A Future-oriented Group Training for Suicidal Patients

Study Overview
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Brief Summary
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The main goal of this study is to evaluate the effectiveness of a Future-oriented Group training aimed at reducing suicidality in adults. This will test the effectiveness by studying the effect on suicidal ideation and related outcomes, compared to Treatment As Usual. Participants will also be asked to evaluate the group training. The study is a multicentre randomized controlled trial conducted in out-patient Flemish mental healthcare facilities.

Official Title
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Randomized Controlled Trial Investigating the Effectiveness of Future-oriented Group Training for Suicidal Patients

Conditions
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Suicidal Ideation, Suicide Attempt

Intervention / Treatment
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* Behavioral: Future Oriented Group Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Speak Dutch Be at least 18 years old Have access to internet Be suitable for group therapy Have mild to severe suicidal thoughts (BSS score of minimum 1) Exclusion Criteria: Conditions expected to severely hinder group participation, comprehension of the training content or adherence

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial comparing an experimental condition (Treatment As Usual + Future Oriented Group Training) and a control condition (Treatment As Usual)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants in the intervention group received Future Oriented Group Training in addition to their treatment as usual. | Behavioral: Future Oriented Group Training<br>* This study's experimental condition consisted of a Future Oriented Group Training (FOGT), originally developed in 2008 by van Beek et al. (2009). Participants followed this training weekly, over a period of 9 weeks in groups of 6 to 10 participants. The sessions, which lasted one and a half hours each, were each led by one trainer.<br>|
| No Intervention: Control Group<br>Participants in the control group received their treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal ideation: The Beck Scale for Suicide Ideation | A 21-item self-report questionnaire to measure (the severity of) suicidal ideation in adolescents and adults. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38, with higher scores indicating more (severe) suicidal ideation. | Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms: The second edition of the Beck Depression Inventory | A 21-item self-report questionnaire to measure depressive symptoms and attitudes in the past week. Each item is rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 63, with higher scores indicating more depressive symptoms. | Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention) | 
| Hopelessness: The Beck Hopelessness Scale | A 20-item self-report questionnaire to measure hopelessness in adolescents and adults. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 20, with higher scores indicating higher levels of hopelessness. | Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention) | 
| Defeat: the Defeat Scale | A 16-item self-report questionnaire to measure defeat on a five-point Likert scale. | Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention) | 
| Entrapment: the Entrapment Scale | A 16-item self-report questionnaire to measure entrapment on a five-point Likert scale. | Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention) | 
| Worrying: The Penn State Worry Questionnaire - past week | A 15-item self-report questionnaire to measure worrying in the past week. Each item is rated on a 7-point Likert scale ranging from 0 (never) to 6 (almost always). | Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention) | 
| Future-oriented thinking | A 22-item self-report questionnaire to measure repeated thinking about the future, specifically about the likelihood of negative and positive events happening. Each item is rated on a 4-point Likert scale ranging from 0 (never) to 3 (almost always). | Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention) |