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

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+

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?

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Suicide; Suicide Attempt
• Intervention / Treatment: Behavioral: ASSIP-OA; Other: Treatment as Usual (TAU)

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Hed, Phd Student; Phone Number: +46735324985; Email: sara.hed@gu.se
• Study Contact Backup: Name: Margda Waern, Professor; Email: margda.waern@neuro.gu.se

Study Locations

• Sweden
  • Borås, Sweden, 50182
    • Recruiting
    • Södra Älvsborg Hospital
    • Contact: Carina Forsberg; Phone Number: +4676-940 29 47; Email: carina.forsberg@vgregion.se
  • Gothenburg, Sweden, 41345
    • Not yet recruiting
    • Sahlgrenska University Hospital
    • Contact: Sara Hed; Phone Number: +46735324985; Email: sara.hed@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. 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).
3. Terminal illness.
4. Insufficient knowledge of the Swedish language (requires interpreter).
5. Aphasia or other severe communication issue or severe hearing and/or severe visual impairment that render the intervention unfeasible despite corrective aids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASSIP-OA; The ASSIP-OA intervention and treatment as usual (TAU)	Behavioral: 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 suicidal crisis.; Fourth session. An optional extra session to further train safety strategies.; Fifth session (optional). Includes one or two close relatives or other support person(s), chosen by the participant. The session focus on how safety measures learned in in ASSIP-OA can be translated into everyday life.; Standardized letters. therapists will send standardized letters every third month during the first year and biannually during the second year.
Active Comparator: Treatment as Usual; Ordinary treatment	Other: 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 specifically for suicidal older adults are offered as part of ordinary treatment at the participating clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.
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.

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Göteborg University
• Investigators: Principal Investigator: Margda Waern, Professor, Department of Psychiatry, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide; Suicidal Ideation; Suicide, Attempted; Therapeutics
• Other Study ID Numbers: 2024-07392-01; 2023-00181 (Other Grant/Funding Number: FORTE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No