Clinical trial NCT03343405: Online Mind/Body Program for Fertility
Official title: Fertility & Well-Being: Mind/Body Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Mind/Body
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A between groups repeated measure experimental design. Participants that met inclusion criteria and were interested in continuing with the study were randomized to either the treatment or wait-list group. Participants randomized to the treatment group were provided with 10 online program modules provided weekly over 10 weeks. After 10-weeks the wait-list group had the opportunity to participate in the intervention protocol if they desire. All participants will be asked to complete pre-, mid-, post-, f/u- intervention questionnaires.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility 1: Feasibility of recruitment and randomization
timeFrame: Approximately 12 months
measure: Feasibility 2: Time
timeFrame: Approximately 12 months
measure: Feasibility 3: Participant retention and acceptability
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Acceptability 1: Ease of modules
timeFrame: Approximately 12 months
measure: Acceptability 2: Helpfulness
timeFrame: Approximately 12 months
measure: Satisfaction of Intervention
timeFrame: Approximately 12 months
measure: Pregnancy: Between group comparison
timeFrame: Approximately 12 months
measure: Anxiety 1: Individual changes
timeFrame: Approximately 12 months
measure: Anxiety 2: Between group changes
timeFrame: Approximately 12 months
measure: Depression 1: Individual changes
timeFrame: Approximately 12 months
measure: Depression 2: Between group changes
timeFrame: Approximately 12 months
measure: Stress: Between group changes
timeFrame: Approximately 12 months
measure: Mindfulness: Between group comparison
timeFrame: Approximately 12 months
measure: Fertility Problem Inventory: Between group changes
timeFrame: Approximately 12 months
measure: Emotion Regulation: Between group comparison
timeFrame: Approximately 12 months
measure: Relationship Quality: Between group comparison
timeFrame: Approximately 12 months
Other outcomes:
measure: Satisfaction 2: Qualitative
timeFrame: Approximately 12 Months
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Jessica Clifton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Domar AD, Clapp D, Slawsby EA, Dusek J, Kessel B, Freizinger M. Impact of group psychological interventions on pregnancy rates in infertile women. Fertil Steril. 2000 Apr;73(4):805-11. doi: 10.1016/s0015-0282(99)00493-8.
citation: Domar AD, Clapp D, Slawsby E, Kessel B, Orav J, Freizinger M. The impact of group psychological interventions on distress in infertile women. Health Psychol. 2000 Nov;19(6):568-75. doi: 10.1037//0278-6133.19.6.568.
citation: Domar AD, Rooney KL, Wiegand B, Orav EJ, Alper MM, Berger BM, Nikolovski J. Impact of a group mind/body intervention on pregnancy rates in IVF patients. Fertil Steril. 2011 Jun;95(7):2269-73. doi: 10.1016/j.fertnstert.2011.03.046. Epub 2011 Apr 15.