WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt

Обзор

The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).

Подробное описание

R61 Phase: In this "proof-of-concept" phase, interventionists will administer 12 weeks of WellPATH-PREVENT in 40 middle-aged and older adults who have been discharged after being hospitalized for suicidal ideation or suicide attempt. The interventionist will help the patient incorporate the appropriate data (i.e., triggers, negative emotions, cognitive reappraisal techniques) into the tablet, train the patients on how to use the tablet, and coach them during the 12 weeks. There will be 4 assessments: At study entry (admission/during hospitalization), hospital discharge, 6, and 12 weeks. An EEG will be conducted upon entry into the study, at Week 6, and at Week 12.

R33 Phase: 75 middle-aged and older adults who have been recently discharged after a hospitalization for suicidal ideation or attempt will be recruited and randomized to an optimized version of WellPATH-PREVENT (Week 6 and Week 12 duration based on R61 results) or to Attention Control-Usual Care with a tablet (AC-UC). There will be 5 assessments: At study entry (admission/during hospitalization), discharge, 6, 12 and 24 weeks. Participants who exit the study prior to completion will be invited to have an assessment before termination as close to the scheduled time point as possible. Psychiatrically re-hospitalized participants will not be dropped from the study but will have an additional assessment and will continue the assessments as scheduled based on their initial hospitalization.

Вмешательства

• Поведенческое WellPATH-PREVENT
  WellPATH-PREVENT is a novel personalized, easy to use, mainly stand-alone mobile intervention which focuses on the exclusive use of the WellPATH tablet app and includes training meetings during hospitalization, and virtual post-discharge coaching meetings. The meetings aim to: a) identify stressors and triggers of negative emotions associated with increased suicidal ideation or with suicidal behavior; b) develop techniques (text or video) to increase cognitive reappraisal ability; c) incorporate
• Поведенческое Optimized WellPATH-PREVENT
  The Optimized WellPATH-PREVENT intervention will be as described above, but based on the results of the Proof-of-Concept (R61) Phase, an expert committee will help select the duration (6 or 12 weeks) that shows greater improvement in cognitive reappraisal.

Первичные конечные точки

• Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61 [Срок оценки: Study Entry, Week 6, Week 12]
• Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33 [Срок оценки: Study Entry, Week 6, Week 12, Week 24]
• Change in Self-Reported Affect - R61 [Срок оценки: Study Entry, Week 6, Week 12]
• Change in Self-Reported Affect - R33 [Срок оценки: Study Entry, Week 6, Week 12, Week 24]
• Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61 [Срок оценки: Study Entry, Week 6, Week 12]
• Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33 [Срок оценки: Study Entry, Week 6, Week 12, Week 24]
• Change in Client Satisfaction with Treatment (CSQ) - R61 [Срок оценки: Week 6, Week 12]
• Change in Client Satisfaction with Treatment (CSQ) - R33 [Срок оценки: Week 6, Week 12, Week 24]
• Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61 [Срок оценки: Weekly from Study Entry to Week 12 (R61)]
• Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33 [Срок оценки: Weekly from Study Entry to Week 24]

Критерии участия

Критерии включения

• 50-90 years old
• Diagnosis (based on a modified SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any DSM-5 except: current diagnosis of Psychotic Disorder; diagnosis of Dementia
• Recent hospitalization for suicidal ideation or suicide attempt; at hospital admission, Columbia Suicide Severity Rating Scale (CSSR-S) ≥ 2, "Non-specific Active Suicidal Thoughts."
• We will also include patients on psychotropics and on after-care community psychotherapy.

Критерии исключения

• Current diagnosis of Psychotic Disorders; Diagnosis of Dementia
• Cognitive Impairment (MMSE ≤ 24)
• Acute or severe medical illness (i.e., delirium; decompensated cardiac, liver or kidney failure; major surgery; stroke or myocardial infarction during the three months prior to entry
• Aphasia, sensory problems, and/or inability to speak English.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• New York Presbyterian Hospital/Weill Cornell Medicine — New York
• Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine — White Plains

Идентификаторы

NCT: NCT05183230 · 21-12024207 · R61MH128516 · R33MH128516

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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