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

N/ARecruitingNCT06831942

Vastra Gotaland Region132 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

ASSIP-OABEHAVIORAL

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.

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Follow-ups at 6, 12 and 24 months

Secondary Outcomes

Severity of suicidal ideation

Columbia-Suicide Severity Rating Scale (C-SSRS) Scores range from 0-5, where higher scores indicate more severe ideation.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12- and 24-month follow-ups.

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts