None listed
Conditions
Brief summary
Every year, Postnatal Depression (PND) affects at least 40,000 women in Australia. It has serious consequences for maternal mental health and infant development. Poor uptake of clinic-based treatments suggests a Web-based treatment can play a major role in tackling this public health problem, particularly as an increasing number of women will be identified as depressed through the National Perinatal Depression Initiative. Major barriers to treatment include stigma; poor access; treatment costs, and scheduling trips outside of the home with a new baby. We have developed an interactive, Web-based treatment targeted to women with PND and now aim to evaluate its efficacy compared to traditional face-to-face cognitive behavioural therapy in a 3-group randomised controlled trial. The main aims are to: (a) evaluate the efficacy of the program with respect to the primary outcomes of depressive episode remission, and amelioration of depression and anxiety symptoms; and (b) to evaluate the efficacy of the MumMoodBooster program with respect to secondary outcomes including the putative CBT change mechanisms, perceived stress, and marital functioning. A total of 210 mothers will be recruited via our well-developed relationship with Maternal and Child Health Centres in Victoria. In addition, the study will be advertised widely, targeting rural women (Internet e.g. beyondblue, local newspapers, magazines), and appropriate health professionals/services (e.g., GPs, PaNDA, etc) will be contacted and encouraged to screen and/or refer women with suspected PND. Potential recruits will be screened with the Edinburgh Postnatal Depression Scale (EPDS) and those scoring 13-20, inclusive, on the EPDS will be considered for further involvement. Following referral, women will be contacted by a member of the research team to assess eligibility and explain the study or will complete pre-screening measures online. Inclusion criteria are: (a) EPDS score 13-20, (b) 18 years and older, (c) ability to understand English, (d) 6 weeks to 1 year postpartum, (e) home Internet access, (f) familiarity with the Internet and e-mail, (g) able/willing to give informed consent, (h) diagnosis of a major and minor depressive episode using the Structured Clinical Interview for DSM-IV (SCID). Exclusion criteria are: (a) risk of suicide, (b) current substance abuse, manic/hypomanic symptoms or depression with psychotic features meeting DSM-IV criteria; or c) current treatment for depression (medication or psychotherapy). Following contact with women via phone, a Participant Information and Consent Form will be sent in the mail and potential participants will be asked to sign it and return it to the researchers. An alternative online pre-screening and consent process is also in place. A clinical assessment will then be completed by phone and participants will be asked to complete baseline, pre-treatment questionnaires by visiting the secure website. Women will then be randomised in a 1:1:1 ratio to Web-based or face-to-face CBT (n = 70 in each), or to treatment as usual (n = 70), using a pre-generated permuted blocks allocation schedule. Post-test data will be collected at 9 weeks post-enrolment and follow-up data at three months post-treatment.
Interventions
1] MumMoodBooster is a Web-based treatment targeted to women with postnatal depression, completed over 9 weeks, with low-intensity support from a telephone coach. The MumMoodBooster Web-based intervention consists of a series of six sequential interactive sessions (30 min sessions) based on Cognitive Behaviour Therapy. These are designed to be completed over 9 weeks, which allows women to schedule sessions to fit their own needs and to re-visit previously completed material. Additionally, intervention participants will be phoned weekly (up to 30 minutes) by a phone coach who will monitor their progress and encourage practice of the recommended strategies. Participants will also have access to a web support forum and a significant amount of content to view at any time in the form of companion library articles. 2] Face-to-face CBT: Women in this condition will receive weekly individual CBT therapy (approximately 1 hour session) with an experienced psychologist using an individualised version of our Getting Ahead of Postnatal Depression program. Within the 9-week program a detailed manual is followed that includes 9 sessions with each woman (Milgrom et al., 1999). The program uses a CBT approach and addresses maternal mood (depression and anxiety), behavioural activation, cognitive strategies, self-esteem, relaxation (“relax on the run”), getting support and dealing with partner issues. In the Web-based intervention adherence to treatment (completion of modules) will be monitored online and via telephone coaching calls. In the face-to-face CBT group, therapists will follow a manualised protocol and will keep detailed session attendance records including details of content covered in each weekly (1 hour) session.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion criteria are: (a) EPDS score 13-20, (b) 18 years and older, (c) ability to understand English, (d) 6 weeks to 1 year postpartum, (e) home Internet access, (f) familiarity with the Internet and e-mail, (g) able/willing to give informed consent, (h) diagnosis of a major and minor depressive episode using the Structured Clinical Interview for DSM-IV.
Exclusion criteria
Exclusion criteria are: (a) risk of suicide, (b) current substance abuse, manic/hypomanic symptoms or depression with psychotic features meeting DSM-IV criteria; or c) current treatment for depression (medication or psychotherapy).