Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)

Обзор

This randomized clinical trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.

Подробное описание

This study evaluates a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social behavior, and it also validates several new techniques for measuring social behavior. mSITE blends brief in-person psychotherapy with a context-triggered mobile smartphone intervention and remote telephone coaching. The investigators will conduct a randomized clinical trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions in comparison to a therapist and device matched condition. The investigators will changes in outcome measures at baseline and Weeks 8, 18, and 30. If found to be effective, a scalable intervention that reduces social isolation in serious mental illness would have significant personal, societal, and economic impact.

Вмешательства

• Поведенческое Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)
  mSITE is a blended intervention that integrates a brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. Participants will attend weekly, in-person sessions for 8 weeks and then 15-minute, remote coaching sessions for 10 weeks. The intervention begins with setting a meaningful recovery goal and then the generic cognitive model is introduced and a simple thought challenging skill is trained to specifically address social avoidance behavi
• Поведенческое Supportive Contact (SC)
  The SC arm will match the mSITE arm on the same amount of individual in-person and coaching, and mobile device contact. Coaching sessions will be semi-structured and consist of setting recovery goals, check-in about symptoms and potential crisis management, flexible discussion involving psychoeducation, instructions for accessing community crisis lines and community resources, and symptom management behaviors that grow out of discussions, with only minimal therapist guidance.

Первичные конечные точки

• Ecological Momentary Assessment [Срок оценки: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.]
• Clinical Assessment Interview for Negative Symptoms [Срок оценки: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.]
• Birchwood Social Functioning Scale [Срок оценки: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.]
• Positive And Negative Syndrome Scale [Срок оценки: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.]
• Passive sensing mobile application [Срок оценки: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.]

Критерии участия

Критерии включения

• Voluntary informed consent to participate and capacity to consent; Age 18 to 65;
• Diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a diagnostic interview and available medical record review;
• Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;
• Be willing and able to speak English at ≥ 6th grade reading level (to read intervention workbook).

Критерии исключения

• Prior cognitive-behavioral therapy in the past 2 years;
• Greater than moderate disorganization on the PANSS (P2- Disorganization item >5);
• Alcohol or substance dependence in past 3 months based on the diagnostic interview;
• Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness);
• Unable to adequately see or manually manipulate a phone;
• Resident of an integrated housing facility that also provides treatment services.

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

Лечение

Центры проведения

США · 1 центр

• University of California - San Diego — San Diego

Идентификаторы

NCT: NCT06865937 · R33MH126094 · 4R33MH126094-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗