Online Mind/Body Program for Fertility

NCT03343405 | Completed

• 1 other identifier: MindBody
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Mind/Body

Outcome Measures

Primary Outcomes (3)

• Feasibility 1: Feasibility of recruitment and randomization

  Number of participants recruited and randomized. From time study began to when recruitment closed.

  Approximately 12 months

• Feasibility 2: Time

  Time between recruitment and completion of the study. Time between recruitment and randomization; time between each of the modules; time between each of the assessments (pre-assessment; mid-assessment; post-assessment, and follow-up).

  Approximately 12 months

• Feasibility 3: Participant retention and acceptability

  Percentage of enrolled participants that completed each stage of the study (mid-assessment, post-assessment, follow-up, and each of the ten modules for the intervention group only).

  Approximately 12 months

Secondary Outcomes (13)

• Acceptability 1: Ease of modules

  Approximately 12 months

• Acceptability 2: Helpfulness

  Approximately 12 months

• Satisfaction of Intervention

  Approximately 12 months

• Pregnancy: Between group comparison

  Approximately 12 months

• Anxiety 1: Individual changes

  Approximately 12 months

Other Outcomes (1)

• Satisfaction 2: Qualitative

  Approximately 12 Months

Study Arms (2)

Intervention: Online Mind/Body

EXPERIMENTAL

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.

Behavioral: Online Mind/Body Program for Fertility

Wait-List

NO INTERVENTION

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

Interventions

Online Mind/Body Program for Fertility BEHAVIORAL

The Mind/Body intervention involves (1) reducing physical symptoms of stress, (2) enhancing lifestyle behaviors related to fertility, (4) self-nurturing and coping skills, and (5) relaxation methods.

Intervention: Online Mind/Body

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (3)

• 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.

  PMID: 10731544 RESULT

• 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.

  PMID: 11129360 RESULT

• 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.

  PMID: 21496800 RESULT

MeSH Terms

Conditions

Infertility

Interventions

Fertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Jessica Clifton, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Associate

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: November 17, 2017
• Study Start: March 14, 2015
• Primary Completion: April 14, 2017
• Study Completion: April 14, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

US (1)