Major Depressive DisorderPhase 3NCT01685294
Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression
A Phase 3 study testing Group IPT for Depression + TAU in people with Major Depressive Disorder, run by Brown University at 5 sites in United States.
Trial summary
This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Group IPT for Depression + TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2011to Oct 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet all DSM-IV criteria for primary (non-substance induced) major depressive disorder
- Expectation of at least 6 months of incarceration at baseline interview
- Incarcerated for at least 4 weeks
Who cannot join
- Lifetime:
- Bipolar disorder
- Psychotic disorder
- Are imminently suicidal
- Cannot understand English well enough to understand the consent form or assessment instruments when read aloud
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts Correctional Institute - Old Colony Correctional Center
Bridgewater, Massachusetts, 02324
Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities
Cranston, Rhode Island, 02920
Massachusetts Correctional Institution - Framingham
Framingham, Massachusetts, 01702
South Middlesex Correctional Center
Framingham, Massachusetts, 01702
Massachusetts Correctional Institution - Norfolk
Norfolk, Massachusetts, 02056
About this study
This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.
Read the detailed description
The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment in criminal justice settings by conducting a fully-powered randomized effectiveness study that collects pilot implementation data, including cost-effectiveness data. Group IPT will be compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD from 4 institutions, allowing us to explore gender effects.
- Conditions
- Major Depressive Disorder
- Being tested
- Group IPT for Depression + TAU
- Keywords
- Major Depressive Disorder (MDD), Suicidality, Incarcerated Populations, Prisons, Interpersonal Psychotherapy (IPT)
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group IPT for Depression + TAUBehavioural
Interpersonal psychotherapy (IPT) will be administered in 20 group 90-minute sessions over 10 weeks and 4 individual sessions (before group starts, in the middle of the group, at the end of the group, and one month after the group ends). These sessions will focus on improving your relationships with others, building healthy relationships, setting goals, and increasing coping skills. Additionally, participants will receive standard prison mental health treatment, individual therapy, medication, etc.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc. |
| Group Interpersonal Psychotherapy (IPT) for Depression + TAU | Experimental | Participants will receive Group IPT for Depression + TAU. Receives: Behavioral: Group IPT for Depression + TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months
Measured: 3 Months from Baseline
Secondary outcomes (6)
Change from Baseline in Suicidality at 3 Months
Suicidality as measured by the Beck Scale for Suicide Ideation.
Measured: 3 Months from Baseline
Change from Baseline in In-Prison Functioning at 3 Months
In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)
Measured: 3 Months from Baseline
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months
Measured: 6 Months from Baseline
Change from Baseline in Suicidality at 6 Months
Suicidality as measured by the Beck Scale for Suicide Ideation.
Measured: 6 Months from Baseline
Change from Baseline in In-Prison Functioning at 6 Months
In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)
Measured: 6 Months from Baseline
Cost-effectiveness
Cost-effectiveness based on costs of IPT and TAU, improvements in HRSD scores, LIFE scores, and cost-offsets, including medical costs, programs completed, fewer fights, fewer suicide attempts, and reduced length of incarceration due to more "good time."
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 181 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
- NCT01685294
- Sponsor's protocol ID
- 1R01MH095230-01
- Other IDs
- R01MH095230
- Status last verified
- Jan 2016
- First submitted
- 29 Aug 2012
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson JE, Hailemariam M, Zlotnick C, Richie F, Wiltsey-Stirman S. Analysis of implementation processes in a hybrid effectiveness-implementation trial of interpersonal psychotherapy (IPT) for major depressive disorder in prisons: Training, supervision, and recommendations. PLoS One. 2024 May 14;19(5):e0288182. doi: 10.1371/journal.pone.0288182. eCollection 2024.
PubMed 38743716Felton JW, Hailemariam M, Richie F, Reddy MK, Edukere S, Zlotnick C, Johnson JE. Preliminary efficacy and mediators of interpersonal psychotherapy for reducing posttraumatic stress symptoms in an incarcerated population. Psychother Res. 2020 Feb;30(2):239-250. doi: 10.1080/10503307.2019.1587192. Epub 2019 Mar 11.
PubMed 30857489Johnson JE, Stout RL, Miller TR, Zlotnick C, Cerbo LA, Andrade JT, Nargiso J, Bonner J, Wiltsey-Stirman S. Randomized cost-effectiveness trial of group interpersonal psychotherapy (IPT) for prisoners with major depression. J Consult Clin Psychol. 2019 Apr;87(4):392-406. doi: 10.1037/ccp0000379. Epub 2019 Feb 4.
PubMed 30714749
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
- Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression
- ClinicalTrials.gov ID
- NCT01685294
- Acronym / sponsor ID
- 1R01MH095230-01
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder (MDD), Suicidality, Incarcerated Populations, Prisons, Interpersonal Psychotherapy (IPT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Sep 2012 (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.
This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.
Detailed description
The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment in criminal justice settings by conducting a fully-powered randomized effectiveness study that collects pilot implementation data, including cost-effectiveness data. Group IPT will be compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD from 4 institutions, allowing us to explore gender effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | –Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc. |
| Group Interpersonal Psychotherapy (IPT) for Depression + TAU | Experimental | Behavioral: Group IPT for Depression + TAUParticipants will receive Group IPT for Depression + TAU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet all DSM-IV criteria for primary (non-substance induced) major depressive disorder
- Expectation of at least 6 months of incarceration at baseline interview
- Incarcerated for at least 4 weeks
Key exclusion criteria (5 listed)
- Lifetime:
- Are imminently suicidal
- Cannot understand English well enough to understand the consent form or assessment instruments when read aloud
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 IPT for Depression + TAUInterpersonal psychotherapy (IPT) will be administered in 20 group 90-minute sessions over 10 weeks and 4 individual sessions (before group starts, in the middle of the group, at the end of the group, and one month after the group ends). These sessions will focus on improving your relationships with others, building healthy relationships, setting goals, and increasing coping skills. Additionally, participants will receive standard prison mental health treatment, individual therapy, medication, etc. | Behavioural | Group Interpersonal Psychotherapy (IPT) for Depression + TAU |
Primary outcome
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months
Time frame: 3 Months from Baseline
6 secondary outcomes
Change from Baseline in Suicidality at 3 Months
Time frame: 3 Months from Baseline
Change from Baseline in In-Prison Functioning at 3 Months
Time frame: 3 Months from Baseline
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months
Time frame: 6 Months from Baseline
Change from Baseline in Suicidality at 6 Months
Time frame: 6 Months from Baseline
Change from Baseline in In-Prison Functioning at 6 Months
Time frame: 6 Months from Baseline
Cost-effectiveness
Time frame: 6 months post-baseline
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.
- Derived from this study: PubMed 38743716Johnson JE, Hailemariam M, Zlotnick C, Richie F, Wiltsey-Stirman S. Analysis of implementation processes in a hybrid effectiveness-implementation trial of interpersonal psychotherapy (IPT) for major depressive disorder in prisons: Training, supervision, and recommendations. PLoS One. 2024 May 14;19(5):e0288182. doi: 10.1371/journal.pone.0288182. eCollection 2024.
- Derived from this study: PubMed 30857489Felton JW, Hailemariam M, Richie F, Reddy MK, Edukere S, Zlotnick C, Johnson JE. Preliminary efficacy and mediators of interpersonal psychotherapy for reducing posttraumatic stress symptoms in an incarcerated population. Psychother Res. 2020 Feb;30(2):239-250. doi: 10.1080/10503307.2019.1587192. Epub 2019 Mar 11.
- Derived from this study: PubMed 30714749Johnson JE, Stout RL, Miller TR, Zlotnick C, Cerbo LA, Andrade JT, Nargiso J, Bonner J, Wiltsey-Stirman S. Randomized cost-effectiveness trial of group interpersonal psychotherapy (IPT) for prisoners with major depression. J Consult Clin Psychol. 2019 Apr;87(4):392-406. doi: 10.1037/ccp0000379. Epub 2019 Feb 4.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group IPT for Depression + TAU in people with Major Depressive Disorder, run by Brown University at 5 sites 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 3 inclusion and 5 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 5 sites 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.
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?
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months (time frame: 3 Months from Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685294, which also lists 3 linked publications.
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.