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Think Life, an Online Self-help Intervention for Coping With Suicidal Ideation

Primary Purpose

Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Online self-help intervention
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicidal ideation, Suicide, Cognitive behavioral therapy, Online intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Have internet access and an e-mail account

Exclusion Criteria:

  • No suicidal thoughts (i.e. baseline score on Beck Scale for Suicide Ideation = 0)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    The intervention group gains access to Think Life, an online self-help intervention. During 6 weeks they receive a new module on a weekly basis.

    Waitlist control group. They receive access to Think Life after 12 weeks.

    Outcomes

    Primary Outcome Measures

    Beck Scale for Suicide Ideation
    Changes in severity of suicidal ideation

    Secondary Outcome Measures

    Suicidal Ideation Attributes
    Changes in severity of suicidal ideation
    Beck Depression Inventory - second edition
    Changes in symptoms and severity of depression
    Beck Hopelessness Scale
    Changes in one's negative attitude towards the future
    Penn State Worry Questionnaire - Past Week
    Changes in degree of worrying
    Hospital Anxiety and Depression Scale
    Changes in anxiety

    Full Information

    First Posted
    July 4, 2017
    Last Updated
    July 5, 2017
    Sponsor
    University Ghent
    Collaborators
    VU University of Amsterdam
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03209544
    Brief Title
    Think Life, an Online Self-help Intervention for Coping With Suicidal Ideation
    Official Title
    A Randomized Controlled Trial on the Effectiveness of an Online Self-help Intervention for Suicidal Ideation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 23, 2015 (Actual)
    Primary Completion Date
    December 7, 2015 (Actual)
    Study Completion Date
    February 24, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Ghent
    Collaborators
    VU University of Amsterdam

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The objective of the Think Life study is to test the effect of an online, unguided self-help intervention, i.e. Think Life. The primary hypothesis is that Think Life will reduce suicidal ideation. The secondary hypothesis is that Think Life will lead to improvements in depressive symptoms, hopelessness, rumination, and anxiety. Positive changes are expected after completing Think Life and at follow-up, twelve weeks after baseline.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation
    Keywords
    Suicidal ideation, Suicide, Cognitive behavioral therapy, Online intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized
    Enrollment
    724 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    The intervention group gains access to Think Life, an online self-help intervention. During 6 weeks they receive a new module on a weekly basis.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Waitlist control group. They receive access to Think Life after 12 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Online self-help intervention
    Other Intervention Name(s)
    Think Life
    Intervention Description
    The intervention was originally developed by van Spijker, van Straten, and Kerkhof (2010). For this study, it was adapted to the Flemish context and called Think Life. Think Life is mainly based Cognitive Behaviour Therapy (CBT). Additionally, it encompasses elements from Dialectical Behaviour Therapy (DBT), Problem Solving Therapy (PST), and Mindfulness Based Cognitive Therapy (MBCT). It encompasses six modules and every module starts with a psycho-educational section followed by a weekly assignment, core exercises and optional exercises. The participant weekly receives access to a new module. A more detailed description of the intervention is described elsewhere (Kerkhof, van Spijker, & Mokkenstorm, 2013; van Spijker et al., 2010; van Spijker, van Straten, et al., 2014).
    Primary Outcome Measure Information:
    Title
    Beck Scale for Suicide Ideation
    Description
    Changes in severity of suicidal ideation
    Time Frame
    Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
    Secondary Outcome Measure Information:
    Title
    Suicidal Ideation Attributes
    Description
    Changes in severity of suicidal ideation
    Time Frame
    Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
    Title
    Beck Depression Inventory - second edition
    Description
    Changes in symptoms and severity of depression
    Time Frame
    Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
    Title
    Beck Hopelessness Scale
    Description
    Changes in one's negative attitude towards the future
    Time Frame
    Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
    Title
    Penn State Worry Questionnaire - Past Week
    Description
    Changes in degree of worrying
    Time Frame
    Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
    Title
    Hospital Anxiety and Depression Scale
    Description
    Changes in anxiety
    Time Frame
    Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years or older Have internet access and an e-mail account Exclusion Criteria: No suicidal thoughts (i.e. baseline score on Beck Scale for Suicide Ideation = 0)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kees van Heeringen, MD, PhD
    Organizational Affiliation
    Ghent Univeristy - Flemish Centre for Expertise in Suicide Prevention
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Think Life, an Online Self-help Intervention for Coping With Suicidal Ideation

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