Preventing Perinatal Depression (PRE-D): Developing Tools and Interventions

Study ID
STU 102010-015

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Lauren Singer
214-648-0176
lauren.singer@utsouthwestern.edu

Principal Investigator
Robin Jarrett

Summary

This is a randomized (1:1) comparison of two systems for monitoring depressive symptoms in women attempting to conceive or who are pregnant, and have a history of MDD.
Cell #1xC-aiM: Patients randomized to C-aiM will attend 6 clinic visits (either individually or in groups of 2-4 women) spread over 6-8 weeks as well as the longitudinal montioring. if scheduling is problematic, online or telephone sessions can be used. Clinician-assisted internet Monitoring (C-aiM) has four components: 1) scheduled evaluation conducted by a blind evaluator using web-conferencing and/or telephone every four months, 2) self-monitoring by the participant through the PRe-D website, protected email (e.g., SeCuReMaiL), or ReDCap, 3) continuous follow-up by a Clinician Guide who contacts the participant if she does not complete the assessment or if she requests assistance of any type, 4) triggered evaluations by any research staff, clinician, or blind evaluator.
Cell #2xC-aiM + P-CT: Patients randomized to C-aiM + P-CT will attend 6 clinic visits (either individually or in groups of 2-4 women) spread over 6-8 weeks but receive assigned tasks (i.e., within Preventive Cognitive Therapy) to assist in preventing depression. if scheduling is problematic, online or telephone sessions can be used. Then, live web-conferencing sessions to include video feed (or telephone communication as needed) will be conducted as a required part of P-CT, and could be conducted if a scheduled session is needed when an office visit is difficult to schedule or if an immediate issue needs to be addressed. This cell includes a chat window with the cognitive therapist (a psychologist who provides cognitive therapy) and/or clinician guide. Preventive Cognitive Therapy (P-CT) begins after participants have completed 6 sessions on Cognitive Therapy Fundamentals (CT-F). Cognitive Therapy-Fundamentals (CT-F) teaches the fundamentals of CT in order to reduce depressive symptoms and will be delivered by experienced cognitive therapists. During CT-F the patient will identify 1-2 skills from the 5 modules which she found the most useful in reducing her emotional distress. These skills will be emphasized in P-CT. P-CT focuses on: a) preventing depressive relapse by teaching women to identify and cope with situations and symptoms associated with cognitive, interpersonal, or emotional vulnerabilities, with particular attention to cognitions regarding pregnancy and parenting; b) continued practice using CT fundamental self-help skills c) dealing with new crises as they arise. Symptom flurries are addressed with symptom-reducing cognitive-behavioral techniques; the more symptomatic the patient, the more structured the therapist. Method of delivery will be internet video streaming (assisted by telephone communication as needed), internet-based texting, uploads, and downloads of information and homework via our protected website, protected email (e.g., SeCuReMaiL), or ReDCap. The patients randomized to P-CT will also participate in all aspects of C-aiM described above. The same cognitive therapist conducts CT-F and P-CT. P-CT consists of 10 (50-60 minute) sessions occurring over 8 months (either individually or in small groups of 2-4 women). The first 4 sessions occur every other week and the last 6 session occur monthly.
outcomes
Safety: any study-related event that poses possible harm or distress to the participant, her fetus or baby, or compromises her confidentiality will be defined as an adverse event.
Feasibility: We will assess attendance and completion rates of the approximately 20-35 randomized patients over 8 months of C-aiM or P-CT, as assigned.
Tolerability and acceptability: Participants, staff, and providers will provide qualitative and quantitative feedback on all elements of C-aiM and P-CT. at exit, participants and study personnel will complete an exit interview to explore ways to improve the project and products.

Participant Eligibility

-Females aged 18-45 years
-Actively attempting conception (off birth control/sexually active) or pregnant
-Has access to a computer or is willing to use lab computer
-At least one previous episode of DSM-IV diagnosis of Major Depressive Disorder (MDD), treated or untreated, of 4 weeks duration
-Does not met criteria for current DSM-IV MDD and the HRSD-17 score is less than or equal to 12 at diagnostic evaluation and randomization
-Medically healthy according to structured medical history
-Is under care of OB/GYN or other health care provider
-Able to provide informed consent