Major Depressive DisorderNCT01867749
Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss
A study testing Group Interpersonal Psychotherapy (IPT-G) and Coping with Depression (CWD) in people with Major Depressive Disorder and Miscarriage, run by Brown University at 1 site in United States.
Trial summary
The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the feasibility of the proposed recruitment methods and research design, of the therapist training methods, and of delivering… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Major Depressive Disorder, Miscarriage, Stillbirth
- What is being tested?
- Group Interpersonal Psychotherapy (IPT-G) and Coping with Depression (CWD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2014
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Current Major Depressive episode.
- Experience perinatal loss 1-18 months prior to intake (including early and late fetal death and the death of a live born neonate within the first 28 days).
Who cannot join
- Untreated thyroid difficulties (TSH levels out of the normal range).
- Anemia (hemoglobin or hematocrit out of the normal range).
- Onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included).
- Current or past diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder.
- Primary diagnosis of substance dependence or eating disorder.
- Acute suicidal or homicidal risk.
- Non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 8 weeks).
- Any IPT or cognitive-behavioral treatment in the previous 8 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the feasibility of the proposed recruitment methods and research design, of the therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group treatment.
The investigators would like to examine preliminary evidence for the following hypotheses:
- Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD following perinatal loss than will Coping with Depression (CWD).
- Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and reduced depressive symptoms relative to CWD.
- Perinatal-loss specific IPT-G will result in increased social support and social functioning, reduced couple distress, and reduced grief relative to CWD.
- Conditions
- Major Depressive Disorder, Miscarriage, Stillbirth, Neonatal Death
- Being tested
- Group Interpersonal Psychotherapy (IPT-G), Coping with Depression (CWD)
- Keywords
- Major Depressive Disorder (MDD), Miscarriage, Stillbirth, Neonatal death, Interpersonal psychotherapy, Group Therapy, Coping with Depression (CWD)
- Medical subject headings
- Depressive Disorder, Major, Abortion, Spontaneous, Stillbirth, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Interpersonal Psychotherapy (IPT-G)Behavioural
Also called IPT-G
Coping with Depression (CWD)Behavioural
Also called CWD
| Study group | Role | What they receive |
|---|---|---|
| Group Interpersonal Psychotherapy (IPT-G) | Experimental | Participants in the IPT-G condition will receive 12 group therapy sessions over 2 weeks as well as 2 individual (pre-group and 1-month booster sessions). In addition, 3 of the 12 group sessions will invite women to include their partners or other support people to bolster the woman's social support system and to reduce conflicts over how to react to the loss. This study adapted IPT for treatment of depression after perinatal loss. Receives: Behavioral: Group Interpersonal Psychotherapy (IPT-G) |
| Coping with Depression (CWD) | Active comparator | The Coping with Depression (CWD) course is a highly structured, manualized psycho-educational group treatment for MDD. The course content is cognitive-behavioral in nature and is designed to train skills that can be used in the alleviation of depression. The skill modules focus on relaxation, cognitive skills, and behavioral activation. CWD will consist of an individual pre-group interview, 12 group therapy sessions over 12 weeks and a 1-month individual booster session to provide an identical treatment dose as the experimental condition. Receives: Behavioral: Coping with Depression (CWD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Acceptability
Treatment acceptability measured by the End of Treatment Questionnaire and the client satisfaction questionnaire.
Measured: Post Treatment (12 Weeks)
Reduced time to remission from major depressive disorder (exploratory in this underpowered feasibility/acceptability study)
We will calculate the effect size and confidence intervals for time to remission from depressive episode. Remission will be defined as number of weeks until Hamilton Rating Scale for Depression score of 7 or less. Recovery from major depression is an exploratory aim; it will be defined as 8+ consecutive weeks on the Longitudinal Interval Follow-up Evaluation PSR scores of 1 or 2. Exploratory tests for differences between conditions will use Cox regression, with initial HRSD scores as a covariate.
Measured: Survival analysis
Reduction in depressive symptoms (exploratory in this underpowered feasibility/acceptability study)
We will calculate the effect sizes and confidence intervals for reduction in depressive symptoms using HRSD and BDI-II scores. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.
Measured: Slopes over time
Secondary outcomes (3)
Perceived Social Support
We will calculate effect sizes and confidence intervals for improvement in social support and social functioning using the Multidimensional Scale of Perceived Social Support and the Social Adjustment Scale. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.
Measured: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
Couple Distress
Social adjustment as measured by the Dyadic Adjustment Scale (DAS). We will calculate effect sizes and confidence intervals for reduction in couple distress using the DAS. Exploratory tests for differences between conditions will use HLM with baseline DAS scores as a covariate.
Measured: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
Grief
Grief as measured by the Perinatal Bereavement Grief Scale and the Inventory of Complicated Grief. We will calculate effect sizes and confidence intervals for reduction in grief using the PBGS and ICG. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates. Although not the primary focus of this study, we will also calculate the NNT for prevention of complicated grief diagnosis.
Measured: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dr. Jennifer Johnson, Brown University
- Investigators
- Jennifer E. Johnson, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867749
- Sponsor's protocol ID
- 5R34MH086682-03
- Other IDs
- 5R34MH086682-03
- Status last verified
- Jan 2016
- First submitted
- 28 May 2013
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss
- ClinicalTrials.gov ID
- NCT01867749
- Acronym / sponsor ID
- 5R34MH086682-03
- Conditions
- Major Depressive Disorder, Miscarriage, Stillbirth, Neonatal Death
- Keywords
- Major Depressive Disorder (MDD), Miscarriage, Stillbirth, Neonatal death, Interpersonal psychotherapy, Group Therapy, Coping with Depression (CWD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- 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.
The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the feasibility of the proposed recruitment methods and research design, of the therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group treatment.
The investigators would like to examine preliminary evidence for the following hypotheses:
- Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD following perinatal loss than will Coping with Depression (CWD).
- Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and reduced depressive symptoms relative to CWD.
- Perinatal-loss specific IPT-G will result in increased social support and social functioning, reduced couple distress, and reduced grief relative to CWD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Interpersonal Psychotherapy (IPT-G) | Experimental | Behavioral: Group Interpersonal Psychotherapy (IPT-G)Participants in the IPT-G condition will receive 12 group therapy sessions over 2 weeks as well as 2 individual (pre-group and 1-month booster sessions). In addition, 3 of the 12 group sessions will invite women to include their partners or other support people to bolster the woman's social support system and to reduce conflicts over how to react to the loss. This study adapted IPT for treatment of depression after perinatal loss. |
| Coping with Depression (CWD) | Active comparator | Behavioral: Coping with Depression (CWD)The Coping with Depression (CWD) course is a highly structured, manualized psycho-educational group treatment for MDD. The course content is cognitive-behavioral in nature and is designed to train skills that can be used in the alleviation of depression. The skill modules focus on relaxation, cognitive skills, and behavioral activation. CWD will consist of an individual pre-group interview, 12 group therapy sessions over 12 weeks and a 1-month individual booster session to provide an identical treatment dose as the experimental condition. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Current Major Depressive episode.
- Experience perinatal loss 1-18 months prior to intake (including early and late fetal death and the death of a live born neonate within the first 28 days).
Key exclusion criteria (8 listed)
- Untreated thyroid difficulties (TSH levels out of the normal range).
- Anemia (hemoglobin or hematocrit out of the normal range).
- Onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included).
- Current or past diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder.
- Primary diagnosis of substance dependence or eating disorder.
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 Psychotherapy (IPT-G)Also: IPT-G | Behavioural | Group Interpersonal Psychotherapy (IPT-G) |
| Coping with Depression (CWD)Also: CWD | Behavioural | Coping with Depression (CWD) |
Primary outcome
Treatment Acceptability
Time frame: Post Treatment (12 Weeks)
Treatment acceptability measured by the End of Treatment Questionnaire and the client satisfaction questionnaire.
Reduced time to remission from major depressive disorder (exploratory in this underpowered feasibility/acceptability study)
Time frame: Survival analysis
We will calculate the effect size and confidence intervals for time to remission from depressive episode. Remission will be defined as number of weeks until Hamilton Rating Scale for Depression score of 7 or less. Recovery from major depression is an exploratory aim; it will be defined as 8+ consecutive weeks on the Longitudinal Interval Follow-up Evaluation PSR scores of 1 or 2. Exploratory tests for differences between conditions will use Cox regression, with initial HRSD scores as a covariate.
Reduction in depressive symptoms (exploratory in this underpowered feasibility/acceptability study)
Time frame: Slopes over time
We will calculate the effect sizes and confidence intervals for reduction in depressive symptoms using HRSD and BDI-II scores. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.
3 secondary outcomes
Perceived Social Support
Time frame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
Couple Distress
Time frame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
Grief
Time frame: Slope over time: Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 3 Months, 6 Months
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 13 Jan 2016.
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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.
Jennifer E. Johnson, Ph.D. principal investigator
Brown University
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 (IPT-G) and Coping with Depression (CWD) in people with Major Depressive Disorder and Miscarriage, run by Brown University at 1 site in United States.
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 2 inclusion and 8 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 13 Jan 2016. 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 United States. 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 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?
Treatment Acceptability (time frame: Post Treatment (12 Weeks)). The study lists 3 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 13 Jan 2016.