Postpartum depression interpersonal psychotherapy trial
| ISRCTN | ISRCTN88987377 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88987377 |
| Secondary identifying numbers | MCT-82332 |
- Submission date
- 30/03/2007
- Registration date
- 30/03/2007
- Last edited
- 10/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Postpartum depression (PPD) is a type of depression that many women experience after having a baby. Women who have suffered from PPD are twice as likely to experience future episodes of depression over a 5-year period. PPD can affect mother-infant interactions and lead to child neglect or abuse and marital stress resulting in separation or divorce. Mother and infant deaths are rare but real consequences of PPD. Effective treatment of PPD is needed to not only help the mother but also to prevent these consequences. Antidepressant medication, cognitive behavioural therapy and interpersonal psychotherapy (IPT) are effective treatments for general depression. However, mothers are often reluctant to take antidepressants due to concerns about their transmission in breast milk or potential side effects. Although there is evidence that antidepressants are relatively safe for breastfed infants, it is important that non-drug treatments are tested for use with mothers. IPT may be an effective treatment for PPD. IPT is a brief manual-based psychotherapy that addresses relationship issues in depression. Generally, IPT consists of 12 to 20 weekly sessions lasting 50 to 60 minutes that may be provided by psychiatrists and a range of non-medical health professionals, including nurses. Unfortunately, IPT is not widely available, especially in rural and remote areas. To improve access to care, telepsychiatry has been introduced – this involves providing therapy by telephone. The aim of this study is to test the effect of telephone-based IPT on the treatment of PPD.
Who can participate?
Mothers who have had a baby 2 to 24 weeks ago and have PPD
What does the study involve?
Participants are randomly allocated to one of two groups. The intervention group receive usual postpartum care plus the telephone-based IPT. The telephone IPT includes 12 sessions with a highly trained IPT nurse. Each session is 50 minutes long and is scheduled on a weekly basis. The other group receive usual postpartum care. All participants are telephoned by one of our research nurses after 3, 6 and 9 months to ask about how they are feeling and the healthcare services they have used.
What are the possible benefits and risks of participating?
At the end of the study all participants receive a small token of appreciation. There are no known risks to participants.
Where is the study run from?
University of Toronto (Canada)
When is the study starting and how long is it expected to run for?
September 2007 to February 2013
Who is funding the study?
Canadian Institutes of Health Research (CIHR)
Who is the main contact?
1. Dr Cindy-Lee Dennis (cindylee.dennis@utoronto.ca)
2. Melissa Jovellanos (melissa.jovellanos@utoronto.ca)
Contact information
Scientific
University of Toronto (Canada)
Lawrence S. Bloomberg Faculty of Nursing
130-155 College Street
Toronto
Ontario
M5T 1P8
Canada
| Phone | +1 (0)416 946 8608 |
|---|---|
| cindylee.dennis@utoronto.ca |
Public
University of Toronto
Lawrence S. Bloomberg Faculty of Nursing
130-155 College Street
Toronto
M5T 1P8
Canada
| Phone | +1 (0)416 946 0929 |
|---|---|
| melissa.jovellanos@utoronto.ca |
Study information
| Study design | Multicentre two-arm randomised parallel trial with study investigator, caregiver, outcome assessor, and data analyst blinding |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial to evaluate the effectiveness of telephone-based interpersonal psychotherapy for the treatment of postpartum depression |
| Study objectives | Primary question: What is the effect of telephone-based Interpersonal Psychotherapy (IPT) by trained nurses on Postpartum Depression (PPD) at 12 weeks post-randomisation (i.e., immediately post-treatment for mothers in the intervention group)? Secondary questions: What is the effect of telephone-based IPT by trained nurses on: 1. PPD at 24 and 36 weeks post-randomisation (i.e., 12 and 24 weeks post-treatment for mothers in the intervention group)? 2. Depressive symptomatology at 12, 24, and 36 weeks post-randomisation? 3. Anxiety at 12, 24, and 36 weeks post-randomisation? 4. Social functioning at 12, 24, and 36 weeks post-randomisation? 5. Health service utilisation from randomisation to 36 weeks post-randomisation? Amended as of 12/06/2009: The following secondary question has been amended: 4. Attachment at 12, 24, and 36 weeks post-randomisation? The following secondary question has been added: 6. Relationship quality and adjustment at 12, 24, and 36 weeks post-randomisation? Other research questions: 1. What are the cost implications of IPT versus usual care, from a societal perspective? 2. What are mothers evaluations of their IPT experience? 3. What are nurses evaluations of their experience in providing IPT? 4. What are nurses reports of the type and intensity of their IPT activities? |
| Ethics approval(s) | 1. Health Sciences 1 Research Ethics Board of the University of Toronto (Canada), 13/07/2006, ref: 17788 2. The Huron Country Health Unit (Canada), 12/10/2006 3. Health Sciences 1 Research Ethics Board of the University of Toronto (Canada) renewal granted 08/08/2007, expiry: 12/07/2008, ref: 20766 4. Health Sciences 1 Research Ethics Board of the University of Toronto (Canada) renewal granted 15/08/2008, expiry: 12/07/2009, ref: 22629 |
| Health condition(s) or problem(s) studied | Postpartum depression |
| Intervention | Amended as of 12/06/2009: Interpersonal psychotherapy: one-hour session of telephone-based interpersonal psychotherapy every week for 12 weeks (i.e., or a maximum of 16 sessions for up to 16 weeks per participant) Standard care: what is usually provided by the health region for mothers identified with depressive symptomatology. Initial information at time of registration: Interpersonal psychotherapy: one-hour session of telephone-based interpersonal psychotherapy every week for 12 weeks beginning within 48 to 72 hours of trial randomisation. Standard care: what is usually provided by the health region for mothers identified with depressive symptomatology. |
| Intervention type | Other |
| Primary outcome measure | Postpartum depression: 12 weeks post-randomisation (immediately post-treatment for mothers in the intervention group). |
| Secondary outcome measures | Amended as of 12/06/2009: The following point was amended to: 4. Attachment measured with the Experiences in Close Relationships-Revised (self-report measure): 12, 24, and 36 weeks post-randomisation The following point was added: 6. Relationship quality and adjustment with the Dyadic Adjustment Scale (self-report measure): 12, 24, and 36 weeks post-randomisation Initial information at time of registration: 1. Postpartum depression (clinical diagnostic interview): 24 and 36 weeks post-randomisation (i.e., 12 and 24 weeks post-treatment for mothers in the intervention group 2. Depressive symptomatology (self-report measure): 12, 24, and 36 weeks post-randomisation 3. Anxiety measured with the Spielberger State-Anxiety Inventory (self report measure): 12, 24, and 36 weeks post-randomisation 4. Social functioning measured with the Social Adjustment Scale-Self Report (self report measure): 12, 24, and 36 weeks post-randomisation 5. Health service utilisation measured with a slightly modified version of the Health Service Utilisation and Cost of Care Questionnaire (self-report measure): from randomisation to 36 weeks post-randomisation |
| Overall study start date | 01/09/2007 |
| Completion date | 28/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 240 |
| Total final enrolment | 241 |
| Key inclusion criteria | 1. Live birth 2. Infant discharged from hospital 3. Mother between two and 24 weeks postpartum 4. Clinical diagnosis of major depression using the Structured Clinical Interview for Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) 5. Understands spoken English |
| Key exclusion criteria | Amended as of 12/06/2009: The following point was amended to: 4. Chronic depression (episode length greater than 2 years) The following point was added: 5. Current or past manic depression Initial information at time of registration: 1. Current use of antidepressant medication 2. Currently receiving any form of psychotherapy administered by a trained professional 3. Active suicidal or self-harm thoughts 4. Chronic depression (episode length greater than 2.5 years) |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
M5T 1P8
Canada
Sponsor information
University/education
27 King's College Circle
Toronto
Ontario
M5S 1A1
Canada
| Phone | +1 (0)416 978 2163 |
|---|---|
| audrey.cheung@utoronto.ca | |
| Website | http://www.utoronto.ca/ |
"ROR" |
https://ror.org/03dbr7087 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/04/2012 | Yes | No | |
| Results article | results | 01/04/2020 | 10/02/2020 | Yes | No |
Editorial Notes
10/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
07/09/2016: Plain English summary added.
04/10/2011: the overall end date was changed from 30/09/2010 to 28/02/2013.
