NCT02449499

Brief Summary

Depression and anxiety disorders, even when treated according to standard of care consisting of individual treatment with medication and/or therapy, can be associated with significant residual impact on quality of life. The purpose of this research is carry out an observational study of an existing clinical treatment, adjunctive interpersonally focused psychodynamic group therapy, to determine if this can improve quality of life for patients who have residual symptoms of chronic depression and anxiety.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

April 7, 2015

Last Update Submit

October 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • psychological and general well-being index

    6 months

Secondary Outcomes (2)

  • ASQ (adult attachment style questionnaire)

    6 months

  • ICI (interpersonal communication inventory)

    6 months

Study Arms (2)

therapy

patients who meet inclusion criteria, continue to work with individual therapist, and participate in adjunct weekly group therapy

control

patients who meet inclusion criteria, continue to work with individual therapist, and are eligible for group therapy participation but cannot participate in group due to schedule constraints

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with major depression, adjustment disorder, generalized anxiety disorder, panic disorder, social phobia, or other depression NOS diagnosis currently in treatment with individual psychotherapist, continuing to experience symptoms even after at least six months in standard individual treatment with a psychiatrist or psychologist.

You may qualify if:

  • MINI diagnosis of major depression, adjustment disorder, generalized anxiety disorder, panic disorder, social phobia, or depression not otherwise specified (NOS)
  • PHQ9 \<20 and/or GAD7\>5 despite minimum of 6 months of prior psychiatric treatment
  • Poor interpersonal, social, academic, work or home function based on clinical assessment and subjective self-report
  • Effective engagement with group therapy task as assessed during standardized initial screening which is to demonstrate a willingness and ability to engage in an effective therapeutic manner with others in the group
  • Ongoing treatment by primary individual psychotherapist
  • Insurance with behavioral health coverage accepted at Stanford clinics

You may not qualify if:

  • Active serious medical conditions
  • Traumatic Brain Injury (TBI), dementia, developmental delay or severe cognitive impairment
  • Psychotic or substance abuse issues
  • On newly prescribed psychiatric medication \<30 days on stable target dose
  • Currently in acute depressive episode
  • Personality disorder
  • Suicidality
  • Inability to speak/understand English fluently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Psychiatry and Behavioral Science

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Carrie Holmberg, MD, PhD

    Stanford Psychiatry and Behavioral Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
protocol director

Study Record Dates

First Submitted

April 7, 2015

First Posted

May 20, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2016

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations