治験レーダーAI | ||
|---|---|---|
治験 NCT06831942（対象：自殺念慮、自殺未遂、自殺）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Attempted Suicide Short Intervention Program for Older Adults (ASSIP-OA): An Evaluation of a Psychosocial Intervention for Suicidal Adults Aged 65+ 132 予防的 予防
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06831942 は 介入研究 臨床試験 で、自殺念慮、自殺未遂、自殺 に関するものです。現在は 募集中 で、2025年10月1日 から開始しています。132 名の参加者 の募集が計画されています。この試験は Vastra Gotaland Region によって主導され、2031年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月18日 です。
概要
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 S...もっと見る
公式タイトル
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+
疾患名
自殺念慮自殺未遂自殺その他の研究識別子
- 2024-07392-01
- 2023-00181 (その他の助成金/資金番号) (FORTE)
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的ASSIP-OA The ASSIP-OA intervention and treatment as usual (TAU) | 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 conceptualiza...もっと見る |
実薬対照薬Treatment as Usual Ordinary treatment | 通常治療 (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 (nurs...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
New suicidal episode which includes suicide attempt or death by suicide | The primary outcome variable at 6-, 12- and 24-month follow-up is any "new suicidal episode," a composite rating that is coded "yes" in the event of a) a new suicide attempt as registered in the participant's medical record or the national hospital register or b) suicide death as registered in the national cause of death register. | Follow-ups at 6, 12 and 24 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Severity of suicidal ideation | Columbia-Suicide Severity Rating Scale (C-SSRS) Scores range from 0-5, where higher scores indicate more severe ideation. | 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 | Montgomery-Åsberg Depression Rating Scale (MADRS) Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression. | 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 | Generalized Anxiety Disorder 7-item scale (GAD-7). Each item yields a score of 0 to 3; the overall score thus ranges from 0 to 21. Higher GAD-7 score indicates more severely elevated anxiety. | 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 | Brief - Coping Orientation to Problems Experienced Inventory (Brief-Cope) 28 item scale 1= I haven't been doing this at all 2= A little bit 3 = A medium amount 4= I've been doing this a lot. Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style. | 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 | EQ-5D-5L . The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: Each dimension has 5 levels: A higher 1-digit number mean a worse outcome. High scores on the EQ VAS mean a better outcome. | 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 | We will assess psychiatric inpatient hospitalizations, as well as the number and type of psychiatric healthcare contacts, based on medical records. | 12- and 24-month follow-ups. |
参加アシスタント
適格基準
対象年齢
高齢者
試験の最低年齢
65 Years
対象性別
全て
- 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.
- 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.
Vastra Gotaland Regionヨーテボリ大学試験中央連絡先
連絡先: Sara Hed, Phd Student, +46735324985, [email protected]
連絡先: Margda Waern, Professor, [email protected]
2 1カ国の場所
Södra Älvsborg Hospital, Borås, 50182, Sweden
Carina Forsberg, 連絡先, +4676-940 29 47, [email protected]
募集中
Sahlgrenska University Hospital, Gothenburg, 41345, Sweden
Sara Hed, 連絡先, +46735324985, [email protected]
募集準備中