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

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Oregon Research Institute

Status

Completed

Conditions

Maternal Care Patterns

Treatments

Behavioral: Coach-facilitated Treatment as Usual
Behavioral: Mom-Net

Study type

Interventional

Funder types

Other

Identifiers

NCT01535352
R01MH091199-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

266 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

266 participants in 2 patient groups

Internet-facilitated CBT
Experimental group
Description:
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.
Treatment:
Behavioral: Mom-Net
Coach-facilitated Treatment as Usual
Active Comparator group
Description:
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.
Treatment:
Behavioral: Coach-facilitated Treatment as Usual

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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