Depressed Mothers in Rural Areas: Web-Facilitated Cognitive Behavioral Treatment (Mom-NetRCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Oregon Research Institute
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01535352
First received: February 14, 2012
Last updated: October 15, 2015
Last verified: October 2015
  Purpose
Low income mothers of young children represent a disadvantaged group who are at exceptional risk for depressive syndromes and who have increasingly limited access to mental health services. The proposed project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral(CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in an recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in the pilot trial will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms.Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.

Condition Intervention
Maternal Care Patterns
Behavioral: Mom-Net
Behavioral: Coach-facilitated Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depressed Mothers in Rural Areas: Web-Facilitated Cognitive Behavioral Treatment

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • PHQ-9 [ Time Frame: 4 months, 16 months, 28 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet-facilitated CBT
Participants in the randomized trial will be 300 mothers of 3-5 year old children recruited through Head Start (HS) classrooms and screened for the presence of major or minor depression. Subsequent to the pre-intervention assessment, participants will be randomized, with an allocation ratio of 1:1, to either the Mom-Net (MN) intervention or facilitated usual care (FUC) condition. Participants in the MN condition will receive the Mom-Net intervention. The Mom-Net program is an internet-facilitated cognitive-behavioral intervention for depression, adapted from the CWDC, and tailored to mothers of young children. Participants in both conditions will receive Booster calls during the follow-up period.
Behavioral: Mom-Net
The Mom-Net intervention is an internet-facilitated cognitive-behavioral intervention for depression, adapted from the CWDC, and tailored to mothers of young children. Mom-Net has several core components: 1. A guided course for self-regulated learning of CBT skills. 2. A system of professional support in which coaches provide weekly 15-20 min phone check-ins (coach calls) in order to encourage and facilitate progress through the intervention and respond rapidly to participant queries and emergencies. In this regard, coaches benefited from: a) a 'behind the scenes" administration page on the website that enabled them to track participants' progress through the intervention and use this information to tailor coaching sessions; and b) an automated system for alerting coaches/supervisors when participants were in crisis. 3. A coach-moderated bulletin board that approximated the social support provided by group administration.
Active Comparator: Coach-facilitated Treatment as Usual
Participants in the FUC condition will receive assistance in accessing mental health interventions through community providers that serve low-income individuals. In order to control for the supportive attention provided to mothers in the MN condition by the weekly coach calls, mothers in the FUC condition will receive weekly check-in calls from research staff during the intervention period. Participants in both conditions will receive Booster calls during the follow-up period.
Behavioral: Coach-facilitated Treatment as Usual
Participants in the facilitated usual care (FUC) condition will receive assistance in accessing mental health interventions through community providers that serve low-income individuals. In order to control for the supportive attention provided to mothers in the MN condition by the weekly coach calls, mothers in the FUC condition will receive weekly check-in calls from research staff during the intervention period. Participants in both conditions will receive Booster calls during the follow-up period.

Detailed Description:
The project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral (CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in a recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in this project will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms. Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mother of 3-5 year old child(ren)
  • Reside in rural community, as defined by RUCA
  • Meet DSM IV criteria for major or minor depression based on PHQ-9

Exclusion Criteria:

  • Cannot comprehend spoken English
  • Being treated for depression at intake
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535352

Locations
United States, Oregon
Options Counseling Services of Oregon Not yet recruiting
Eugene, Oregon, United States, 97401
Contact: Stephen Allen, PhD    541-687-6983    stevea@options.org   
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact: Lisa Sheeber, PhD    541-484-2123 ext 2139    lsheeber@ori.org   
Sponsors and Collaborators
Oregon Research Institute
  More Information

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01535352     History of Changes
Other Study ID Numbers: R01MH091199-02 
Study First Received: February 14, 2012
Last Updated: October 15, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 23, 2016