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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586921
• Other study ID #: DEP-ANX_PETROPOLIS
• Status: Completed
• Phase: Phase 3
• Start date: May 19, 2006
• Est. completion date: January 15, 2008

Study information

• Verified date: July 2018
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: January 15, 2008
• Est. primary completion date: September 25, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression (Beck Depression Inventory)	Depression measured by the Beck Depression Inventory	Change in depression 4 months post intervention
Primary	Depression (Beck Depression Inventory)	Depression measured by the Beck Depression Inventory	Change in depression 8 months post intervention
Secondary	Anxiety (Beck Anxiety Inventory)	Anxiety as measured by the Beck Anxiety Inventory	4 months post intervention
Secondary	Anxiety (Beck Anxiety Inventory)	Anxiety as measured by the Beck Anxiety Inventory	8 months post intervention
Secondary	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
Secondary	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
Secondary	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