Alma: The Alma Program Pilot RCT

Topic:

Co-designing and investigating a peer-delivered program, Alma, designed to support new and expectant mothers experiencing depression with the skills of Behavioral Activation (BA).

Study Status

Ongoing

Project Team

Principal Investigators: Sona Dimidjian, PhD

Current Team:  Sherryl Goodman, Ph.D.; Sam Hubley, PhD; Robert Gallop, PhD; Rachel Vanderkruik, PhD; Joey Levy, MA; Anahí Collado, PhD; Laurel Hicks, PhD

Community Partners: Kaiser Permanente Colorado: Arne Beck, PhD; Debra Ritzwoller, PhD; Jennifer Boggs, PhD; Angela Plata; Mark Gray; Carsie Nyirenda

Alignment with Crown Institute Vision

This project reflects the Crown Institute’s commitment to supporting the wellbeing of children by caring for the adults who care for them. The Institute’s work centers on practical, community-engaged research that strengthens families and supports mental health across the lifespan. Our study advances this mission by co-designing and investigating a peer-delivered program, Alma, designed to support new and expectant mothers experiencing depression with the skills of Behavioral Activation (BA).

Background & Context

Untreated depression during pregnancy can have enduring adverse consequences and correlates for women and their children. Although antidepressant medication is the most frequently provided intervention for depression during pregnancy, it is efficacious only as long as it is taken, and when pregnant women discontinue antidepressant medication, they are at risk for relapse. Pregnant women prefer both non-pharmacological treatment and access to such treatment in the obstetric setting; however, access to psychotherapy, especially in obstetric settings, is highly limited. As such, pregnant women and their healthcare providers continue to face the choice between antidepressant medication and no treatment, which is unacceptable, particularly given that efficacious behavioral interventions for depression exist. Further, knowledge that pregnant women consult informal more than professional sources has not yet informed service delivery. The skills of BA are comparable in efficacy to antidepressant medication in the general population and superior to usual care among pregnant women in the reduction of depression, anxiety, and stress, but such skills are not accessible to most pregnant women. Thus, the proposed project has the potential for high impact in solving a major gap in current healthcare, thereby impacting the health of women and their offspring.

Primary Aims

This study aimed to refine the lay counselor BA model for dissemination by peers in obstetric settings. Building on focus group methods used with perinatal women by consultants Patel and Rahman, we examined patient (n = 25) and stakeholder (n = 50) input to inform the use of accessible and engaging language, preferred peer and patient characteristics, frequency, duration, and length of peer BA sessions, and contextual issues such as an emphasis on family involvement and infant well-being to promote engagement. We developed protocols for peer delivery and web-based training, supervision, and fidelity monitoring tools. 

Aim 2: We aimed to test the BA peer delivery web-based training, supervision, and fidelity monitoring tools. We aimed tod train peers (n = 5) and evaluate outcomes in the context of a pre-post open trial with depressed pregnant women (n = 10).  

Aim 3: We aimed to conduct a pilot randomized effectiveness trial, comparing peer delivered BA with usual care (using Phase 2 trained peers) for pregnant women with depression (N=50). 

Research Methods

We used a three-phase, mixed-method participatory research design. In Phase 1, we conducted focus groups (N = 20) and an online survey (N = 118) to guide the design of Alma, the peer-delivered BA program. In Phase 2, we co-designed the program and training materials with five peers who delivered the program to pregnant depressed women (N = 10). In Phase 3, we conducted a pilot randomized controlled trial (N = 27), comparing the peer-delivered BA program to treatment-as-usual to evaluate acceptability (completion, satisfaction, working alliance), feasibility (delivery quality), and depression symptom severity change.

Key Findings & Publications /
Presentations

This pilot trial demonstrated the acceptability, feasibility, and preliminary indicators of promise in depressive severity reduction of a co-designed, peer-delivered BA program for depressed perinatal women. Manuscripts from this study are forthcoming.

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References

Stein A, Pearson RM, Goodman SH, et al. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014;384(9956):1800-1819. 

Ko JY, Farr SL, Dietz PM, Robbins CL. Depression and treatment among U.S. pregnant and nonpregnant women of reproductive age, 2005-2009. Journal of Women's Health. 2012;21(8):830-836. 

O'Mahen HA, Flynn HA. Preferences and perceived barriers to treatment for depression during the perinatal period. J Womens Health (Larchmt). 2008;17(8):1301-1309. 

Goodman JH. Women's Attitudes, Preferences, and Perceived Barriers to Treatment for Perinatal Depression. Birth-Issues in Perinatal Care. 2009;36(1):60-69. 

Battle CL, Salisbury AL, Schofield CA, Ortiz-Hernandez S. Perinatal antidepressant use: Understanding women's preferences and concerns. J Psychiatr Pract. 2013;19(6):443-453. 

Henshaw E, Sabourin B, Warning M. Treatment-seeking behaviors and attitudes survey among women at risk for perinatal depression or anxiety. J Obstet Gynecol Neonatal Nurs. 2013;42(2):168-177. 

ACOG. Screening for perinatal depression: Committee Opinion. American College of Obstetricians and Gynecologists;2015.

Marcus SM, Flynn HA, Blow FC, Barry KL. Depressive symptoms among pregnant women screened in obstetrics settings. J Womens Health. 2003;12(4):373-380. 

Dietz PM, Williams SB, Callaghan WM, Bachman DJ, Whitlock EP, Hornbrook MC. Clinically identified maternal depression before, during, and after pregnancies ending in live births. Am J Psychiatry. 2007;164(10):1515-1520. 

Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295(5):499-507.