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

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ClinicalTrials.gov Identifier: NCT03586921
Recruitment Status : Completed
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Rosely Sichieri, Rio de Janeiro State University

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Disorders Behavioral: Psychosocial Group Intervention Other: Enhanced Usual Care Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Group Therapy in Primary Care for Women With Depression or Anxiety in Petropolis
Actual Study Start Date : May 19, 2006
Actual Primary Completion Date : September 25, 2007
Actual Study Completion Date : January 15, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Enhanced usual care + group intervention
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.
Behavioral: Psychosocial 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.

Active Comparator: Enhanced Usual Care
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.
Other: Enhanced Usual Care
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 Measures :
  1. Depression (Beck Depression Inventory) [ Time Frame: Change in depression 4 months post intervention ]
    Depression measured by the Beck Depression Inventory

  2. Depression (Beck Depression Inventory) [ Time Frame: Change in depression 8 months post intervention ]
    Depression measured by the Beck Depression Inventory


Secondary Outcome Measures :
  1. Anxiety (Beck Anxiety Inventory) [ Time Frame: 4 months post intervention ]
    Anxiety as measured by the Beck Anxiety Inventory

  2. Anxiety (Beck Anxiety Inventory) [ Time Frame: 8 months post intervention ]
    Anxiety as measured by the Beck Anxiety Inventory

  3. Quality of Life (World Health Organization Quality of Life Assessment, Brief Version) [ Time Frame: 4 months and 8 months post intervention ]
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version

  4. Quality of Life (World Health Organization Quality of Life Assessment, Brief Version) [ Time Frame: 4 months post intervention ]
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version

  5. Quality of Life (World Health Organization Quality of Life Assessment, Brief Version) [ Time Frame: 8 months post intervention ]
    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Since this is a study of depression in women, we included only those who identify as women.
Accepts Healthy Volunteers:   No
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.
  Study Documents (Full-Text)

Documents provided by Rosely Sichieri, Rio de Janeiro State University:

Responsible Party: Rosely Sichieri, Associate Professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT03586921     History of Changes
Other Study ID Numbers: DEP-ANX_PETROPOLIS
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders