Group Therapy in Primary Care for Women With Depression or Anxiety in Petropolis
Phase: PHASE3
Conditions: Depression, Anxiety Disorders
Sponsor: Rio de Janeiro State University

 
C O V E R   P A G E 
 
 
 
 
Official Title: Group Therapy in Primary Care for Women with Depression or 
Anxiety in Petropolis 
 
NCT number: Not yet assigned 
 
Date: July 12, 2018 
 
 

 
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 Setting 
The study was  conducted in 10 of 34 Family Health Units in deprived areas of 
Petrópolis, Rio de Janeiro, Brazil. Patients in the clinics typically shared low 
socioeconomic status, low levels of educational attainment, and high rates of 
unemployment and under-employment. The study was conducted between 2006 and 
2010.   
 
Interventions 
Given the high levels of anxiety and depression and the enormous unmet need for 
mental health services in Petrópolis, we decided to have two active arms of the study 
and to not exclude any patients identified with mental health problems from treatment. 
Patients positive for common mental disorders (anxiety and depression) were 
randomized to enhanced primary care vs. enhanced primary care plus group 
psychological intervention. 
 
Mental health care was delivered in the in the primary care clinic by the patients’ 
Family Health Team (doctor and nurse); a psychiatrist from the matrix team (Author 
SF) provided supervision for all services.     
 
All patients received enhanced primary care, which included: (1) The nurses and 
doctors from the Family Health Teams were trained by 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 adapted form the 

Chilean model to include anxiety as one of its targets (3) All providers received weekly  
group or individual consultation with a matrix support mental health professional, either 
psychiatrist or psychologist 
 
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.  
 
Procedures 
 
Recruitment was restricted to women for two reasons: they are the most frequent 
attenders of primary care units and the group of higher risk for anxiety and depressive 
disorders.(X) A two-stage screening process was used to identify female patients with 
current depressive and/or anxious disorders. All women age 18-65 attending the units 
for any reason were initially eligible for screening. Exclusion criteria assessed prior to 
screening were: cognitive impairment sufficient to preclude informed consent, 
pregnancy, treatment with antidepressants and neuroleptics for two months before the 
screening, psychoses, alcohol or drug dependence, bipolar disorder, or severe suicidal 
risk.    
 
Patients were screened with the General Health Questionnaire-12, with a cutoff point of 
4/5 indicating a positive finding. To confirm, a second administration of the GHQ-12 
was conducted fifteen days later for those who scored positive in the first screening. All 
women who were positive at both screenings were evaluated by psychiatry interns with 
the Mini (. Patients were invited to take part in the study if they presented a positive 

diagnosis for anxiety, depression, or both disorders according to the MINI and did not 
fulfill exclusion criteria.  
Randomization and follow up 
 
Patients who provided informed consent were randomized either to enhanced primary 
care or to enhanced primary care  + comprehensive stepped-care group treatment 
program. The same doctors and nurses, trained on treating anxiety and depression, led 
both arms of the study. Patients from control group were informed that they had 
depression or anxiety disorders and that they should come to the unit for consultation 
with their doctors and nurses on a treatment as usual basis, including prescription of 
psychotropic medication, Community health workers did not follow up on patients in 
the enhanced primary care arm if they did not show up for appointments.  
Follow up assessments were held at 4 (F1) and 8 (F2) months after the beginning 
of the intervention. Dropout rates from enrollment to the first follow-up were 5% and to 
the second-follow up were 13%. 
 
Measurement 
 
The following measures were administered in Portuguese: Beck Depression Inventory, 
Beck Anxiety Inventory and the World Health Organization Quality of Life 
Assessment-Brief Version. A general questionnaire to collect socio demographic and 
personal information was also administered.  
 
Analysis 
 
Using data from the Beck Depression and Anxiety Inventories, we analyzed three ways 
in which intervention and control group patients could demonstrate differences in 
anxiety and depression symptoms: (1) remission, as the percentage of patients who were 
negative for depression and anxiety before and after treatment, (2) reduction in severity 
level, the percentage of patients that had a reduction in the level of severity of the 
disorder they presented, and (3) secondary outcome of improvement in quality of life 
(World Health Organization Quality of Life Assessment-Brief Version). Analysis of 
repeated measures (baseline and two follow-ups) for each one of the outcomes were 
conducted using SPSS software. 

 
 
 
 
 
Recruitment 
 
 
 
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    women positive to GHQ>=5 
      Reavaluated – GHQ – 15 days later 
Women positive for GHQ>=5   MINI interview  
Baseline: 
women randomized evaluated by Beck  Anxiety/Depression; WHOQOL 
Control : Enhanced 
Individual Usual Care 
Intervention Enhanced 
usual care + groups+ 
active Search 
                              Follow up1: 4 months  
       Follow up 2: 8 months  
 All women18-68 recruited from waiting room for screened with