Clinical trial NCT03586921: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Anxiety Disorders
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Depression (Beck Depression Inventory)
timeFrame: Change in depression 4 months post intervention
measure: Depression (Beck Depression Inventory)
timeFrame: Change in depression 8 months post intervention
Secondary outcomes:
measure: Anxiety (Beck Anxiety Inventory)
timeFrame: 4 months post intervention
measure: Anxiety (Beck Anxiety Inventory)
timeFrame: 8 months post intervention
measure: Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
timeFrame: 4 months and 8 months post intervention
measure: Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
timeFrame: 4 months post intervention
measure: Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
timeFrame: 8 months post intervention
Other outcomes:
Locations:
Study officials:
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