, 12 weeks

• Patient Satisfaction

  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.

  Post-treatment (Week 12)

Secondary Outcomes (6)

• DePaul Symptom Questionnaire

  Baseline; 6 weeks, 12 weeks

• Brief Illness Perception Questionnaire (BIPQ)

  Baseline; 6 weeks, 12 weeks

• Valued Based Living Questionnaire (VLQ)

  Baseline; 6 weeks, 12 weeks

• Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)

  Baseline; 6 weeks, 12 weeks

• Patient Health Questionnaire-8 Item (PHQ-8)

  Baseline; 6 weeks, 12 weeks

Study Arms (1)

Patients Living with Chronic Long-COVID

EXPERIMENTAL

Spanish-speaking patients in the HOPE-LC program.

Behavioral: HOPE-LC~Espanol

Interventions

HOPE-LC~Espanol BEHAVIORAL

12-week online group therapy program grounded in principles of Acceptance and Commitment Therapy and 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.

Patients Living with Chronic Long-COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Brain Injury Research Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Watson

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

• Amelia Hicks, PhD

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Watson, PhD

CONTACT

212-241-2221; eric.watson@mountsinai.org

Amelia Hicks, PhD

CONTACT

212-241-2221; amelia.hicks@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Single arm
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single arm pre-post design. Focus is on feasibility with preliminary efficacy as secondary focus.

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 14, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to eric.watson@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (link to be determined).

Locations

US (1)