Depression During PregnancyNCT01401231
Behavioral Activation for Perinatal Depression
A study testing Behavioral activation psychotherapy in people with Depression During Pregnancy, run by Kaiser Permanente at 1 site in United States.
Trial summary
This pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression During Pregnancy
- What is being tested?
- Behavioral activation psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant PHQ9 Depression Score of 15 or greater Receiving prenatal care at one of the participating sites
Who cannot join
- Known diagnosis of bipolar or psychotic disorder Active substance dependence Immediate risk of self harm Immediate need for inpatient mental health treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression
This pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression.
- Conditions
- Depression During Pregnancy
- Being tested
- Behavioral activation psychotherapy, Usual care
- Keywords
- depression, pregnancy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral activation psychotherapyBehavioural
Up to 10 sessions of behavioral activation psychotherapy delivered in person or by telephone.
Usual careOther
Continued usual care (could include referral for medication or psychotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral activation psychotherapy Receives: Behavioral: Behavioral activation psychotherapy |
| Usual Care | Placebo comparator | Continued care as usual Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ9 Depression Score
Mean PHQ9 depression score 3 months postpartum
Measured: 3 months post-partm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startAug 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 (1)Papers the sponsor has linked to this study.
- Other trials for Depression During PregnancyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), HealthPartners Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401231
- Sponsor's protocol ID
- U19MH092201
- Other IDs
- U19MH092201
- Status last verified
- Oct 2017
- First submitted
- 22 Jul 2011
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dimidjian S, Goodman SH, Sherwood NE, Simon GE, Ludman E, Gallop R, Welch SS, Boggs JM, Metcalf CA, Hubley S, Powers JD, Beck A. A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women. J Consult Clin Psychol. 2017 Jan;85(1):26-36. doi: 10.1037/ccp0000151.
PubMed 28045285
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression
- ClinicalTrials.gov ID
- NCT01401231
- Acronym / sponsor ID
- U19MH092201
- Conditions
- Depression During Pregnancy
- Keywords
- depression, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), HealthPartners Institute
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Jul 2011 (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 pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral activation psychotherapyBehavioral activation psychotherapy |
| Usual Care | Placebo comparator | Other: Usual careContinued care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant PHQ9 Depression Score of 15 or greater Receiving prenatal care at one of the participating sites
Key exclusion criteria (1 listed)
- Known diagnosis of bipolar or psychotic disorder Active substance dependence Immediate risk of self harm Immediate need for inpatient mental health treatment
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 |
|---|---|---|
| Behavioral activation psychotherapyUp to 10 sessions of behavioral activation psychotherapy delivered in person or by telephone. | Behavioural | Behavioral Activation |
| Usual careContinued usual care (could include referral for medication or psychotherapy) | Other | Usual Care |
Primary outcome
PHQ9 Depression Score
Time frame: 3 months post-partm
Mean PHQ9 depression score 3 months postpartum
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 Oct 2017.
- Derived from this study: PubMed 28045285Dimidjian S, Goodman SH, Sherwood NE, Simon GE, Ludman E, Gallop R, Welch SS, Boggs JM, Metcalf CA, Hubley S, Powers JD, Beck A. A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women. J Consult Clin Psychol. 2017 Jan;85(1):26-36. doi: 10.1037/ccp0000151.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral activation psychotherapy in people with Depression During Pregnancy, run by Kaiser Permanente 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 1 inclusion and 1 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 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
PHQ9 Depression Score (time frame: 3 months post-partm). 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 NCT01401231, which also lists 1 linked publication.
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 Oct 2017.