Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if adding a digital intervention to standard cognitive-behavioral therapy (CBT) is more effective in preventing suicide risk and reducing eating disorder symptoms. Participants will be women between 18 and 65 years old who have recently experienced suicidal ideation or attempts. One group will receive standard group therapy, while the other will receive group therapy plus a mobile application and digital monitoring devices. The goal is to see if digital tools can improve clinical outcomes and safety for patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) | Experimental |
| |
| Cognitive Behavioural Therapy (CBT) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Behavioral | 8 structured group sessions based on Christopher Fairburn's program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Eating Attitudes Test-26 (EAT-26) Score. | The EAT-26 is a self-report questionnaire used to assess eating disorder risk and symptoms. It consists of 26 items. Total scores range from 0 to 78, where higher scores indicate greater severity of eating disorder symptoms. | Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up. |
| Change from Baseline in Bulimic Investigatory Test Edinburgh (BITE) Score. | The BITE is used to identify individuals with binge-eating and compensatory behaviors. It consists of two subscales: Symptoms (0-30 points) and Severity (0-39 points). We will report the Total Score. Higher scores indicate higher levels of bulimic symptoms. | Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up. |
| Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score. | The C-SSRS Full Scale is a clinical tool used to assess the full spectrum of suicidal ideation and behavior. It consists of two main sections: (1) Suicidal Ideation (A severity scale ranging from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent) and (2) Suicidal Behavior (A scale that tracks the presence of actual, interrupted, or aborted attempts, and preparatory acts rated as Yes/No). For this outcome, we will report the Suicidal Ideation Severity Score. Higher scores indicate a greater severity of suicidal ideation. | Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score. | The PHQ-9 is a 9-item tool used to monitor the severity of depression. Scores range from 0 to 27. Higher scores indicate greater severity of depressive symptoms. | Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Parc Taulà | Recruiting | Sabadell | Barcelona | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) | Behavioral | DigitaI therapy: includes a mobile app with a digital safety plan (warning signs, coping strategies, contact persons, etc.) activated by real-time risk assessments (2-4 random questions daily) |
|
| Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score. |
The GAD-7 is a 7-item scale used to measure the severity of generalized anxiety. Scores range from 0 to 21. Higher scores indicate greater severity of anxiety symptoms. |
| Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up. |