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
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
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
NCT ID
NCT03209544
First Posted
July 4, 2017
Last Updated
July 5, 2017
Sponsor
University Ghent
Collaborators
VU University of Amsterdam
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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