Clinical trial NCT06831942: Attempted Suicide Short Intervention Program for Older Adults (ASSIP-OA): An Evaluation of a Psychosocial Intervention for Suicidal Adults Aged 65+
Official title: 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+
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicide Attempt
Suicide
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2025-02-18
Enrollment: 132
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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?


Eligibility criteria: 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.

Primary outcomes:
measure: New suicidal episode which includes suicide attempt or death by suicide
timeFrame: Follow-ups at 6, 12 and 24 months
Secondary outcomes:
measure: Severity of suicidal ideation
timeFrame: 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: Depressive symptoms
timeFrame: 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: Anxiety
timeFrame: 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: Coping
timeFrame: 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: Health-related quality of life
timeFrame: 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: Health-care utilization
timeFrame: 12- and 24-month follow-ups.
Other outcomes:
measure: Therapeutic Alliance
timeFrame: After the second ASSIP-OA session approx 2 weeks after of study inclusion
measure: Side effects
timeFrame: After the last ASSIP-OA session approx 5 weeks after study inclusion
measure: Feasibility measure Acceptability
timeFrame: Post intervention approx after 5 weeks
measure: Feasibility measure - Appropriatness
timeFrame: Post intervention (5-weeks) and at follow upp after 6, 12 and 24 months.
measure: Feasibility measure - Deliverability
timeFrame: Week 1,2,3,4,5
measure: Feasibility measure - Fidelity
timeFrame: Week 1, 2, 3, 4, 5
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborg Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Department of Psychiatry, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden
name: Margda Waern, Professor
role: PRINCIPAL_INVESTIGATOR
References: