Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: MYPLAN - Effectiveness of a Safety Plan App to Manage Crisis of Persons at Risk of Suicide - a Multi-center, Superiority Randomized Clinical Trial
Brief Summary: Background: Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time. Safety plans in paper format are mandatory part of the treatment regime in the suicide preventive clinics in Denmark. The aim of the trial is to compare the paper version of the safety plan with a new-developed app in reducing suicide ideation and other symptoms, as an add-on to the supportive psychotherapy delivered in the clinics.

Hypothesis: It is hypothesized that participants randomized to MYPLAN will have lower suicide ideation as well as improvements on the secondary outcomes than users who have the paper version.

Methods: The trial is designed as a 2-arm observer-blinded parallel group randomized clinical superiority trial, where participants will either receive: 1) Experimental intervention: the safety plan provided as the app MYPLAN, or 2) Treatment as Usual: the safety plan in the original paper format. Both intervention groups will also receive standard psychosocial therapeutic care, up to 8-10 sessions of supportive psychotherapy.Based on a power calculation a total of 546 participants, 273 in each arm will be included. They will be recruited from national suicide preventive clinics. Follow-ups will be conducted at 3, 6, 9, and 12 months after date of inclusion.

Participants, inclusion and exclusion criteria: There is no age restriction on participation in the study and all participants will be recruited from the suicide prevention clinics in Denmark. These clinics are highly specialized outpatient care centers, offering short-term supportive psychotherapy and social counselling for suicidal patients. In order to participate in the study, participants must have a smartphone (IPhone or android phone) and understand sufficient Danish to use MYPLAN. Persons having a particularly severe alcohol or substance abuse disorder, which might inflict with skills of orientation and memorywill not be offered participation in the RCT.

Outcomes Patient reported outcomes (PROM) are collected at baseline and follow-up through self-administered tablet/internet-based questionnaires. Primary outcome is suicide ideation. Secondary outcomes are:, hopelessness, depressive symptoms, quality of life, and modified CSQ-8.

Statistical analysis: Data analysis will be based on intention-to-treat principle. We will examine this using repeated measurement in mixed models. Missing data will be handled with multiple imputations.

The trial will start in November 2016 and patient recruitment is expected to finish November 2017. Analysis and results are expected in 2018.


Options:
A: Arm Label: Psychosocial group intervention; Type: EXPERIMENTAL; Interventions: Behavioral: 10 weekly group meetings, Behavioral: Outpatient counseling and support groups | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Outpatient counseling and support groups | Intervention Type: BEHAVIORAL; Name: 10 weekly group meetings; Assigned to Arm(s): Psychosocial group intervention | Intervention Type: BEHAVIORAL; Name: Outpatient counseling and support groups; Assigned to Arm(s): Control, Psychosocial group intervention
B: Arm Label: MYPLAN app; Type: EXPERIMENTAL; Interventions: Other: MYPLAN-safety plan as an application for smart phones | Arm Label: Safety plan on paper; Type: ACTIVE_COMPARATOR; Interventions: Other: safety plan on paper | Intervention Type: OTHER; Name: MYPLAN-safety plan as an application for smart phones; Assigned to Arm(s): MYPLAN app | Intervention Type: OTHER; Name: safety plan on paper; Assigned to Arm(s): Safety plan on paper
C: Arm Label: Standard DBT + PTSD Protocol; Type: EXPERIMENTAL; Interventions: Behavioral: Dialectical Behavior Therapy, Behavioral: PTSD Protocol | Arm Label: Standard DBT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Dialectical Behavior Therapy | Intervention Type: BEHAVIORAL; Name: Dialectical Behavior Therapy; Assigned to Arm(s): Standard DBT, Standard DBT + PTSD Protocol | Intervention Type: BEHAVIORAL; Name: PTSD Protocol; Assigned to Arm(s): Standard DBT + PTSD Protocol
D: Arm Label: Youth-Nominated Support Team; Type: EXPERIMENTAL; Interventions: Behavioral: Youth-Nominated Support Team | Arm Label: Enhanced Treatment as Usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Youth-Nominated Support Team; Assigned to Arm(s): Youth-Nominated Support Team

Answer: B