NCT01868711

Brief Summary

Psychological mindedness(PM) is a metacognitive process in which the person uses his cognitive and affective abilities to understand his thoughts, feelings, and his behaviors as they interact with his internal experiences and his external experiences in the world. It dynamically modifies his behavior to move towards self-actualization in a manner positive to himself and the world. We investigate whether the assessment of PM can distinguish depressed patients who benefit from CBT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable depression

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

First Submitted

Initial submission to the registry

May 20, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

9.9 years

First QC Date

May 20, 2013

Last Update Submit

May 16, 2024

Conditions

Keywords

Cognitive Behavior TherapySelf-awarnessSupportive TherapyVirtual psychotherapy

Outcome Measures

Primary Outcomes (1)

  • Level of depression as measured by the Hamilton Depression Rating Scale

    Outcome measure of depression will be assessed as the change in depression between baseline (pre-treatment) and post treatment (up to 12 weeks).

    Up to 12 weeks.

Study Arms (2)

*Cognitive behavior therapy

ACTIVE COMPARATOR

Depressed patients will receive 12 virtual sessions of cognitive behavior therapy (CBT) for depression. CBT Includes behavior activation, correcting distorted thoughts, and other tools to reduce symptoms.

Behavioral: Cognitive Behavior Therapy

Supportive psychotherapy

OTHER

Supportive psychotherapy aims to strengthen the patient's ability to cope effectively with various life stressors. Specifically, in our study, supportive psychotherapy will be geared towards reducing or alleviating symptoms of depression. The sessions will be administered virtually.

Behavioral: Cognitive Behavior Therapy

Interventions

Also known as: Supportive psychotherapy
*Cognitive behavior therapySupportive psychotherapy

Eligibility Criteria

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

You may qualify if:

  • Males or females between the ages of 18 and 65 (inclusive).
  • Primary DSM-IV-TR diagnosis of major depression
  • A negative urine toxicology, i.e., a urine specimen that does not test positive for the use of drugs of abuse or use of benzodiazepines.
  • Ability to give informed consent.
  • Fluent in English

You may not qualify if:

  • Patients who have a "lifetime" history of Schizophrenia or other current psychotic disorder, Major Depressive Disorder with Psychotic or Catatonic features, Bipolar I Affective Disorder, or Organic Mental Disease.
  • DSM-V substance abuse or dependence within the past 6 months (except nicotine or caffeine).
  • Active suicidal or homicidal ideation, or judged to be at serious suicide risk.
  • Any unstable medical or neurological condition.
  • Presently receiving psychotherapy or psychotropic medications.
  • Prior History of CBT for Depression treatment failure.
  • Left-handedness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ronit Kishon, Ph.D.

    New York State Psychiatric Institute, Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Depressed patients will be randomized between cognitive behavor therapy and supportive therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

May 20, 2013

First Posted

June 4, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2023

Study Completion

June 2, 2023

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations