Psychoeducational Course for Suicide Prevention

NCT06466356 | Recruiting

• 1 other identifier: 142708
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for increased suicide risk. The course culminates in working on completing a individual safety plan to prevent an future increase in suicide risk. The course will incorporate both patients and their next of kin. The psychoeducational course will be compared to a control group where the patients receive one individual session with focus on a safety plan to evaluate the intervention. Both groups will receive treatment as usual (TAU) during both the acute phase and follow-up. The study will be conducted as a randomized controlled trial.

Conditions

Suicide Prevention; Suicide Threat; Self Efficacy; Stress, Psychological; Psychiatric Emergency; Psychiatric Disorder

Keywords

Psychoeducation; Safety plan; Gatekeeper; Suicidal crisis syndrome

Outcome Measures

Primary Outcomes (1)

• Self efficacy

  The General self-efficacy scale (GSE) measures optimistic self-beliefs in coping with the demands, tasks and challenges of life in general. It consists of 10 statements that respondents rate on a scale from 1 (not at all true) to 4 (exactly true). The individual's scores on each item are summed up to a GSE score with higher scores indicating higher GSE. Questions regarding the perceived efficacy regarding handling future episodes of increased suicide is added. An increase of ≥ 5 points on the GSE scale is considered the limit for a minimally clinically important change.

  Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.

Secondary Outcomes (9)

• Mental pain

  Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.

• Symptoms of depression

  Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.

• Symptoms of anxiety

  Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.

• Numbers of suicide attempts

  At 6, 12, 24 and 60 months after the completion of the course/individual sessions.

• Numbers of suicides

  At 6, 12, 24 and 60 months after the completion of the course/individual sessions.

Study Arms (2)

Psychoeducational group therapy

EXPERIMENTAL

Group therapy session, 3 meetings. Each group includes 8-10 participant to receive a group based psychoeducative intervention (three for patients, one for next of kin) and TAU.

Other: Psychoeducational Course for Suicide Prevention; Other: Treatment as usual

Individual therapy session

ACTIVE COMPARATOR

The participants in the control group receive one individual therapy session with focus on suicide risk and safety plan with a psychologist or physician and TAU

Other: Individual therapy session; Other: Treatment as usual

Interventions

Psychoeducational Course for Suicide Prevention OTHER

Baseline variables includes diagnosis using ICD-10 criteria for research and demographic variables such as age, sex, level of education and occupation. Following assessments will be used when including patients for the project: The General self-efficacy scale (GSE) with additional questions related to the theme of the psychoeducational topics, The mental pain questionnaire (MPQ, Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT) The Patient Health Questionnaire (PHQ-9), GAD-7, The SCS-Checklist and SCI-5. GSE, MPQ and PHQ-9 will be measured after intervention and after 6, 12, 24 and 60 months.

Psychoeducational group therapy

Individual therapy session OTHER

Baseline variables includes diagnosis using ICD-10 criteria for research and demographic variables such as age, sex, level of education and occupation. Following assessments will be used when including patients for the project: The General self-efficacy scale (GSE) with additional questions related to the theme of the psychoeducational topics, The mental pain questionnaire (MPQ, Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT) The Patient Health Questionnaire (PHQ-9), GAD-7, The SCS-Checklist and SCI-5. GSE, MPQ and PHQ-9 will be measured after intervention and after 6, 12, 24 and 60 months.

Individual therapy session

Treatment as usual OTHER

Treatment as usual (TAU) may include the use of psychotropic drugs, in and out-patient treatment, occupational therapy and other interventions the patients physician deem necessary.

Individual therapy session; Psychoeducational group therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a suicide attempt, suicidal behavior, or risk of suicidal behavior and a clinician evaluating that the patient has an intention to die
• Patients with a suicide attempt or suicidal behavior defined as "a self-inflicted, potentially injurious behavior with a non-fatal outcome for which there is evidence of intention of death and/or considered to have had or been close to a suicidal crisis syndrome.

You may not qualify if:

• Not being sufficiently fluent in Norwegian to provide informed consent, valid responses on psychometric testing or to benefit from a psychoeducative course.
• A known diagnosis of ICD-10 F 60.3 (borderline personality disorder) with similar symptoms at previous admittances.
• Ongoing psychosis.
• A substance abuse condition to such a degree that they are unable to comply with the protocol and are considered to be at risk when attending psychoeducational courses.
• Organic brain disorders or mental disabilities in such a degree that they are unable to comply with the protocol.
• Not being able to give an informed consent

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Helse Nord-Trøndelag HF: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (2)

Helse Nord-Trøndelag

Levanger, Trøndelag, 7600, Norway

RECRUITING

St. Olav Hospital

Trondheim, Trøndelag, 7006, Norway

RECRUITING

MeSH Terms

Conditions

Suicide Prevention; Stress, Psychological; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Katrine K Fjukstad, PhD

  Helse Nord Trøndelag

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrine K Fjukstad, PhD

CONTACT

+4774098600; katrine.k.fjukstad@ntnu.no

Thine Rishaug, MD

CONTACT

Thine.Marita.Kirkeby.Rishaug@stolav.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient and treating clinician will be unblinded to treatment modality. To compensate for lack of blinding concerning the received treatment, the persons ratings, subsequent measurements and data collection at follow-up will be blinded to the treatment conditions to avoid confirmation bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients acutely admitted to Department of acute psychiatry, St Olav University Hospital (SOH) or Levanger Hospital or acutely admitted to an outpatient team for acute and emergency psychiatry, SOH, or admitted to a district psychiatric centers (DPS) in Trøndelag county or evaluated by physicians or psychologists at the Consultation Liaison, SOH. Patients will be included with consecutive sampling of patients who meet the selection criteria and give an informed consent. Participants will be equally randomized (1:1) in the intervention and control group and randomization will take place by digital randomization using WebCRF (KlinForsk/ Klinisk forskningsenhet Midt-Norge). Stratified randomization will be used regarding the baseline variable "substance abuse", ensuring that this variable is more evenly distributed between the two groups than chance.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 20, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

NO (2)