Lay-Delivered Behavioral Activation in Senior Centers

Обзор

In response to large numbers of senior center clients who suffer untreated depression and the dearth of geriatric mental health providers, the investigators have simplified Behavioral Activation to be delivered by lay volunteers ("Do More, Feel Better"; DMFB). The focus of Behavioral Activation is to guide clients to reengage in daily pleasant and rewarding activities, and reduce depressive symptoms. If the investigators can show that the lay delivery model has positive impact in comparison to MSW-delivered Behavioral Activation, the investigators will have identified an effective intervention that can be used by a large untapped workforce of older adult volunteers across the nation.

Подробное описание

This Collaborative R01 application (UW, Cornell, USF) proposes to conduct an effectiveness trial of lay-delivered Behavioral Activation ("Do More, Feel Better"; DMFB), in comparison to MSW-delivered Behavioral Activation (MSW BA), for depressed (PHQ-9\>10 and Ham-D\>14) older (60+) senior center clients. The primary aim tests the effectiveness of DMFB, in comparison to MSW BA, on increasing overall activity level (target) and reducing depression symptoms. The investigators will test whether increased activity level predicts greater reduction in depression severity and whether increased activity's impact on depression is non-inferior across conditions. Secondarily, the investigators will test hypotheses associated with overall functioning, satisfaction with treatment, and client-level moderators. Lastly the investigators will explore longer-term client outcomes, delivery cost, and preparing for sustainability by exploring client, provider, and center factors related to intervention fidelity.

Вмешательства

• Поведенческое Volunteer-delivered Behavioral Activation
  Behavioral Activation as delivered by trained volunteers
• Поведенческое Master's level clinician-delivered Behavioral Activation
  Behavioral Activation as delivered by trained master's level clinicians

Первичные конечные точки

• Hamilton Rating Scale for Depression (HAM-D) [Срок оценки: Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts]
• Behavioral Activation Scale (BADS) [Срок оценки: Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts]

Вторичные конечные точки (2)

• World Health Organization Disability Assessment Schedule (WHODAS II) [Срок оценки: Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts]
• Client Satisfaction with Treatment (CSQ)- 3 Item [Срок оценки: Administered at 3, 6, and 9 weeks after treatment starts]

Критерии участия

Client Participants (anticipated enrollment: 288)

Критерии включения

Referral to study (stage 1):

• Age ≥ 60 years.
• Attends one of 18 participating Seattle, NYC, or Tampa area senior centers.
• Patient Health Questionnaire (PHQ-9) score of ≥10 via routine screening.

Research assessment (stage 2):

• Clinically-assessed HAM-D>14
• Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19
• Off antidepressants or on a stable dose for 12 weeks.
• Capacity to provide written consent for both research assessment and the BA intervention.

Client Participants Exclusion Criteria:

• Current active suicidal ideation.
• Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-V (Structure Clinical Interview for DSM-V).
• Severe or life-threatening medical illness (e.g., end stage organ failure).
• Inability to speak English or Spanish

Volunteer Participants (anticipated enrollment: 36) Inclusion Criteria

• Age ≥ 60 years.
• Attends one of the participating Seattle, NYC, or Tampa-area senior centers.

Volunteer Participants Exclusion Criteria

• Current major depressive disorder, alcohol or substance abuse, or manic, hypomanic, or psychotic symptoms (SCID-V);
• Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19;
• Inability to speak and read English or Spanish

Clinician Participants (anticipated enrollment: 36) Inclusion Criteria

• Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
• English or Spanish Speaking
• Capacity to provide consent for all study procedures
• Willing to audio record study sessions for supervision and evaluation

Clinician Participants Exclusion Criteria

• Non-English or Non-Spanish speaking
• Does not hold a Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
• Unable to provide consent
• Unwilling to audio record study sessions for supervision and evaluation

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 · 25 центров

• Brandon Senior Center — Brandon
• Gardenville Dining & Activity Center — Gibsonton
• Ruskin Senior Center — Ruskin
• JL Young Apartments (Senior Housing) — Tampa
• Oaks at Riverview Senior Center — Tampa
• Jewish Towers Senior Housing — Tampa
• Town 'n Country Senior Center — Tampa
• Progress Village Senior Center — Tampa
• … и ещё 17 центров

Публикации

• Raue PJ, Sirey JA, Gum A, Hawrilenko M, Fisher DM. Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres. BMJ Open. 2022 Aug 23;12(8):e066497. doi: 10.1136/bmjopen-2022-066497. PMID 35998966

Идентификаторы

NCT: NCT04621877 · STUDY00011434 · R01MH124975

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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