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Clinical Trials/NCT03586921
NCT03586921CompletedPhase 3

Group Therapy in Primary Care for Women With Depression or Anxiety in Petropolis

Rio de Janeiro State University0 sites340 target enrollmentStarted: May 19, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
340
Primary Endpoint
Depression (Beck Depression Inventory)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Enhanced usual care + group intervention

Experimental

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.

Intervention: Psychosocial Group Intervention (Behavioral)

Enhanced Usual Care

Active Comparator

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: Enhanced Usual Care (Other)

Outcomes

Primary Outcomes

Depression (Beck Depression Inventory)

Time Frame: Change in depression 8 months post intervention

Depression measured by the Beck Depression Inventory

Depression (Beck Depression Inventory)

Time Frame: Change in depression 4 months post intervention

Depression measured by the Beck Depression Inventory

Secondary Outcomes

  • Anxiety (Beck Anxiety Inventory)(8 months post intervention)
  • Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)(8 months post intervention)
  • Anxiety (Beck Anxiety Inventory)(4 months post intervention)
  • Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)(4 months and 8 months post intervention)
  • Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)(4 months post intervention)

Investigators

Sponsor
Rio de Janeiro State University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rosely Sichieri

Associate Professor

Rio de Janeiro State University

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