A Phase 3 interventional study of Psychosocial Group Intervention and Enhanced Usual Care in Depression and Anxiety Disorders, sponsored by Rio de Janeiro State University. Completed. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by Rio de Janeiro State University · Phase 3, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 340 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Rio de Janeiro State University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
Depression (Beck Depression Inventory)
Depression measured by the Beck Depression Inventory
Time frame: Change in depression 4 months post intervention
Depression (Beck Depression Inventory)
Depression measured by the Beck Depression Inventory
Time frame: Change in depression 8 months post intervention
Anxiety (Beck Anxiety Inventory)
Anxiety as measured by the Beck Anxiety Inventory
Time frame: 4 months post intervention
Anxiety (Beck Anxiety Inventory)
Anxiety as measured by the Beck Anxiety Inventory
Time frame: 8 months post intervention
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
Time frame: 4 months and 8 months post intervention
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
Time frame: 4 months post intervention
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
Time frame: 8 months post intervention
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rio de Janeiro State University