Online Mind/Body Program for Fertility

University of Vermont

Status: Completed

Conditions: Infertility

Treatments: Behavioral: Online Mind/Body Program for Fertility

Study type: Interventional

Funder types: Other

Identifiers

NCT03343405

MindBody

Details and patient eligibility

About

This pilot-study assesses the feasibility and acceptability of an Online Mind/Body Fertility Program, designed to help individuals and/or couples cope with the physical and emotional impact of infertility by learning special relaxation strategies and improving lifestyle habits. Participants included women experiencing infertility who had not given birth to a child. Half of participants received access to the 10-week Online Mind-Body Program and the other half were placed on a waiting-list.

Full description

Infertility is defined as the inability to conceive a child. A couple may be acknowledged as infertile if conception has not occurred after 12 months of having regular, unprotected intercourse. Over six million couples in the United States are affected by infertility. Research suggests that there is a relationship between psychological distress and infertility, but the relationship is complex. The information from this study will be used to better understand the relationship between psychological distress and infertility among couples. Furthermore, the investigators are interested in testing Dr. Alice Domar's Mind/Body Fertility Program that was designed to help individuals regain control of their life and learn new lifestyle habits that can increase their chances of conceiving. There is evidence that individuals that participated in the group format of this treatment protocol showed statistically significant decreases in physical and psychological symptoms of stress and increases in conception rates. Our primary goals are to evaluate patients willingness to be recruited and randomized as well as their adherence and attrition to the program. Our secondary goals are to evaluate reductions in emotional distress (i.e., anxiety, depression, and stress) and enhance emotion regulation skills as well as pregnancy rates.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women and Men
• Infertility diagnosis
• Trying to get pregnant
• 18 years or older
• Read and write English

Exclusion criteria

• No current diagnosis for an active psychotic disorder, eating disorder, substance abuse or dependence
• Not reporting current suicidal ideation/intent
• No psychotropic medication changes in the last four weeks
• Has not completed a formal mind/body program focused on infertility that included relaxation, yoga, mindfulness, cognitive restructuring, stress reduction strategies, listening and communication skills, goal setting and assertiveness training.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Intervention: Online Mind/Body

Experimental group

Description:

Participants randomized to the intervention group (i.e., Online Mind/Body Program for Fertility) were provided the 10 online modules provided weekly (one module per week), intended to be completed over 10 weeks. Additionally, participants received weekly therapeutic feedback.

Treatment:

Behavioral: Online Mind/Body Program for Fertility

Wait-List

No Intervention group

Description:

After 10-weeks being in the wait-list group, participants had the potential to participate in the intervention protocol if they desire.