NCT05158946

Brief Summary

The main goal of this study is to evaluate the effectiveness of a Future-oriented Group training aimed at reducing suicidality in adults. This will test the effectiveness by studying the effect on suicidal ideation and related outcomes, compared to Treatment As Usual. Participants will also be asked to evaluate the group training. The study is a multicentre randomized controlled trial conducted in out-patient Flemish mental healthcare facilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

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

December 8, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

December 2, 2021

Last Update Submit

December 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suicidal ideation: The Beck Scale for Suicide Ideation

    A 21-item self-report questionnaire to measure (the severity of) suicidal ideation in adolescents and adults. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38, with higher scores indicating more (severe) suicidal ideation.

    Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention)

Secondary Outcomes (6)

  • Depressive symptoms: The second edition of the Beck Depression Inventory

    Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention)

  • Hopelessness: The Beck Hopelessness Scale

    Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention)

  • Defeat: the Defeat Scale

    Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention)

  • Entrapment: the Entrapment Scale

    Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention)

  • Worrying: The Penn State Worry Questionnaire - past week

    Baseline (2 weeks before the intervention), posttest (9 weeks after start of intervention), follow-up (3 months after the end of the intervention)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Treatment evaluation

    Posttest (9 weeks after start of intervention)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group received Future Oriented Group Training in addition to their treatment as usual.

Behavioral: Future Oriented Group Training

Control Group

NO INTERVENTION

Participants in the control group received their treatment as usual.

Interventions

This study's experimental condition consisted of a Future Oriented Group Training (FOGT), originally developed in 2008 by van Beek et al. (2009). Participants followed this training weekly, over a period of 9 weeks in groups of 6 to 10 participants. The sessions, which lasted one and a half hours each, were each led by one trainer.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Speak Dutch
  • Be at least 18 years old
  • Have access to internet
  • Be suitable for group therapy
  • Have mild to severe suicidal thoughts (BSS score of minimum 1)

You may not qualify if:

  • Conditions expected to severely hinder group participation, comprehension of the training content or adherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Suicide Research, Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Suicidal IdeationSuicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Gwendolyn Portzky

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial comparing an experimental condition (Treatment As Usual + Future Oriented Group Training) and a control condition (Treatment As Usual)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 15, 2021

Study Start

December 8, 2016

Primary Completion

November 21, 2017

Study Completion

May 31, 2018

Last Updated

January 6, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations