Factors Predicting Ineffective Contraception Use
Condition: Contraception Behavior
Study type: Interventional

Summary: 
      Unintended pregnancy (UP), defined as a mistimed or unwanted pregnancy, is a significant and
      prevalent public health problem, particularly among low-income women. Over half of all
      pregnancies are reportedly unintended and UP has been linked to adverse health outcomes in
      mothers and their children. Correct and consistent use of effective contraception is the
      primary method to prevent UP. Research has shown that low self-esteem and elevated depressive
      symptoms increase women's risk for ineffective contraception use and, by extension, for UP.
      This project examines the feasibility and possible efficacy of reducing ineffective
      contraception using an intervention that addresses depressive symptoms and self concept among
      young, low-income, predominantly minority women at risk for UP. Traditional cognitive
      behavioral therapy (CBT) is effective in reducing depressive symptoms and improving self
      concept; but limited utilization, poor response, and low adherence to CBT is common among
      low-income and minority women. A more acceptable method for delivering CBT is needed for the
      target population. This project will use peer-specialists to deliver a CBT-based intervention
      to women at risk for UP. Because peer specialists are drawn from the same community as the
      target population and share some similar life experiences, the intervention may be more
      acceptable and effective than one offered by trained professionals.

      This project will examine the effectiveness of a 9 week (8-session) peer-specialist led
      CBT-based intervention compared to an observational control condition to reduce depressive
      symptoms, improve self-esteem, and improve consistent contraceptive use to prevent UP. The
      weekly intervention sessions are delivered by telephone by a trained peer specialist. The
      study will evaluate the effectiveness of the intervention to improve consistent contraceptive
      use (primary outcome) and decrease depressive symptoms and increase self-esteem (secondary
      outcomes).
    

Detailed description: 
      This is a randomized controlled trial with one intervention group (peer-specialist led
      telephone-based CBT) and an observation only control group. There will be 3 measurement
      periods: baseline (pre-intervention), 10-week follow-up (post-intervention) and 14-week
      follow up. The 14-week follow up assesses the primary outcome (consistency of contraception
      use) and secondary outcomes (psychological symptoms and self-esteem), whereas the 10-week
      follow up assesses mediating variables (sexual self-efficacy, contraceptive self-efficacy,
      social support and coping). There is also a 4-week, mid-intervention assessment of outcomes
      designed to assess if there is a worsening of symptoms that needs to be addressed (e.g.
      referral for spike in depression or emergence of suicidal intent). This midterm evaluation
      also allows us to monitor the well-being of the control group, which has significantly less
      contact with project staff than the intervention group.

      We will recruit 132 sexually active women from health care clinics (e.g., family planning,
      OB/GYN), with the aim of retaining at least 92 (46 per condition). Interested women will be
      consented and screened for eligibility in a private area of the clinics. They will be
      contacted by phone after consent to complete a structured, baseline questionnaire. After the
      baseline questionnaire, women will be randomly allocated to study conditions. Women will be
      randomized based on the randomization schedule established by the project biostatistician.
      Women allocated to the CBT intervention group will be mailed an intervention workbook and
      have their first telephone-based intervention session scheduled. The CBT intervention group
      will receive 8 telephone-based CBT intervention sessions (over 9 weeks) delivered by peer
      specialists. Each session will last up to 30 minutes. The control group will be an
      observation only control group (CTL group). They will not receive any intervention. The
      post-intervention and 1-month follow up questionnaires will also be collected via structured
      telephone interviews. Research staff who are collecting data will be blinded to study
      condition.

      In addition to monitoring for worsening of psychological symptoms, procedures are in place
      for referring participants with worrisome increases in depression (i.e., >14 on the PHQ9) or
      suicidal intent to relevant mental health resources, including hospital emergency rooms and
      suicide hotlines for persons expressing suicidal intent. Further, the DSMB will be alerted so
      that they can monitor whether one condition appears to have an unusually high increase in
      symptoms, which might warrant stopping the trial for safety reasons. In addition, the
      researchers collecting data and the peer-specialists implementing the intervention will be
      engaged in weekly supervision with a clinical psychologist and have access to the study PI at
      all times. The project biostatistician will conduct all intention-to-treat (ITT) analyses
      using appropriate modern statistical approaches.
    

Intervention name(s): Peer CBT Intervention
Intervention type(s): Behavioral
Intervention description(s): Peer specialist delivery of cognitive behavioral therapy intervention over the phone.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group (behavioral intervention vs. no treatment) randomized trial with a pre-intervention and 10- and 14-week post-intervention assessment phases.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention