Factors Predicting Ineffective Contraception Use

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).

Study Overview

• Status: Completed
• Conditions: Contraception Behavior
• Intervention / Treatment: Behavioral: Peer CBT Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University School of Medicine OB/GYN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Peer CBT Intervention; Peer specialist delivery of cognitive behavioral therapy intervention over the phone.
NO_INTERVENTION: Control; Women allocated to the observation-only control group will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consistent contraception use at 14-week follow-up	Categorical (yes/no). Self report of using birth control consistently in prior month with a male sexual partner.	14-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean level of depressive symptoms from baseline to 14-week follow-up	9-item PHQ-9 Depressive Symptoms Scale. Self-report measure of depressive symptoms over the past two weeks. Each item is scored 0 (not at all) to 3 (nearly every day). Higher scores indicated greater depressive symptoms. The maximum score is 27. Symptom scores can be categorized by levels: 5-9 = minimal; 10-14 = mild; 15-19 moderately severed; 20+ = severe.	at 14-week follow-up
Change in mean level of self esteem from baseline to 14-week follow-up	20-item State Self Esteem Scale. Self-report measure of state (current) self esteem, includes 3 subscales (performance, appearance, and social). Each item is scored 1 (not at all) to 5 (extremely). Items are coded such that higher scores indicated higher self esteem. A mean scale score is calculated, ranging from 1 to 5.	at 14-week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean level of anxiety symptoms from baseline to 14-week follow-up	Exploratory secondary outcome measured with the 7-item Generalized Anxiety Disorder (GAD-7) scale. Each item is scored from 0 (not at all) to 3 (nearly every day). Items are summed with possible scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms.	14-week follow-up
Change in mean level of somatic symptoms from baseline to 14-week follow-up	Exploratory secondary outcome measured with the 15-item Patient Health Questionnaire Somatic Symptom Scale (PHQ-15). Each item is scored from 0 (not bothered) to 2 (bothered a lot). Items are summed with possible scores ranging from 0 to 30. Higher scores indicate more severe somatic symptoms.	14-week follow-up
Change in mean level of perceived social support (belonging) from baseline to 10-week follow-up	Secondary outcome (mediator) measured with the 5-item General Mattering Scale. Items are scored from 0 (Not at all) to 4 (Very much). Items are summed with scores ranging from 0 to 20. Higher scores indicate a greater sense of mattering to others (belonging).	10-week follow-up
Change in mean level of sexual self-efficacy from baseline to 10-week follow-up	Secondary outcome (mediator) measured with 8 items representing the "Say No" subscale of Rosenthal's Sexual Self-Efficacy Scale. Each item is scored from 1 (Not at all sure) to 4 (Very sure). The mean level of self-efficacy is calculated with a range of 1 to 4.	10-week follow-up
Change in mean level of contraceptive self-efficacy from baseline to 10-week follow-up	Secondary outcome (mediator) measuring contraceptive self-efficacy. 5 items adapted from Lauby's self-efficacy measure for condom use. Items are scored from 1 (Not at all sure) to 4 (Very sure). Scores range from 5 to 20 and a higher score indicates greater perceived self-efficacy.	10-week follow-up
Change in mean level of coping from baseline to 10-week follow-up	Secondary outcome (mediator) measured with two subscales (8 items) of the COPE measure: planning (4 items) and positive reinterpretation and growth (4 items). Items are scored from 1 (Not at all) to 5 (Very much). Items for each subscale are summed with a possible score ranging from 4 to 20 for each subscale. Higher scores indicate more active coping efforts.	10-week follow-up

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2018
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): May 31, 2019

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HD091927; 1R21HD091927 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no institutional resources (i.e., administrative and technical support) available at the end of the trial to support data sharing (e.g., review and respond to requests, store data and associated protocols, and deliver data and respond to queries about the data).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No