NCT03209544

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
724

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

July 4, 2017

Last Update Submit

July 5, 2017

Conditions

Keywords

Suicidal ideationSuicideCognitive behavioral therapyOnline intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Suicidal Ideation Attributes

    Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline

  • Beck Depression Inventory - second edition

    Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline

  • Beck Hopelessness Scale

    Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline

  • Penn State Worry Questionnaire - Past Week

    Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline

  • Hospital Anxiety and Depression Scale

    Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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).

Also known as: Think Life
Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Suicidal IdeationSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Kees van Heeringen, MD, PhD

    Ghent Univeristy - Flemish Centre for Expertise in Suicide Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 6, 2017

Study Start

April 23, 2015

Primary Completion

December 7, 2015

Study Completion

February 24, 2016

Last Updated

July 6, 2017

Record last verified: 2017-07