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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209544
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
University Ghent

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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Behavioral: Online self-help intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 724 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on the Effectiveness of an Online Self-help Intervention for Suicidal Ideation
Actual Study Start Date : April 23, 2015
Actual Primary Completion Date : December 7, 2015
Actual Study Completion Date : February 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Intervention group
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.
Behavioral: Online self-help intervention
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).
Other Name: Think Life

No Intervention: Control group
Waitlist control group. They receive access to Think Life after 12 weeks.



Primary Outcome Measures :
  1. Beck Scale for Suicide Ideation [ Time Frame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline ]
    Changes in severity of suicidal ideation


Secondary Outcome Measures :
  1. Suicidal Ideation Attributes [ Time Frame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline ]
    Changes in severity of suicidal ideation

  2. Beck Depression Inventory - second edition [ Time Frame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline ]
    Changes in symptoms and severity of depression

  3. Beck Hopelessness Scale [ Time Frame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline ]
    Changes in one's negative attitude towards the future

  4. Penn State Worry Questionnaire - Past Week [ Time Frame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline ]
    Changes in degree of worrying

  5. Hospital Anxiety and Depression Scale [ Time Frame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline ]
    Changes in anxiety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209544


Sponsors and Collaborators
University Ghent
VU University of Amsterdam
Investigators
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Principal Investigator: Kees van Heeringen, MD, PhD Ghent Univeristy - Flemish Centre for Expertise in Suicide Prevention
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03209544    
Other Study ID Numbers: 2014/1050
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
Suicidal ideation
Suicide
Cognitive behavioral therapy
Online intervention
Additional relevant MeSH terms:
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Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms