DepressionPhase 3NCT03586921
Primary Care Group Therapy for Depression/Anxiety for Women in Petropolis
A Phase 3 study testing Psychosocial Group Intervention in people with Depression and Anxiety Disorders, run by Rio de Janeiro State University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- Psychosocial Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2006to 15 Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- diagnosis of bipolar disorder, mania, severe suicidal ideation
- cognitive impairment that would limit their ability to consent or take part in the study. -pregnant.
About this study
Official title: Group Therapy in Primary Care for Women With Depression or Anxiety 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.
Read the 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.
- Conditions
- Depression, Anxiety Disorders
- Being tested
- Psychosocial Group Intervention, Enhanced Usual Care
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Group InterventionBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression (Beck Depression Inventory)
Depression measured by the Beck Depression Inventory
Measured: Change in depression 4 months post intervention
Depression (Beck Depression Inventory)
Depression measured by the Beck Depression Inventory
Measured: Change in depression 8 months post intervention
Secondary outcomes (5)
Anxiety (Beck Anxiety Inventory)
Anxiety as measured by the Beck Anxiety Inventory
Measured: 4 months post intervention
Anxiety (Beck Anxiety Inventory)
Anxiety as measured by the Beck Anxiety Inventory
Measured: 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
Measured: 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
Measured: 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
Measured: 8 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start19 May 2006
- Primary completion25 Sep 2007
- Study completion15 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosely Sichieri, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586921
- Sponsor's protocol ID
- DEP-ANX_PETROPOLIS
- Status last verified
- Jul 2018
- First submitted
- 21 Mar 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Therapy in Primary Care for Women With Depression or Anxiety in Petropolis
- ClinicalTrials.gov ID
- NCT03586921
- Acronym / sponsor ID
- DEP-ANX_PETROPOLIS
- Conditions
- Depression, Anxiety Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 19 May 2006 (actual)
- Primary completion
- 25 Sep 2007 (actual)
- Study completion
- 15 Jan 2008 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care + group intervention | Experimental | Behavioral: Psychosocial Group InterventionIntervention 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. |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- diagnosis of bipolar disorder, mania, severe suicidal ideation
- cognitive impairment that would limit their ability to consent or take part in the study. -pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial Group InterventionThe 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. | Behavioural | Enhanced usual care + group intervention |
| Enhanced Usual CareAll 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 |
Primary outcome
Depression (Beck Depression Inventory)
Time frame: Change in depression 4 months post intervention
Depression measured by the Beck Depression Inventory
Depression (Beck Depression Inventory)
Time frame: Change in depression 8 months post intervention
Depression measured by the Beck Depression Inventory
5 secondary outcomes
Anxiety (Beck Anxiety Inventory)
Time frame: 4 months post intervention
Anxiety (Beck Anxiety Inventory)
Time frame: 8 months post intervention
Quality of Life (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)
Time frame: 4 months post intervention
Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)
Time frame: 8 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Psychosocial Group Intervention in people with Depression and Anxiety Disorders, run by Rio de Janeiro State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (Beck Depression Inventory) (time frame: Change in depression 4 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.