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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-00181 | Other Grant/Funding Number | FORTE |
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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASSIP-OA | Experimental | The ASSIP-OA intervention and treatment as usual (TAU) |
|
| Treatment as Usual | Active Comparator | Ordinary treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASSIP-OA | Behavioral | ASSIP-OA + TAU
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Alliance | Working Alliance Inventory-Short Revised (WAI-SR) measures therapeutic alliance on 12 items on a 7-point Likert scale from 1 = "never" to 7 = "always. " | After the second ASSIP-OA session approx 2 weeks after of study inclusion |
| Side effects |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Hed, Phd Student | Contact | +46735324985 | sara.hed@gu.se | |
| Margda Waern, Professor | Contact | margda.waern@neuro.gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Margda Waern, Professor | Department of Psychiatry, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södra Älvsborg Hospital | Recruiting | Borås | 50182 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40481430 | Derived | 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. |
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The individual participant data (IPD) from this study will not be shared publicly, as we do not have ethical approval for individual data sharing. Any inquiries regarding access to the data should be directed to the Swedish Ethical Review Board, which oversees ethical considerations related to data access and use: registrator@etikprovning.se
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| Treatment as Usual (TAU) | Other | 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 specifically for suicidal older adults are offered as part of ordinary treatment at the participating clinics. |
|
| 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. |
Negative Effects Questionnaire (NEQ). It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances, as well as one open-ended question. |
| After the last ASSIP-OA session approx 5 weeks after study inclusion |
| Feasibility measure Acceptability | Acceptability will be addressed in the qualitative interviews with patients post intervention. | Post intervention approx after 5 weeks |
| Feasibility measure - Appropriatness | Appropriateness is measured by Cronbach alpha and mean inter-item correlation in our questionnaires. | Post intervention (5-weeks) and at follow upp after 6, 12 and 24 months. |
| Feasibility measure - Deliverability | Deliverability is measured by examining that all components of the ASSIP- OA are provided on the 3-5 sessions without having to stress through them. | Week 1,2,3,4,5 |
| Feasibility measure - Fidelity | To ensure good administration of the ASSIP-OA, the investigators use: (1) training manuals with checklists for the therapists to check after each session, and (2) video recordings of randomly selected ASSIP- OA sessions (15%). They are reviewed by independent assessors using a checklist to rate the therapist's competence and adherence to the intervention | Week 1, 2, 3, 4, 5 |
| Sahlgrenska University Hospital | Not yet recruiting | Gothenburg | 41345 | Sweden |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D013406 | Suicide, Attempted |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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