About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
ASSIP-OA
BehavioralASSIP-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 interventionAntidepressant 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 groups
Trial 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.
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.
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.
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.
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.
Other outcomes
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. "
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.
Feasibility measure Acceptability
Acceptability will be addressed in the qualitative interviews with patients post intervention.
Feasibility measure - Appropriatness
Appropriateness is measured by Cronbach alpha and mean inter-item correlation in our questionnaires.
Sponsors and contacts
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Vastra Gotaland Region
Lead sponsor
Göteborg University
Collaborator