Attempted Suicide Short Intervention Program for Older Adults (ASSIP-OA): An Evaluation of a Psychosocial Intervention for Suicidal Adults Aged 65+

Официальное название

Attempted Suicide Short Intervention Program for Older Adults (ASSIP-OA): An RCT and a Qualitative Evaluation of a Psychosocial Intervention for Suicidal Adults Aged 65+

Обзор

Older adults are sorely underrepresented in suicide prevention research, despite the fact that suicide rates are higher in this age group than in any other age group in Sweden and in many countries worldwide. There are extremely few clinical intervention studies that target this age group, with to date no published studies in Europe. The overall aim is to develop and test a modified version of the Attempted Suicide Short Intervention Program (ASSIP), which the investigators will adapt specifically for older adults (65+). The original ASSIP was developed in Switzerland where it has shown an 80% decrease in risk of new suicide attempts compared to ordinary treatment. In Sweden, ASSIP is currently being tested for persons aged 18+ . The investigators now propose a randomised controlled trial (RCT) to evaluate a modification of ASSIP specifically designed to meet the needs of suicidal persons aged 65 and above, the ASSIP-Older Adult program (ASSIP-OA). Main study questions 1. Compared to treatment as usual (TAU), will the addition of the ASSIP-OA to ordinary treatment have a preventive effect on suicide and suicide attempts within 6, 12, and 24 months following the index episode? 2. Compared to TAU, do ASSIP-OA participants show better improvement in coping skills and psychiatric symptoms a) after the last session and b) at 6-,12- and 24- month follow-up? 3. Is a brief preventive intervention (ASSIP-OA) for older adults feasible, based on its acceptability, appropriateness, deliverability and fidelity? Do participants experience side effects? Do they have fewer days of inpatient care? 4. What kind of challenges and opportunities do a) older adults and b) ASSIP-OA therapists experience in relation to implementing a brief preventive intervention like ASSIP-OA? Are the modifications that the investigators made in ASSIP-OA relevant for older adults?

Вмешательства

• Поведенческое ASSIP-OA
  ASSIP-OA + TAU * First session. Narrative interview focusing on the background of the suicidal crisis. The patient receives a psychoeducational text to read and comment on as homework. * Second session. Video playback. The patient and therapist watch the video recording from session 1 together, periodically pausing the video to comment and add information. * Third session. Compilation of a written case conceptualization of the individual's vulnerability and triggering events that preceded the s
• Другое Treatment as Usual (TAU)
  Antidepressant medication, alone or in combination with other types of psychoactive drugs (sedatives/antipsychotics/hypnotics/mood stabilizers) constitute the cornerstone of treatment for suicidal older adults. Persons with serious depression or treatment-resistant depression may be offered electroconvulsive therapy (ECT). Some persons may receive supportive/therapeutic contacts with mental health professionals (nurses/social workers/psychologists) but no psychosocial interventions designed spec

Первичные конечные точки

• New suicidal episode which includes suicide attempt or death by suicide [Срок оценки: Follow-ups at 6, 12 and 24 months]

Вторичные конечные точки (6)

• Severity of suicidal ideation [Срок оценки: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups.]
• Depressive symptoms [Срок оценки: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups]
• Anxiety [Срок оценки: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups]
• Coping [Срок оценки: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups]
• Health-related quality of life [Срок оценки: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups]
• Health-care utilization [Срок оценки: 12- and 24-month follow-ups.]

Критерии участия

Критерии включения

• Age 65 and above at time of index suicide attempt or hospitalisation for serious suicidal plans.
• A mental health care contact during the active treatment period.
• Capable of understanding study procedures and providing informed consent.

Критерии исключения

• Clinical diagnosis of dementia or MoCa score less than -2 standard deviations from the normative score for education and age (Borland et al., 2017). Ongoing delirium, or any other condition impeding the comprehension of the study's procedures and implications that hinder the provision of informed consent.
• Severe ongoing psychosis, severe ongoing substance use disorder, emotionally instable personality syndrome and any other condition that would require longer specialized treatment to reduce future suicidal behaviour (e.g. DBT).
• Terminal illness.
• Insufficient knowledge of the Swedish language (requires interpreter).
• Aphasia or other severe communication issue or severe hearing and/or severe visual impairment that render the intervention unfeasible despite corrective aids.

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

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 2 центра

• Södra Älvsborg Hospital — Borås
• Sahlgrenska University Hospital — Gothenburg

Публикации

• Hed S, Berg AI, Tillfors M, Ehnvall A, Westrin A, Wiktorsson S, Gysin-Maillart A, Waern M. Attempted suicide short intervention program for older adults 65+ (ASSIP-OA): a study protocol for a multicentre randomised controlled trial. BMC Psychiatry. 2025 Jun 6;25(1):588. doi: 10.1186/s12888-025-07016-7. PMID 40481430

Идентификаторы

NCT: NCT06831942 · 2024-07392-01 · 2023-00181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗