MYPLAN - Effectiveness of a Safety Plan App to Manage Crisis of Persons at Risk of Suicide

NCT02877316 | Completed DMC

• 1 other identifier: MHSCRDenmark
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 4

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.

Conditions

Suicide Prevention; Suicidal Thoughts; Suicide Attempts

Outcome Measures

Primary Outcomes (1)

• Suicide ideation

  Primary outcome will be measured as the difference in suicide ideation before entering the trial and after 6 month participation in the trial. This is measured by Becks suicide ideation scale (BSS 21-items).

  12 month

Secondary Outcomes (2)

• Depressiv symptoms

  12 month

• Hopelessness

  12 month

Other Outcomes (2)

• Quality of life index

  12 month (Baseline, 3 month,

• Satisfaction of the app

  12 month

Study Arms (2)

MYPLAN app

EXPERIMENTAL

MYPLAN app (safety plan) as part of treatment

Other: MYPLAN-safety plan as an application for smart phones

Safety plan on paper

ACTIVE COMPARATOR

Safety plan on paper as part of treatment

Other: safety plan on paper

Interventions

MYPLAN-safety plan as an application for smart phones OTHER

MYPLAN app as a integral part of the standard treatment

MYPLAN app

safety plan on paper OTHER

Standard treatment with safety plan on paper

Safety plan on paper

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Smart phone (Iphone/android)
• Understand sufficient Danish to use MYPLAN
• Informed written consent

You may not qualify if:

• Alcohol or substance abuse disorder (DSM-V)

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (4)

Psychiatric centre Ballerup, Clinic for psychoterapy

Ballerup Municipality, Denmark

Location

Competence centre for suicide prevention

Copenhagen, Denmark

Location

Psychiatric Centre North Zealand

Hillerød, Denmark

Location

Clinic for suicide prevention

Køge, Denmark

Location

Related Publications (7)

• Christiansen E, Jensen BF. Register for Suicide Attempts. Dan Med Bull. 2004 Nov;51(4):415-7.

  PMID: 16009065 BACKGROUND

• Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.

  PMID: 16077050 BACKGROUND

• Stanley B, Brown G, Brent DA, Wells K, Poling K, Curry J, Kennard BD, Wagner A, Cwik MF, Klomek AB, Goldstein T, Vitiello B, Barnett S, Daniel S, Hughes J. Cognitive-behavioral therapy for suicide prevention (CBT-SP): treatment model, feasibility, and acceptability. J Am Acad Child Adolesc Psychiatry. 2009 Oct;48(10):1005-1013. doi: 10.1097/CHI.0b013e3181b5dbfe.

  PMID: 19730273 BACKGROUND

• Yanos PT, Stanley BS, Greene CS. Research risk for persons with psychiatric disorders: a decisional framework to meet the ethical challenge. Psychiatr Serv. 2009 Mar;60(3):374-83. doi: 10.1176/ps.2009.60.3.374.

  PMID: 19252051 BACKGROUND

• Erlangsen A, Lind BD, Stuart EA, Qin P, Stenager E, Larsen KJ, Wang AG, Hvid M, Nielsen AC, Pedersen CM, Winslov JH, Langhoff C, Muhlmann C, Nordentoft M. Short-term and long-term effects of psychosocial therapy for people after deliberate self-harm: a register-based, nationwide multicentre study using propensity score matching. Lancet Psychiatry. 2015 Jan;2(1):49-58. doi: 10.1016/S2215-0366(14)00083-2. Epub 2015 Jan 8.

  PMID: 26359612 BACKGROUND

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.

  PMID: 33677832 DERIVED

• Andreasson K, Krogh J, Bech P, Frandsen H, Buus N, Stanley B, Kerkhof A, Nordentoft M, Erlangsen A. MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):171. doi: 10.1186/s13063-017-1876-9.

  PMID: 28399909 DERIVED

Related Links

• Ref. 5. Cognitive therapy for suicidal patients
• Ref 7. Why people die by suicide
• Ref. 9. Diagnostic and statistical manual of mental health disorders

MeSH Terms

Conditions

Suicide Prevention; Suicidal Ideation; Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Merete Nordentoft, MD, Ph.D MSc

  Mental Health Center Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, postdoctoral researcher

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 24, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

DK (4)