Safety Intervention for Improving Functioning in Suicidal Attempters

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the effectiveness of a safety planning intervention in suicidal attempters by improving their psychosocial functional outcome and therefore enhancing their ability to perform the activities of daily living. As secondary objectives, assessment of the effectiveness of a safety planning intervention in suicidal attempters will be performed by determining cognitive performance (particularly decision-making, inhibition and attention), quality of life, clinical state and relating all these data with neuroimaging correlates. Target neuroimaging areas will be the orbitofrontal cortex and dorsal prefrontal cortex.

Detailed Description
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Design: STRONG is a single-centre experimental randomized clinical trial for suicidal attempters involving a safety planning intervention and 3- to 6-months follow-ups. This study will be carried out in the Bipolar and Depressive Disorders Unit, at Hospital Clínic de Barcelona. It will be rater-blinded and will include two parallel arms (1:1) in order to assess the efficacy of a safety planning intervention compared with treatment as usual. This project has been approved by the Ethical Committee of the Hospital Clinic of Barcelona and it will be carried up in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice in compliance with the data protection law in force and anonymization of the collected information. Procedures: Subsequent to signing the informed consent, a complete baseline evaluation will be carried out which includes acquisition of socio-demographic and clinical variables, psychosocial functioning, cognitive performance, quality of life assessment and neuroimaging determinations (v0). Thereafter, the whole sample will be randomized in two groups of 60 participants by parallel assignment. A group of 60 people will exclusively receive treatment as usual (non-intervention group); whereas the other group of 60 participants will receive a safety planning intervention in addition to their treatment as usual (experimental group). After two months of finishing the intervention of 4 weeks (or three months after baseline), suicidal attempters will be reassessed from a socio-demographic, clinical, psychosocial functioning, quality of life assessment as well as brief neuropsychological evaluation (v1). The neuropsychological assessment in this point will be shorter to avoid learning effect. Five months after intervention (or 6-months after baseline), a completely socio-demographic, clinical psychosocial functioning, quality of life assessment as well as neuropsychological and neuroimaging evaluation will be carried out (v2). Assessments: A) Socio-demographic variables: Information on gender, age, marital status, current type of cohabitation, number of offspring (if any), educational level, years of education, employment status and socioeconomic status. B) Clinical, psychosocial functioning, quality of life evaluation: Suicidal ideation and behaviour, clinical symptomatology, in general and depressive symptoms and anxiety symptoms in particular, lifetime history of psychiatric or medical comorbidities, diagnosis, number of hospitalizations, family history of affective and psychiatric disorders, and pharmacological treatment will be collected for all subjects, premorbid adjustment, psychosocial functioning, quality of life, impulsiveness, reflective functioning and stress associated with life events will be also assessed using standardized questionnaires. Clinical variables will be assessed at baseline, two months post-intervention and at the 6-month follow-up. C) Neuropsychological assessment: Intelligence quotient, attention, processing speed, verbal and visual memory, working memory, and executive functions will be assessed in all subjects. The extended neuropsychological battery will be administered at baseline and at 6 months. To avoid learning effects, only some of the tests evaluating attention and executive functions will be administered in the 2-month assessment post-intervention. D) Neuroimaging assessment: Magnetic resonance imaging (MRI) will be performed at baseline, and in the 6-month follow-up. Data acquisition will be performed using a full-body MRI scanner, a Siemens Magnetom Prisma 3 Teslas. A part from structural T1, resting-state functional MRI, and diffusion-weighted imaging, two tasks related to decision making and inhibition will be carried out. Non-contrast MRI will be used. Participants will not be exposed to radiation.

Official Title
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Safety Intervention for Improving Functioning in Suicidal Attempters

Conditions
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Suicide, Attempted, Functioning, Psychosocial

Intervention / Treatment
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* Behavioral: Safety Intervention Planning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old Having attempted suicide Provide written informed consent No claustrophobia/metallic objects/implants Exclusion Criteria: Intelligence quotient below 70 and impaired functioning Any medical condition that could affect neuropsychological performance (such as neurological diseases) or a history of head trauma with loss of consciousness Participation in any structured psychological intervention within the past 6 months Patients who received electroconvulsive therapy within the past 6 months Inability to give inform consent

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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Accepts Healthy Volunteers

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: Experimental randomized clinical study. Rater-blinded. Sample: Suicidal attempters.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment As Usual<br>(TAU) | |
| Experimental: Intervention Group<br>Treatment As Usual + Safety Intervention Planning. | Behavioral: Safety Intervention Planning<br>* The therapy is based on the iFightDepression platform implemented by the European Alliance against Depression. The aim of this specific therapy is to help individuals to acquire strategies to regulate emotions and learn to tolerate discomfort preventing the imminent risk for suicidal behavior. The safety planning intervention will be conducted by identifying warning signs and provide each individual with personal and individualized coping strategies and sources of support. Main skills to be acquired and integrated for the individual are as it follows: 1) Contingency plan by five steps (identification of warning signs; applying internal coping strategies; network as distraction; safe environment; reasons for living and contact professionals), 2) Mindfulness, 3) Discomfort tolerance, and 4) Regulating emotions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial functioning changes in Functioning Assessment Short Test (FAST). | Suicidal attempters receiving a safety planning intervention will show a decrease in FAST scores, compared to those suicidal attempters receiving treatment as usual. Lower general scores on this scale indicate better psychosocial functioning. | 2 months after intervention; 5 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive changes in executive functions, specifically in decision-making measured by Iowa Gambling Task (IGT). | Suicidal attempters receiving a safety planning intervention will experience greater improvement in cognitive performance, particularly in decision-making compared to those suicidal attempters receiving treatment as usual. A proxy of decision-making ability is extracted by means of a formula taking into account number of safe choices minus risky selections in terms of alll choices during the task. Higher scores are related to better decision-making ability. Normative data has been published for Spanish population and will be used to assess improvement based on the baseline visit (vs. performance 6-month follow-up). | 2 months after intervention; 5 months after intervention | 
| Cognitive changes in executive functions, specifically in impulsivity measured by Stroop Test (Stroop). | Suicidal attempters receiving a safety planning intervention will experience greater improvement in cognitive performance, particularly in inhibition compared to those suicidal attempters receiving treatment as usual. Inhibitory control will be assessed by measure of interference obtained through Stroop test. Higher scores here mean better inhibitory control, thus less impulsivity. Normative data are taken from the original version of Stroop Test and will be used to assess improvement based on the baseline visit (vs. performance 6-month follow-up). | 2 months after intervention; 5 months after intervention | 
| Cognitive changes in executive functions, specifically in attention measured by Conners' Performance Test v.5 (CPT-II). | Suicidal attempters receiving a safety planning intervention will experience greater improvement in cognitive performance, particularly in attention, compared to those suicidal attempters receiving treatment as usual. Measures used to assess inattention include: omissions, commissions, Hit Reaction Time (RT), Detectability (d'), Hit RT Block Change and Hit RT Inter-Stimulus Intervals (ISI) Change by means of CPT-II. All measures taken together provide an index of inattention, which is based on T-scores. In this test, higher scores reflect greater impairment. Normative data has been published in CPT II V.5 and will be used to assess improvement based on the baseline visit (vs. performance 6-month follow-up). | 2 months after intervention; 5 months after intervention | 
| Changes in self-reported quality of life by Quality of Life 5-Dimensions scale (EuroQoL-5D). | Suicidal attempters receiving a safety planning intervention will show greater improvement in quality of life compared to those suicidal attempters receiving treatment as usual taking into account baseline measures self-reported in comparison with the following visits. This scale comprises two subscales: First subscale measures quality of life using a descriptive system by dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression). The higher the score here, the worse the quality of life. Second subscale uses a visual analog scale from 0 to 100 for self-reporting overall quality of life. Higher scores here reflect better quality of life. All items refer to the current day. | 2 months after intervention; 5 months after intervention | 
| Clinical changes in suicidal behavior assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). | Suicidal attempters receiving a safety planning intervention will not show suicidal behavior measured by C-SSRS in the two follow-up visits after intervention with Safety Planning Intervention (SPI) compared to those suicidal attempters receiving treatment as usual. | 2 months after intervention; 5 months after intervention | 
| Clinical changes in depressive symptomatology assessed by Patient Health Questionnaire (PHQ-9). | Patient Health Questionnaire (PHQ-9) measures frequence of depressive symptoms occurrence. Lower scores show less depressive-related symptomatology. PHQ-9 scores following intervention are expected to be lower than at baseline. | 2 months after intervention; 5 months after intervention | 
| Clinical changes in anxious symptomatology assessed by Generalized Anxiety Disorder (GAD-7). | Generalized Anxiety Disorder (GAD-7) measures frequence of anxious symptoms occurrence. Lower scores show less anxiety-related symptomatology. GAD-7 scores following intervention are expected to be lower than at baseline. | 2 months after intervention; 5 months after intervention | 
| Changes in activation of different areas of the prefrontal cortex measured by functional Magnetic Resonance Imagining (fMRI). | Suicidal attempters receiving a safety planning intervention will show changes in different areas of the prefrontal cortex. Changes expected include resting and activation conditions. We expect to detect more activation in prefrontal cortex (PFC) areas such as the ventrolateral PFC (including the orbitofrontal cortex), the anterior cingulate gyrus, the dorsomedial PFC and the dorsolateral PFC in patients receiving psychological intervention (in comparison with their baseline performance in task-related fMRI). Other areas such as the amygdala and medial temporal cortex will also be explored. Additionally, alterations in white matter connections measures by Diffusion Weighted Imaging (DWI) and Diffusion Tensor Imagining (DTI) will be assessed at baseline and will be compared with 6-months follow up imaging acquisition. Moreover, possible anatomical changes in prefrontal cortex areas will be also assessed. | 5 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suicide, cognition, neuroimaging, psychosocial functioning, quality of life