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

NCT06831942 | Recruiting

• 2 other identifiers: 2024-07392-012023-00181
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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. 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. 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. 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?

Conditions

Suicidal Ideation; Suicide Attempt; Suicide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Severity of suicidal 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

  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

  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

  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

  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

Other Outcomes (6)

• Therapeutic Alliance

  After the second ASSIP-OA session approx 2 weeks after of study inclusion

• Side effects

  After the last ASSIP-OA session approx 5 weeks after study inclusion

• Feasibility measure Acceptability

  Post intervention approx after 5 weeks

Study Arms (2)

ASSIP-OA

EXPERIMENTAL

The ASSIP-OA intervention and treatment as usual (TAU)

Behavioral: ASSIP-OA

Treatment as Usual

ACTIVE COMPARATOR

Ordinary treatment

Other: Treatment as Usual (TAU)

Interventions

ASSIP-OA BEHAVIORAL

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.

ASSIP-OA

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.

Treatment as Usual

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (2)

Södra Älvsborg Hospital

Borås, 50182, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Suicide

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Margda Waern, Professor

  Department of Psychiatry, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Hed, Phd Student

CONTACT

+46735324985; sara.hed@gu.se

Margda Waern, Professor

CONTACT

margda.waern@neuro.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2031
• Last Updated: November 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)