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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety Disorders
• Intervention / Treatment: Behavioral: Psychosocial Group Intervention; Other: Enhanced Usual 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 Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression (Beck Depression Inventory)	Depression measured by the Beck Depression Inventory	Change in depression 4 months post intervention
Depression (Beck Depression Inventory)	Depression measured by the Beck Depression Inventory	Change in depression 8 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety (Beck Anxiety Inventory)	Anxiety as measured by the Beck Anxiety Inventory	4 months post intervention
Anxiety (Beck Anxiety Inventory)	Anxiety as measured by the Beck Anxiety Inventory	8 months post intervention
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	4 months and 8 months post intervention
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	4 months post intervention
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	8 months post intervention

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2006
• Primary Completion (Actual): September 25, 2007
• Study Completion (Actual): January 15, 2008

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: DEP-ANX_PETROPOLIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No