- What is the PRE-D project about?
- How do participants benefit from the PRE-D study?
- How does the study work? What will I be doing?
- How can I become a participant?
- Will I be eligible if I am currently depressed?
- What is depression?
- What if I start feeling depressed again?
- What do I do in case of an emergency (i.e., my physical health is threatened)?
- How do I contact the clinic conducting this study?
- I am experiencing technical problem. Whom do I contact?
- What if I don't have a computer?
- I am a doctor and would like to refer some of my patients to the PRE-D study. How do I proceed?
What is the PRE-D study about?
Along with their clinicians, such women need convenient methods to detect and prevent depression. This study is being done to evaluate the safety, feasibility, and acceptability of new methods to:
- Monitor symptoms of depression by means of Clinician-Assisted Internet Monitoring (C-AIM) alone, or
- Prevent symptoms of depression through Preventive Cognitive Therapy (PRE-CT) plus Clinician-Assisted Internet Monitoring (C-AIM).
Future studies may test how good these new methods are for identifying symptoms and keeping women from becoming depressed again while pregnant or trying to get pregnant, and/or during the year after the baby is born (postpartum depression). This small study is to develop such tools and get feedback from users.
How do participants benefit from the PRE-D study?
If you agree to take part in this study, there may or may not be direct benefits to you. The researchers cannot guarantee that you will benefit from participation in this research or that you will avoid depression. However, through your study participation, you will receive a higher level of monitoring of your depressive symptoms than is standard in our community for women not currently depressed, but with a history of depression.
We hope the study information will benefit women who have a history of depression and who want to maintain their recovery while they attempt conception, during their pregnancy, or after giving birth. Information gained from this research could lead to better treatment for depression before, during, and after pregnancy.
How does the study work? What will I be doing?
Study activities will include clinic appointments, completing questionnaires in person at the clinic and later online (some sessions are videotaped), and interacting with research personnel and clinicians both in person and through the internet as described below. If you are eligible for this study, you will be assigned randomly to receive either Clinician-Assisted Internet Monitoring (C-AIM) or C-AIM plus Preventive Cognitive Therapy (P-CT).
- The purpose of Clinician-Assisted Internet Monitoring (C-AIM) is to allow clinicians and patients to monitor depressive symptoms and patient safety in real time outside the clinic and involves four components:
- Scheduled evaluations conducted by an evaluator using video-conferencing every four months.
- Self-monitoring by you, the patient, through the PRE-D website.
- Continuous follow-up by a Clinician Guide who contacts you if you do not complete the assessment or if you request assistance of any type.
- Evaluations as needed by any research staff, clinician, or blind evaluator.
- Preventive Cognitive Therapy (P-CT) focuses on:
- Preventing depressive relapse by teaching you to identify and cope with situations and symptoms associated with cognitive, interpersonal, or emotional vulnerabilities, with particular attention to cognitions regarding pregnancy and parenting.
- Continued practice using CT basic self-help skills.
- Dealing with new crises as they arise.
Our experienced clinicians will be prepared and glad to assist participants along the way.
How can I become a participant?
If you want to be a participant in our study please contact the Psychosocial Research and Depression Clinic. A member of our research team will be glad to help you.
You may be eligible for this study if you:
- Are age 18 to 45.
- Are planning to get pregnant or are pregnant.
- Are not currently depressed.
- Have a history of depression and are concerned about its return.
- Have access to a health care provider.
- Allow us to work closely with your provider.
- Have access to a computer with internet access or be willing to use a computer in our clinic.
Will I be eligible if I am currently depressed?
No, but you might only show some depressive symptoms yet not have a major depressive episode. Contact us for more information – we'll be glad to help.
What is depression?
According to the DSM-IV, a manual used to diagnose mental disorders, one or both of the following symptoms need to be present for at least two weeks and interfere with normal functioning:
- Depressed mood during most of the day and/or
- Markedly diminished interest or pleasure in almost all activities nearly every day
Additionally, for a diagnosis of depression, five or more of the following symptoms have to be present during the same 2-week period:
- Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feels sad or empty) or observation made by others (e.g., appears tearful).
- Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day
- Significant weight loss when not dieting or weight gain, or decrease or increase in appetite nearly every day
- Insomnia or hypersomnia nearly every day
- Psychomotor agitation or retardation nearly every day
- Fatigue or loss of energy nearly every day
- Feelings of worthlessness or excessive or inappropriate guilt nearly every day
- Diminished ability to think or concentrate, or indecisiveness, nearly every day
- Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide
For additional information, please see the National Institute of Mental Health (NIMH) website.
Source: American Psychiatric Association. (2000). Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.). Washington, DC: Author.
What if I start feeling depressed again?
If you are not currently enrolled in the PRE-D study, contact your primary care physician. If it is an emergency, call 911 or go to the nearest emergency room.
If you are already enrolled in the PRE-D study, please contact the Psychosocial Research and Depression Clinic and work with your Clinician Guide to update your Individualized Action Plan (a plan that helps you remember useful action steps).
What do I do in case of an emergency (i.e., my physical health is threatened)?
In case of emergency, call 911 or go to the nearest emergency room.
How do I contact the clinic conducting this study?
Visit the Contact Us page for more information.
What if I don't have a computer?
Not having a computer should not keep you from being part of this study and taking advantage of this new approach if you are worried about your depression returning. The Psychosocial Research and Depression Clinic will allow you to use its computers onsite, but you will need to come into the research clinic frequently to do so.
I am a doctor and would like to refer some of my patients to the PRE-D study. How do I proceed?
If you are interested in this project and are thinking about referring some of your patients, please contact us.
We will screen women for study eligibility who are:
- Aged 18 to 45.
- Actively pursuing conception or pregnant.