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NCT01441258 · ClinicalTrials.gov registry record · NA

Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression

A NA study, sponsored by Maurizio Fava, MD.

Completed
Registry status
NA
Development phase
26
Enrollment target

NCT01441258: Completed NA study, sponsored by Maurizio Fava, MD.

NCT01441258 is a NA study that has completed, run by Maurizio Fava, MD. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01441258, a NA study, has completed, sponsored by Maurizio Fava, MD.

COMPLETED
Registry status
NA
Development phase
26 participants
Enrollment target

Study Summary

Harley and colleagues demonstrated that adding Dialectical Behavior Therapy (DBT) skills-groups and therapist consultation to treatment as usual successfully reduced symptoms of depression. The present study will expand upon these findings. Second, DBT is not known for reducing suicidal ideation (SI), a major risk factor for suicide . The present study will tailor the aforementioned skills-groups to specifically target suicidal thoughts and behaviors through Cognitive Behavior Therapy (CBT) strategies aimed at increasing problem-solving deficits, hopelessness, and negativistic thinking. Third, the present study will extend this DBT-based approach to a novel population. Fourth, the present study is the first DBT intervention to employ state-of-the-art multi-method measurement (including objective assessment) of suicidal thoughts and behaviors. The investigators hypothesize that participants in the DBT skills (DBT-S) group will show improvements in level of suicidality as measured by decreased scores on the Beck Scale for Suicide Ideation as compared with participants in the Wait List-Treatment as Usual (WL-TAU) group.

Primary Outcome

If randomized to the intervention, they will be assessed monthly for 18 weeks, then at 3 and 6-month follow-up visits. If they are randomized to the Wait list-Treatment as Usual (WL-TAU) group and then cross over into the intervention group, they will be assessed for a total of 36 weeks, not including the 3 and 6-month follow-up assessments.

Interventions

  • BEHAVIORAL Dialectical Behavior Therapy Skills (DBT-S) Groups
  • BEHAVIORAL Wait List-Treatment as Usual
  • BEHAVIORAL No intervention-treatment as usual

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2011-10
Est. Completion 2015-02
Phase NA
Maurizio Fava, MD

4 total trials

What the finished NCT01441258 record still lists

NCT01441258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 3 interventions - of which Dialectical Behavior Therapy Skills (DBT-S) Groups is the first listed.

NCT01441258 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01441258 about?

NCT01441258 is a clinical study titled "Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression". Harley and colleagues demonstrated that adding Dialectical Behavior Therapy (DBT) skills-groups and therapist consultation to treatment as usual successfully reduced symptoms of depression. The present study will expand upon these findings. Second, DBT is not known for reducing suicidal ideation (SI...

What is the current status of trial NCT01441258?

This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2011-10. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01441258?

The interventions under investigation include: Dialectical Behavior Therapy Skills (DBT-S) Groups (BEHAVIORAL), Wait List-Treatment as Usual (BEHAVIORAL), No intervention-treatment as usual (BEHAVIORAL).

Who is sponsoring clinical trial NCT01441258?

This trial is sponsored by Maurizio Fava, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01441258's enrollment target sits among peer trials

26 1710th of 2000 higher than 289 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01441258, the US trial registry maintained by the National Library of Medicine. NCT01441258 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.