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

NCT03586921 | Completed Phase 3

• 1 other identifier: DEP-ANX_PETROPOLIS
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Anxiety (Beck Anxiety Inventory)

  4 months post intervention

• Anxiety (Beck Anxiety Inventory)

  8 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

• Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)

  8 months post intervention

Study Arms (2)

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.

Behavioral: Psychosocial Group Intervention

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.

Other: Enhanced Usual Care

Interventions

Psychosocial Group Intervention BEHAVIORAL

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.

Enhanced usual care + group intervention

Enhanced Usual Care OTHER

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Since this is a study of depression in women, we included only those who identify as women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• diagnosis of bipolar disorder, mania, severe suicidal ideation
• cognitive impairment that would limit their ability to consent or take part in the study. -pregnant.

Sponsors & Collaborators

• Rio de Janeiro State University: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: July 16, 2018
• Study Start: May 19, 2006
• Primary Completion: September 25, 2007
• Study Completion: January 15, 2008
• Last Updated: July 16, 2018

Record last verified: 2018-07