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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209544
Other study ID # 2014/1050
Secondary ID
Status Completed
Phase N/A
First received July 4, 2017
Last updated July 5, 2017
Start date April 23, 2015
Est. completion date February 24, 2016

Study information

Verified date July 2017
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 724
Est. completion date February 24, 2016
Est. primary completion date December 7, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University Ghent VU University of Amsterdam

Outcome

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