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Primary Care Group Therapy for Depression/Anxiety for Women in Petropolis

Primary Purpose

Depression, Anxiety Disorders

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Psychosocial Group Intervention
Enhanced Usual Care
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female patients who came to the primary care unit for any type of consultation for themselves (e.g., not for a child).
  • General Health Questionnaire positive screen (>5 at two time points)
  • positive diagnosis of depression or anxiety per the Mini Mental State Examination.

Exclusion Criteria:

  • diagnosis of bipolar disorder, mania, severe suicidal ideation
  • cognitive impairment that would limit their ability to consent or take part in the study. -pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Enhanced usual care + group intervention

    Enhanced Usual Care

    Arm Description

    Intervention patients received enhanced primary care plus a 9-session group intervention. The intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party. The patients from the intervention arm also received additional outreach from the Family Health Teams, including home delivery of psychotropic medication when needed and active outreach and engagement by community workers if patients missed group sessions.

    All patients received enhanced primary care: (1) Nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) All providers received weekly group or individual consultation with a Matrix team mental health professional, either psychiatrist or psychologist. An qualitative study of participating Petrópolis Family Health Programme doctors and nurses demonstrated their satisfaction with the training.

    Outcomes

    Primary Outcome Measures

    Depression (Beck Depression Inventory)
    Depression measured by the Beck Depression Inventory
    Depression (Beck Depression Inventory)
    Depression measured by the Beck Depression Inventory

    Secondary Outcome Measures

    Anxiety (Beck Anxiety Inventory)
    Anxiety as measured by the Beck Anxiety Inventory
    Anxiety (Beck Anxiety Inventory)
    Anxiety as measured by the Beck Anxiety Inventory
    Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version
    Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version
    Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version

    Full Information

    First Posted
    March 21, 2018
    Last Updated
    July 13, 2018
    Sponsor
    Rio de Janeiro State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03586921
    Brief Title
    Primary Care Group Therapy for Depression/Anxiety for Women in Petropolis
    Official Title
    Group Therapy in Primary Care for Women With Depression or Anxiety in Petropolis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 19, 2006 (Actual)
    Primary Completion Date
    September 25, 2007 (Actual)
    Study Completion Date
    January 15, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rio de Janeiro State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized controlled trial comparing two groups: 1) Enhanced usual care and 2) Enhanced usual care plus group psychological intervention. In both groups a "stepped care" approach was used to the management of anxiety and depression among women seen in primary care.
    Detailed Description
    All patients received enhanced primary care, which included: (1) The nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety, including diagnosis, appropriate medication interventions, psycho-education, and cognitive and problem solving therapy. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) All providers received weekly group or individual consultation with a Matrix team mental health professional, either psychiatrist or psychologist. An qualitative study of participating Petrópolis Family Health Programme doctors and nurses demonstrated their satisfaction with the training. Patients in the intervention arm received enhanced primary care plus a 9-session group intervention (seven sessions weekly then two sessions every 15 days). The intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party. The patients from the intervention arm also received additional outreach from the Family Health Teams, including home delivery of psychotropic medication when needed and active outreach and engagement by community workers if patients missed group sessions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    All patients received enhanced primary care, which included: (1) The nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety, including diagnosis, appropriate medication interventions, psycho-education, and cognitive and problem solving therapy. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    340 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Enhanced usual care + group intervention
    Arm Type
    Experimental
    Arm Description
    Intervention patients received enhanced primary care plus a 9-session group intervention. The intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party. The patients from the intervention arm also received additional outreach from the Family Health Teams, including home delivery of psychotropic medication when needed and active outreach and engagement by community workers if patients missed group sessions.
    Arm Title
    Enhanced Usual Care
    Arm Type
    Active Comparator
    Arm Description
    All patients received enhanced primary care: (1) Nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) All providers received weekly group or individual consultation with a Matrix team mental health professional, either psychiatrist or psychologist. An qualitative study of participating Petrópolis Family Health Programme doctors and nurses demonstrated their satisfaction with the training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychosocial Group Intervention
    Intervention Description
    The intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party.
    Intervention Type
    Other
    Intervention Name(s)
    Enhanced Usual Care
    Intervention Description
    All patients received enhanced primary care: (1) Nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) All providers received weekly group or individual consultation with a Matrix team mental health professional, either psychiatrist or psychologist. An qualitative study of participating Petrópolis Family Health Programme doctors and nurses demonstrated their satisfaction with the training.
    Primary Outcome Measure Information:
    Title
    Depression (Beck Depression Inventory)
    Description
    Depression measured by the Beck Depression Inventory
    Time Frame
    Change in depression 4 months post intervention
    Title
    Depression (Beck Depression Inventory)
    Description
    Depression measured by the Beck Depression Inventory
    Time Frame
    Change in depression 8 months post intervention
    Secondary Outcome Measure Information:
    Title
    Anxiety (Beck Anxiety Inventory)
    Description
    Anxiety as measured by the Beck Anxiety Inventory
    Time Frame
    4 months post intervention
    Title
    Anxiety (Beck Anxiety Inventory)
    Description
    Anxiety as measured by the Beck Anxiety Inventory
    Time Frame
    8 months post intervention
    Title
    Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
    Description
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version
    Time Frame
    4 months and 8 months post intervention
    Title
    Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
    Description
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version
    Time Frame
    4 months post intervention
    Title
    Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
    Description
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version
    Time Frame
    8 months post intervention

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Since this is a study of depression in women, we included only those who identify as women.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: female patients who came to the primary care unit for any type of consultation for themselves (e.g., not for a child). General Health Questionnaire positive screen (>5 at two time points) positive diagnosis of depression or anxiety per the Mini Mental State Examination. Exclusion Criteria: diagnosis of bipolar disorder, mania, severe suicidal ideation cognitive impairment that would limit their ability to consent or take part in the study. -pregnant.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Primary Care Group Therapy for Depression/Anxiety for Women in Petropolis

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