Factors Predicting Ineffective Contraception Use

NCT ID: NCT03500978

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-19
• Study Completion Date: 2019-05-31

Brief 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.

Conditions

Contraception Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Peer CBT Intervention

Women allocated to the peer-specialist delivered CBT intervention group will be mailed an intervention workbook (CBT exercises) 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.

Group Type: EXPERIMENTAL

Peer CBT Intervention

Intervention Type: BEHAVIORAL

Peer specialist delivery of cognitive behavioral therapy intervention over the phone.

Control

Women allocated to the observation-only control group will not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peer CBT Intervention

Peer specialist delivery of cognitive behavioral therapy intervention over the phone.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• female, aged 18-45, sexually active with a man in past 3 months, report inconsistent or no contraception use in the past 3 months, English speaking, own a smartphone, report subclinical to mild depressive symptoms in past two weeks (score 5 to 14 on PHQ-9)

Exclusion Criteria

• pregnant, using Long Acting Reversible Contraceptives, sterilized, planning to get pregnant in the next 6 months, report acute suicide risk (assessed via the PHQ Follow-up Suicide Risk Assessment form or self-repot a suicide attempt in the past 6 months)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Lepore, PHD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University School of Medicine OB/GYN

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

1R21HD091927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HD091927

Identifier Type: -

Identifier Source: org_study_id