Depressive Disorder, MajorIPT-GinMDNCT04015206
Effectiveness of IPT-G in Major Depression
A study testing Group Interpersonal Psychotherapy in people with Depressive Disorder, Major, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Although antidepressants are the primary treatment for major depression, response and remission rates are unsatisfactory. The primary objective of this study is to identify if adding interpersonal group therapy (IPT-G) to the usual psychopharmacological and clinical management treatment will improve depressive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Group Interpersonal Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Aug 2019to 20 Mar 2021
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depressive Episode evaluated by the MINI-plus instrument.
- Patients attending the depression outpatient clinic (HCPorto Alegre) for 6 months or more
- History of two previous appropriate antidepressant treatments (dose: equivalent of 75 mg / day of amitriptyline and time: the minimum of four weeks)
- Beck Depression Inventory scores above 18.
Who cannot join
- Patients with bipolar disorder
- Patients with substance abuse disorder,
- Patients with risk of suicide
- Patients with antisocial personality disorder
- Patients with psychotic syndrome,
- Patients with intellectual disability
Show all 9Show fewer
- Patients receiving some kind of psychotherapy at the present time and in the last four weeks.
- Patients who are unable to communicate.
- Patients with Dismissive Attachment Style
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Effectiveness of Interpersonal Psychotherapy Group (IPT-G) as an add-on Strategy in the Treatment of Major Depression
Although antidepressants are the primary treatment for major depression, response and remission rates are unsatisfactory. The primary objective of this study is to identify if adding interpersonal group therapy (IPT-G) to the usual psychopharmacological and clinical management treatment will improve depressive symptoms in major depression outpatients.
Read the detailed description
Patients presenting a current unipolar depression episode (BDI-II > 18) without response to 2 adequate antidepressants trials (optimized by dose and time) will be randomly allocated to two arms: a) Treatment-as-usual (TAU) arm: antidepressant + Clinical management; b) Add-on strategy arm: 14 sessions of IPT-Group added to TAU.
IPT-Group will be delivered following manualized guidelines (WHO, 2016 and Stuart et al. 2012). The choice of antidepressants for TAU will be based on the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommendations. Clinical management will follow the National Institute for Mental Health (NIMH) recommendations for clinical management.
Depression episode will be diagnosed using the Mini International Neuropsychiatric Interview (MINI-PLUS).
The following variables will be evaluated at baseline and the end of the add-on intervention in both arms of the study:
- depression symptoms- Beck Depression Inventory (BDI-II; b) anxiety symptoms - Beck Anxiety Inventory (BAI); c) quality of life- World Health Organization Quality of life Instrument short version (WHOQOL-bref); d) social support- Medical Outcomes Study Social. Support Survey (MOS-SSS); e) resilience- The Brief Resilience Scale (BRS); f) attachment- The Adult Attachment Scale (AAS-R) Depression symptoms are the primary outcome. Anxiety symptoms and quality of life the secondary outcomes. Social support, resilience, and attachment will be considered as both secondary outcome and mediator or moderators in a multivariate model.
The database will be built using REDCap (Research Electronic Data Capture). Sample size estimation to detect a 5-point difference between the groups with a standard deviation of 6, considering α = 0,05 and power of 90%, suggests a 64 subjects sample. With the estimation of a loss of 25% of the sample during the study, 80 patients will be included (40 in each arm). A trained psychotherapist will conduct five IPT-G groups with eight patients in each group.
Study design and analysis will use Intention-to-treat analysis. For quantitative variables testing, student-T test t (normal distribution) or Mann Whitney (absence of normal distribution) will be used with a 5% level of significance. Categorical variables will be tested using the Chi-square with exact Fischer test with a 5% level of significance. Hierarchical linear regression will be used to determine the variables that could predict a reduction in the depression scores of the BDI-II. All analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 20.0.
- Conditions
- Depressive Disorder, Major
- Being tested
- Group Interpersonal Psychotherapy
- Keywords
- Major Depressive Disorder, Group Interpersonal Psychotherapy (IPT-G)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Interpersonal PsychotherapyOther
Also called IPT-G
Group Interpersonal Psychotherapy added to usual treatment (Pharmacotherapy + clinical management)
| Study group | Role | What they receive |
|---|---|---|
| IPT-G+UCT | Experimental | 10 sessions of Group Interpersonal therapy added to pharmacotherapy + clinical management plus one individual session pre-group and one session pos-group Receives: Other: Group Interpersonal Psychotherapy |
| Usual treatment (UCT) | Active comparator | Pharmacotherapy + Clinical management once a month Receives: Other: Group Interpersonal Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Depression symptoms
The Beck Depression Inventory (BDI- II) brazilian version is an self-evaluation instrument, that the scale total scores aims to identify and quantify mild, moderate and severe depression. The patient is invited to answer how he has felt in the last week.
The scale consists in 21 items including symptoms and attitudes, whose intensity varies from 0 to 3. The items refer to sadness, pessimism, past failure, lack of satisfaction, loss of pleasure, feelings of guilt, sense of punishment, self-steam, self-criticism, thoughts or desires of suicide, crying, agitation, loss of interest, indecision, devaluation, lack of energy, change in sleep patterns, irritability, changes in appetite, concentration difficulty, fatigue, loss of interest in sex.
For patients diagnosed with Major Depression, the cut points are: 0-13 minimum, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.
Measured: 14 weeks
Secondary outcomes (5)
Rate of Anxiety symptoms
The Beck Anxiety Inventory (BAI) brazilian version is a self-evaluation scale, total scores consists in 21 questions about how the individual has felt in the last week, expressed in common anxiety symptoms, such as sweating and feelings of anguish. The possible answers are: no, slightly, moderately and severely. The scores are: 0-10 minimum degree of anxiety, 11-19 mild anxiety, 20-30 moderate anxiety, 31-63 severe anxiety.
Measured: 14 weeks
Rate of Quality of life domains
Differences in the World Health Organization Quality of life abbreviated questionaire instrument (WHOQOL-Bref) brazilian version scale scores in four domains (Physical, Psychological, Social Relationships and Environmental).
Consists in 26 questions (each with a scale of Likert type composed of five degrees of intensity), two of them related to overall quality of life and health status and 24 facets of quality of life in general. The results can be: needs to improve (1 to 2,9), regular (3 to 3,9), good (4 to 4,9) and very good (5).
Measured: 14 weeks
Rate of Social support
Difference in the Social Support Scale (MOS) validated for Brazil scores. Composed of self-applied items, multiple choice with a score of 1 to 5 (Likert scale) evaluates the perception of individuals on social support in health contexts. It consists in 19 items distributed in 4 dimensions: positive social interaction, possible social support, affective social support, emotional social support and informational social support. The patient should answer to each option: never, rarely, sometimes, often or always. In the end, the results are transformed in a punctuation of 0 to 100.
Measured: 14 weeks
Rate of Resilience
Difference in the Brief Resilience Scale (BRS) total scores. The self-evaluation scale is a short version validated for Portuguese in Brazil and it is composed of 14 items, in the Likert format, with the score 1 to 7 for each question. It evaluates the perception of individuals about psychological characteristics linked to resilience. Higher overall scores indicate greater resilience. It is organized in 6 factors: self perception, future planning, social competences, family cohesion, social resources and structured style.
Measured: 14 weeks
Style of Attachment
Difference in the Adult Attachment Scale (AAS-R) scores. The Portuguese version will be used, which has previously been used in the Brazilian population. It is a self-evaluation scale that consists in 18 items, marked on a Likert scale of 5 points. It measures the attachment style of the adults defined according to 3 dimensions: anxiety, comfort with proximity and confidence in others.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start25 Aug 2019
- Primary completion20 Apr 2020
- Study completion20 Mar 2021
Why it stopped: We completed One group intervention but the COVID Pandemic forced us to pause the research. We have preliminary data from 18 participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Type: Interventional Enrollment: 104 participants Allocation: Randomized Intervention Model: Parallel
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo Fleck, PhD, Md., Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015206
- Sponsor's protocol ID
- 2018-0547
- Acronym
- IPT-GinMD
- Status last verified
- Mar 2021
- First submitted
- 13 Apr 2019
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interpersonal Psychotherapy Group (IPT-G) as an add-on Strategy in the Treatment of Major Depression
- ClinicalTrials.gov ID
- NCT04015206
- Acronym / sponsor ID
- IPT-GinMD / 2018-0547
- Conditions
- Depressive Disorder, Major
- Keywords
- Major Depressive Disorder, Group Interpersonal Psychotherapy (IPT-G)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We completed One group intervention but the COVID Pandemic forced us to pause the research. We have preliminary data from 18 participants.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 10 Jul 2019 (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.
Although antidepressants are the primary treatment for major depression, response and remission rates are unsatisfactory. The primary objective of this study is to identify if adding interpersonal group therapy (IPT-G) to the usual psychopharmacological and clinical management treatment will improve depressive symptoms in major depression outpatients.
Detailed description
Patients presenting a current unipolar depression episode (BDI-II > 18) without response to 2 adequate antidepressants trials (optimized by dose and time) will be randomly allocated to two arms: a) Treatment-as-usual (TAU) arm: antidepressant + Clinical management; b) Add-on strategy arm: 14 sessions of IPT-Group added to TAU.
IPT-Group will be delivered following manualized guidelines (WHO, 2016 and Stuart et al. 2012). The choice of antidepressants for TAU will be based on the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommendations. Clinical management will follow the National Institute for Mental Health (NIMH) recommendations for clinical management.
Depression episode will be diagnosed using the Mini International Neuropsychiatric Interview (MINI-PLUS).
The following variables will be evaluated at baseline and the end of the add-on intervention in both arms of the study:
- depression symptoms- Beck Depression Inventory (BDI-II; b) anxiety symptoms - Beck Anxiety Inventory (BAI); c) quality of life- World Health Organization Quality of life Instrument short version (WHOQOL-bref); d) social support- Medical Outcomes Study Social. Support Survey (MOS-SSS); e) resilience- The Brief Resilience Scale (BRS); f) attachment- The Adult Attachment Scale (AAS-R) Depression symptoms are the primary outcome. Anxiety symptoms and quality of life the secondary outcomes. Social support, resilience, and attachment will be considered as both secondary outcome and mediator or moderators in a multivariate model.
The database will be built using REDCap (Research Electronic Data Capture). Sample size estimation to detect a 5-point difference between the groups with a standard deviation of 6, considering α = 0,05 and power of 90%, suggests a 64 subjects sample. With the estimation of a loss of 25% of the sample during the study, 80 patients will be included (40 in each arm). A trained psychotherapist will conduct five IPT-G groups with eight patients in each group.
Study design and analysis will use Intention-to-treat analysis. For quantitative variables testing, student-T test t (normal distribution) or Mann Whitney (absence of normal distribution) will be used with a 5% level of significance. Categorical variables will be tested using the Chi-square with exact Fischer test with a 5% level of significance. Hierarchical linear regression will be used to determine the variables that could predict a reduction in the depression scores of the BDI-II. All analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 20.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study Type: Interventional Enrollment: 104 participants Allocation: Randomized Intervention Model: Parallel
| Arm | Type | Receives |
|---|---|---|
| IPT-G+UCT | Experimental | Other: Group Interpersonal Psychotherapy10 sessions of Group Interpersonal therapy added to pharmacotherapy + clinical management plus one individual session pre-group and one session pos-group |
| Usual treatment (UCT) | Active comparator | Other: Group Interpersonal PsychotherapyPharmacotherapy + Clinical management once a month |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Major Depressive Episode evaluated by the MINI-plus instrument.
- Patients attending the depression outpatient clinic (HCPorto Alegre) for 6 months or more
- History of two previous appropriate antidepressant treatments (dose: equivalent of 75 mg / day of amitriptyline and time: the minimum of four weeks)
- Beck Depression Inventory scores above 18.
Key exclusion criteria (9 listed)
- Patients with bipolar disorder
- Patients with substance abuse disorder,
- Patients with risk of suicide
- Patients with antisocial personality disorder
- Patients with psychotic syndrome,
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 |
|---|---|---|
| Group Interpersonal PsychotherapyAlso: IPT-GGroup Interpersonal Psychotherapy added to usual treatment (Pharmacotherapy + clinical management) | Other | IPT-G+UCT, Usual treatment (UCT) |
Primary outcome
Rate of Depression symptoms
Time frame: 14 weeks
The Beck Depression Inventory (BDI- II) brazilian version is an self-evaluation instrument, that the scale total scores aims to identify and quantify mild, moderate and severe depression. The patient is invited to answer how he has felt in the last week. The scale consists in 21 items including symptoms and attitudes, whose intensity varies from 0 to 3. The items refer to sadness, pessimism, past failure, lack of satisfaction, loss of pleasure, feelings of guilt, sense of punishment, self-steam, self-criticism, thoughts or desires of suicide, crying, agitation, loss of interest, indecision, devaluation, lack of energy, change in sleep patterns, irritability, changes in appetite, concentration difficulty, fatigue, loss of interest in sex. For patients diagnosed with Major Depression, the cut points are: 0-13 minimum, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.
5 secondary outcomes
Rate of Anxiety symptoms
Time frame: 14 weeks
Rate of Quality of life domains
Time frame: 14 weeks
Rate of Social support
Time frame: 14 weeks
Rate of Resilience
Time frame: 14 weeks
Style of Attachment
Time frame: 14 weeks
Results and safety
The study was stopped early (reason given: We completed One group intervention but the COVID Pandemic forced us to pause the research. We have preliminary data from 18 participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Depressive Disorder, Major
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
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.
Marcelo Fleck, PhD, Md. study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Interpersonal Psychotherapy in people with Depressive Disorder, Major, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: We completed One group intervention but the COVID Pandemic forced us to pause the research. We have preliminary data from 18 participants.). Results are not available in the source record.
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?
Rate of Depression symptoms (time frame: 14 weeks). 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 25 Mar 2021.