Clinical trial NCT00942721: Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression
Official title: Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postpartum Depression
Keywords: Web-based Intervention
CBT Treatment
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-07-21
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will develop and test a Web-based program to treat women with postpartum depression.

Detailed description: After a woman gives birth, she will often feel anxious, depressed, or upset. For most women, these feelings go away within a week of giving birth, but for some, postpartum depression (PPD) can develop. PPD involves long-term, more severe feelings of anxiety, depression, and despair that impair normal functioning. Untreated PPD threatens both the mental health of mothers and the development of their infants, but many cases go untreated. This may be because of the stigma of mental health treatment, limited availability of programs, cost of treatment, or difficulty finding the time to schedule trips out of the home. Treatment through a Web-based program addresses all these concerns by providing a private, cost-efficient program available anywhere with computer access. This study will develop and test a Web-based version of cognitive behavioral therapy (CBT) to treat women with PPD to determine its feasibility and acceptability.

Participation in this study will last 3 months. All participants will be offered a Web-based version of CBT for PPD. The CBT program will include guided behavioral strategies for dealing with depression, online videos of women who have used these strategies, Web forums in which participants can ask questions of peers and experts, and periodic phone coaching. The program will last 6 weeks. All participants will complete assessments at baseline, post-treatment, and 3-month follow-up. Safety monitoring questionnaires will also be completed at Weeks 2 and 4 of treatment. Assessments will include clinical interviews and questionnaires related to the following: health; depression; demographics; maternal skills, stress, and self-efficacy; Internet use, experience, and self-efficacy; behavioral self-efficacy; and program acceptability.

Eligibility criteria: Inclusion Criteria:

* Within 6 months postpartum
* Home access to the Internet
* Use of personal e-mail
* Score from 12 to 20, inclusive, on the Edinburgh Postnatal Depression Scale
* Diagnosed as having postpartum depression

Exclusion Criteria:

* Current diagnosis of substance abuse, bipolar disorder, or psychotic depression
* Currently receiving treatment for depressive symptoms, including antidepressant medication or psychotherapy
* Currently has suicidal intentionality, lethality, access to means, and history of suicide attempts

Primary outcomes:
measure: Acceptability and feasibility of the Web-based treatment program for women with postpartum depression
timeFrame: Measured 3 and 6 months postpartum
measure: Clinical utility of the program in ameliorating postpartum depression symptoms
timeFrame: Measured 3 and 6 months postpartum
Secondary outcomes:
measure: Women's characteristics that moderate the impact of the program
timeFrame: Measured 3 and 6 months postpartum
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
city: Heidelberg Heights
country: Australia
facility: University of Melbourne
state: Victoria
Study officials:
affiliation: Oregon Research Institute
name: Brian G. Danaher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Melbourne
name: Jeannette Milgrom, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Scott Stuart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danaher BG, Milgrom J, Seeley JR, Stuart S, Schembri C, Tyler MS, Ericksen J, Lester W, Gemmill AW, Lewinsohn P. Web-Based Intervention for Postpartum Depression: Formative Research and Design of the MomMoodBooster Program. JMIR Res Protoc. 2012 Nov 22;1(2):e18. doi: 10.2196/resprot.2329.
citation: Danaher BG, Milgrom J, Seeley JR, Stuart S, Schembri C, Tyler MS, Ericksen J, Lester W, Gemmill AW, Kosty DB, Lewinsohn P. MomMoodBooster web-based intervention for postpartum depression: feasibility trial results. J Med Internet Res. 2013 Nov 4;15(11):e242. doi: 10.2196/jmir.2876.