Suicidal IdeationNCT03209544
Think Life, an Online Self-help Intervention for Coping With Suicidal Ideation
A study testing Online self-help intervention in people with Suicidal Ideation, run by University Ghent.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Online self-help intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 724 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2015to 24 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Have internet access and an e-mail account
Who cannot join
- No suicidal thoughts (i.e. baseline score on Beck Scale for Suicide Ideation = 0)
About this study
Official title: 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.
- Conditions
- Suicidal Ideation
- Being tested
- Online self-help intervention
- Keywords
- Suicidal ideation, Suicide, Cognitive behavioral therapy, Online intervention
- Medical subject headings
- Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-help interventionBehavioural
Also called Think Life
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online self-help intervention |
| Control group | No intervention | Waitlist control group. They receive access to Think Life after 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Scale for Suicide Ideation
Changes in severity of suicidal ideation
Measured: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
Secondary outcomes (5)
Suicidal Ideation Attributes
Changes in severity of suicidal ideation
Measured: 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
Measured: 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
Measured: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Penn State Worry Questionnaire - Past Week
Changes in degree of worrying
Measured: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Hospital Anxiety and Depression Scale
Changes in anxiety
Measured: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start23 Apr 2015
- Primary completion7 Dec 2015
- Study completion24 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Sponsor
- Investigators
- Kees van Heeringen, MD, PhD, Principal investigator, Ghent Univeristy - Flemish Centre for Expertise in Suicide Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209544
- Sponsor's protocol ID
- 2014/1050
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effectiveness of an Online Self-help Intervention for Suicidal Ideation
- ClinicalTrials.gov ID
- NCT03209544
- Acronym / sponsor ID
- 2014/1050
- Conditions
- Suicidal Ideation
- Keywords
- Suicidal ideation, Suicide, Cognitive behavioral therapy, Online intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- 23 Apr 2015 (actual)
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 24 Feb 2016 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Online self-help interventionThe intervention group gains access to Think Life, an online self-help intervention. During 6 weeks they receive a new module on a weekly basis. |
| Control group | No intervention | –Waitlist control group. They receive access to Think Life after 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Have internet access and an e-mail account
Key exclusion criteria (1 listed)
- No suicidal thoughts (i.e. baseline score on Beck Scale for Suicide Ideation = 0)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online self-help interventionAlso: Think LifeThe 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). | Behavioural | Intervention group |
Primary outcome
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
5 secondary outcomes
Suicidal Ideation Attributes
Time frame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
Beck Depression Inventory - second edition
Time frame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
Beck Hopelessness Scale
Time frame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Penn State Worry Questionnaire - Past Week
Time frame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Hospital Anxiety and Depression Scale
Time frame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kees van Heeringen, MD, PhD principal investigator
Ghent Univeristy - Flemish Centre for Expertise in Suicide Prevention
Questions about this trial
What is this clinical trial studying?
A study testing Online self-help intervention in people with Suicidal Ideation, run by University Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Scale for Suicide Ideation (time frame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.