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Completed

NCT Number: NCT03586921

Primary Care Group Therapy for Depression/Anxiety for Women 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Depression (Beck Depression Inventory)

    Time frame: Change in depression 4 months post intervention

    Depression measured by the Beck Depression Inventory

  2. Depression (Beck Depression Inventory)

    Time frame: Change in depression 8 months post intervention

    Depression measured by the Beck Depression Inventory

Secondary outcomes

  1. Anxiety (Beck Anxiety Inventory)

    Time frame: 4 months post intervention

    Anxiety as measured by the Beck Anxiety Inventory

  2. Anxiety (Beck Anxiety Inventory)

    Time frame: 8 months post intervention

    Anxiety as measured by the Beck Anxiety Inventory

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

    Time frame: 4 months and 8 months post intervention

    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version

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

    Time frame: 4 months post intervention

    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version

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

    Time frame: 8 months post intervention

    QoL as measured by the World Health Organization Quality of Life Assessment, Brief Version

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jul 16, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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