Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
Condition: Post Partum Depression; Perinatal Depression; Post Partum Anxiety; Perinatal Anxiety
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This protocol will test the hypothesis that Acceptance and Commitment Therapy (ACT) is
      effective in reducing anxiety and depressive symptoms during the perinatal and postpartum
      periods. Participants should expect their participation in the study to last 9-12 months.
    

Detailed description: 
      The study's major theme is "to examine the efficacy of a brief Acceptance and Commitment
      Therapy (ACT) intervention in treating perinatal anxiety symptoms, as compared to a
      supportive control condition."

      The perinatal and postpartum periods are known to be a vulnerable time for the development of
      mental health symptomatology, with approximately 7% of women developing postpartum depression
      in the first three months following childbirth. One known predictor of postpartum depression
      is perinatal anxiety and distress. The impact of postpartum depression extends beyond the
      mother, whose distress and daily functioning are affected, with adverse effects on infant
      development and care. The need for interventions and preventive interventions has been widely
      indicated for over two decades.

      This protocol will describe two conditions, the effects of which will be contrasted to
      determine the efficacy of ACT in treating anxiety and depressive symptoms among perinatal
      women. The ACT condition will be compared to a supportive psychoeducation intervention. The
      effects of the intervention will be determined in terms of self-report measures (anxiety and
      depressive symptoms, flexibility, mindfulness, social satisfaction) and diagnostic interviews
      (depression, anxiety). The impact of trauma history and psychodiagnostic history will be
      examined as moderating factors and/or covariates in the examination of the intervention's
      efficacy.

      This protocol will test the hypothesis that ACT is effective in reducing anxiety and
      depressive symptoms during the perinatal and postpartum periods. Second, the investigators
      will examine the intergenerational impact of the intervention on the offspring via offspring
      birth outcomes, as reported in the electronic medical record. Finally, the investigators will
      explore mediators and moderators of the treatment outcomes. This work will advance the
      understanding of the impact of brief interventions on perinatal well-being and improve the
      ability to disseminate empirically supported interventions for pregnant mothers.
    

Intervention name(s): Baseline Assessment (18-26 weeks pregnant); Online Intervention and Phone Coaching Interventions; Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum; Follow Up Assessments: 8 weeks postpartum
Intervention type(s): Diagnostic Test; Behavioral; Diagnostic Test; Diagnostic Test
Intervention description(s): At baseline, participants will complete several interviews and questionnaires online and via phone to determine psychological history, current functioning, history of trauma, coping styles, and demographic variables.; ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. The active comparator is the Supportive Control. Two phone coaching sessions will occur 2- and 4-weeks post-intervention in both conditions.; The follow-up assessments at 34-36 weeks pregnancy and 4-weeks postpartum will be completed via REDCap, an online secure survey platform in order to reduce participant burden.; The follow-up assessment at 8-weeks postpartum will be completed via phone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pregnancy; Mental Health