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

A Randomized Controlled Trial on the Effectiveness of an Online Self-help Intervention for Suicidal Ideation

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation
• Intervention / Treatment: Behavioral: Online self-help intervention

• Study Type: Interventional
• Enrollment (Actual): 724
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Think Life
NO_INTERVENTION: Control group; Waitlist control group. They receive access to Think Life after 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Scale for Suicide Ideation	Changes in severity of suicidal ideation	Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal Ideation Attributes	Changes in severity of suicidal ideation	Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
Beck Depression Inventory - second edition	Changes in symptoms and severity of depression	Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
Beck Hopelessness Scale	Changes in one's negative attitude towards the future	Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Penn State Worry Questionnaire - Past Week	Changes in degree of worrying	Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Hospital Anxiety and Depression Scale	Changes in anxiety	Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: VU University of Amsterdam
• Investigators: Principal Investigator: Kees van Heeringen, MD, PhD, Ghent Univeristy - Flemish Centre for Expertise in Suicide Prevention

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2015
• Primary Completion (ACTUAL): December 7, 2015
• Study Completion (ACTUAL): February 24, 2016

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (ACTUAL): July 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Suicide; Suicidal ideation; Online intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 2014/1050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No