NCT05988489

Brief Summary

The purpose of this clinical trial is to assess whether 6 months of treatment with Dynamic Deconstructive Psychotherapy (DDP) is more effective for reducing thoughts of suicide in suicidal adolescents and young adults than usual care in the community supplemented with Brief Intervention and Contact (BIC). DDP and BIC are two evidence-based practices shown to be more effective than usual care at reducing suicidality. Participants will be randomly assigned to receive DDP treatment with safety planning and optional medication management or BIC treatment with safety planning and optional medication management. Participants in both groups will receive the assigned treatment at SUNY Upstate Medical University's Psychiatry High Risk Program (PHRP). Each participant is anticipated to take part in this trial for up to one year.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Oct 2023Sep 2027

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

August 4, 2023

Last Update Submit

April 21, 2026

Conditions

Keywords

SuicidePsychotherapyAdolescentOutpatients

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Suicide Ideation on the Combined Suicide Ideation (CSI) Score at 6 Months of Treatment

    The CSI score assesses the frequency and severity of suicide ideation. This score is calculated by adding the scores of two established measures, item 9 of the PHQ-9 (assessing frequency of suicide ideation) and the 5-item C-SSRS suicide ideation measure (assessing severity of suicide ideation). Possible scores range from 0-8, with higher scores indicating higher frequency and severity of suicide ideation.

    Baseline and 6 Months

Secondary Outcomes (8)

  • Change from Baseline in Depression on the Patient Health Questionnaire-9 (PHQ-9) Scale at 6 Months of Treatment

    Baseline and 6 Months

  • Change from Baseline in Anxiety on the Generalized Anxiety Disorder 7-Item Scale (GAD-7) at 6 Months of Treatment

    Baseline and 6 Months

  • Change from Baseline in Identifying Emotions on the Toronto Alexithymia Scale (TAS20) at 6 Months of Treatment

    Baseline and 6 Months

  • Change from Baseline in Self-Compassion on the Self-Compassion Scale at 6 Months of Treatment

    Baseline and 6 Months

  • Change from Baseline in Social Functioning on the Interpersonal Needs Questionnaire (INQ) at 6 Months of Treatment

    Baseline and 6 Months

  • +3 more secondary outcomes

Study Arms (2)

Dynamic Deconstructive Psychotherapy (DDP)

EXPERIMENTAL

53 participants will meet with an assigned DDP therapist in-person or through televideo for 50 to 60 minutes on a weekly basis for 12 months. Participants will also meet with a psychiatric provider for a 60-minute psychiatric consultation with at least monthly 30-minute follow-up visits. In addition, participants in this arm will have the option of attending family and group therapy if interested and indicated. At baseline, 3, 6, 9, and 12 months, participants will meet with a research coordinator for 60-minute visits to complete outcome measures.

Behavioral: Dynamic Deconstructive Psychotherapy (DDP)

Brief Intervention and Contact (BIC)

ACTIVE COMPARATOR

53 participants will meet with an assigned BIC therapist in-person or through televideo for an initial 60-minute visit with eight 30-minute follow-up contacts at 1, 2, 4 weeks and 2, 3, 4, 6 and 12 months after study entry. Participants will also meet with a psychiatric provider for a 60-minute psychiatric consultation with at least monthly 30 minute follow-up visits. In addition, participants in this arm will be encouraged to receive services in the community, such as weekly individual psychotherapy, family and group therapy. At baseline, 3, 6, 9, and 12 months, participants will meet with a research coordinator for 60-minute visits to complete outcome measures.

Behavioral: Brief Intervention and Contact (BIC)

Interventions

DDP treatment with an assigned therapist for up to 12 months

Dynamic Deconstructive Psychotherapy (DDP)

BIC treatment with an assigned therapist for up to 12 months

Brief Intervention and Contact (BIC)

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • CSSRS suicide ideation of ≥ 2 and PHQ-9 item 9 of ≥ 1
  • Ages 14 through 40 years old of both genders
  • Fluency in English
  • Willingness to enter outpatient treatment as evidenced by psychiatric consultation at the PHRP and attending a first session with their intake therapist
  • Willingness to be video-recorded
  • Completion of baseline outcomes measures

You may not qualify if:

  • Previous or current clinical diagnosis of schizophrenia, schizoaffective disorder or autism spectrum disorder as ascertained by self-report on the PHRP intake packet, or on their electronic medical records, or by psychiatric evaluation at the PHRP
  • BMI \< 18 for adults ≥ 18 years old, and BMI \< 17 for adolescents
  • Concurrent use of weekly ECT, ketamine, or esketamine
  • IQ \< 80 on the Peabody Picture Vocabulary Test
  • Current or previous treatment with Dynamic Deconstructive Psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University, Psychiatry High Risk Program (PHRP)

Syracuse, New York, 13210, United States

RECRUITING

Related Publications (20)

  • Curtin SC, Garnett MF, Ahmad FB. Provisional numbers and rates of suicide by month and demographic characteristics: United States, 2021. NVSS-Vital Statistics-Rapid Release. Report No. 24, 2022.

    BACKGROUND
  • DeCou CR, Comtois KA, Landes SJ. Dialectical Behavior Therapy Is Effective for the Treatment of Suicidal Behavior: A Meta-Analysis. Behav Ther. 2019 Jan;50(1):60-72. doi: 10.1016/j.beth.2018.03.009. Epub 2018 Mar 22.

    PMID: 30661567BACKGROUND
  • Doupnik SK, Rudd B, Schmutte T, Worsley D, Bowden CF, McCarthy E, Eggan E, Bridge JA, Marcus SC. Association of Suicide Prevention Interventions With Subsequent Suicide Attempts, Linkage to Follow-up Care, and Depression Symptoms for Acute Care Settings: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2020 Oct 1;77(10):1021-1030. doi: 10.1001/jamapsychiatry.2020.1586.

    PMID: 32584936BACKGROUND
  • Durkheim, E. Suicide: A study in sociology. Routledge, 2005.

    BACKGROUND
  • Goldman GA, Gregory RJ. Preliminary relationships between adherence and outcome in dynamic deconstructive psychotherapy. Psychotherapy (Chic). 2009 Dec;46(4):480-485. doi: 10.1037/a0017947.

    PMID: 22121844BACKGROUND
  • Gregory RJ, Chlebowski S, Kang D, Remen AL, Soderberg MG, Stepkovitch J, Virk S. A controlled trial of psychodynamic psychotherapy for co-occurring borderline personality disorder and alcohol use disorder. Psychotherapy (Chic). 2008 Mar;45(1):28-41. doi: 10.1037/0033-3204.45.1.28.

    PMID: 22122363BACKGROUND
  • Gregory RJ, Sachdeva S. Naturalistic Outcomes of Evidence-Based Therapies for Borderline Personality Disorder at a Medical University Clinic. Am J Psychother. 2016;70(2):167-84. doi: 10.1176/appi.psychotherapy.2016.70.2.167.

    PMID: 27329405BACKGROUND
  • Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1.

    PMID: 29207961BACKGROUND
  • Kothgassner OD, Goreis A, Robinson K, Huscsava MM, Schmahl C, Plener PL. Efficacy of dialectical behavior therapy for adolescent self-harm and suicidal ideation: a systematic review and meta-analysis. Psychol Med. 2021 May;51(7):1057-1067. doi: 10.1017/S0033291721001355. Epub 2021 Apr 20.

    PMID: 33875025BACKGROUND
  • Layman DM, Kammer J, Leckman-Westin E, Hogan M, Goldstein Grumet J, Labouliere CD, Stanley B, Carruthers J, Finnerty M. The Relationship Between Suicidal Behaviors and Zero Suicide Organizational Best Practices in Outpatient Mental Health Clinics. Psychiatr Serv. 2021 Oct 1;72(10):1118-1125. doi: 10.1176/appi.ps.202000525. Epub 2021 Mar 18.

    PMID: 33730886BACKGROUND
  • Majdara E, Rahimmian I, Talepassand S, Gregory RJ. A Randomized Trial of Dynamic Deconstructive Psychotherapy in Iran for Borderline Personality Disorder. J Am Psychoanal Assoc. 2019 Oct;67(5):NP1-NP7. doi: 10.1177/0003065119891390. No abstract available.

    PMID: 31850790BACKGROUND
  • Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, O'Connor RC, Smit JH, Kerkhof A, Riper H. Safety planning-type interventions for suicide prevention: meta-analysis. Br J Psychiatry. 2021 Aug;219(2):419-426. doi: 10.1192/bjp.2021.50.

    PMID: 35048835BACKGROUND
  • Riblet NB, Stevens SP, Watts BV, Gui J, Forehand J, Cornelius S, Powell R, Lewicki K, Wasserman D, Shiner B. A Pilot Randomized Trial of a Brief Intervention to Prevent Suicide After Inpatient Psychiatric Discharge. Psychiatr Serv. 2021 Nov 1;72(11):1320-1323. doi: 10.1176/appi.ps.202000537. Epub 2021 May 12.

    PMID: 33979200BACKGROUND
  • Riblet NBV, Shiner B, Young-Xu Y, Watts BV. Strategies to prevent death by suicide: meta-analysis of randomised controlled trials. Br J Psychiatry. 2017 Jun;210(6):396-402. doi: 10.1192/bjp.bp.116.187799. Epub 2017 Apr 20.

    PMID: 28428338BACKGROUND
  • Sobanski T, Josfeld S, Peikert G, Wagner G. Psychotherapeutic interventions for the prevention of suicide re-attempts: a systematic review. Psychol Med. 2021 Nov;51(15):2525-2540. doi: 10.1017/S0033291721003081. Epub 2021 Oct 5.

    PMID: 34608856BACKGROUND
  • Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776.

    PMID: 29998307BACKGROUND
  • Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. doi: 10.1002/cpt1974155443. No abstract available.

    PMID: 4597226BACKGROUND
  • Tay JL, Li Z. Brief contact interventions to reduce suicide among discharged patients with mental health disorders-A meta-analysis of RCTs. Suicide Life Threat Behav. 2022 Dec;52(6):1074-1095. doi: 10.1111/sltb.12903. Epub 2022 Jul 28.

    PMID: 35899821BACKGROUND
  • Van Orden KA, Witte TK, Cukrowicz KC, Braithwaite SR, Selby EA, Joiner TE Jr. The interpersonal theory of suicide. Psychol Rev. 2010 Apr;117(2):575-600. doi: 10.1037/a0018697.

    PMID: 20438238BACKGROUND
  • World Health Organization. Multisite Intervention Study on Suicidal Behaviours - SUPRE-MISS: Protocol of SUPRE-MISS. WHO, Geneva, 2002.

    BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationSuicide

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robert J Gregory, MD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica P Helfrich, BA

CONTACT

Robert J Gregory, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

October 25, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Interested researchers from outside of SUNY Upstate Medical University will submit a written request to the Principal Investigator, Robert Gregory, MD, after creating a well-defined research proposal and attaining approval from their IRB. The Principal Investigator will decide whether to approve the request and subsequently email a de-identified dataset of the participant outcomes.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will become available to other researchers after publication of the main study results and will be available for 10 years after data collection of the primary outcome.
Access Criteria
The requesting researcher must be a faculty member from an academic institution and have an IRB-approved research protocol.

Locations