InfertilityNCT03343405
Online Mind/Body Program for Fertility
A study testing Online Mind/Body Program for Fertility in people with Infertility, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Online Mind/Body Program for Fertility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2015to 14 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women and Men
- Infertility diagnosis
- Trying to get pregnant
- 18 years or older
- Read and write English
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Fertility & Well-Being: Mind/Body Protocol
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Online Mind/Body Program for Fertility
- Keywords
- Mind/Body
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mind/Body Program for FertilityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility 1: Feasibility of recruitment and randomization
Number of participants recruited and randomized. From time study began to when recruitment closed.
Measured: 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).
Measured: 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).
Measured: Approximately 12 months
Secondary outcomes (13)
Acceptability 1: Ease of modules
Participants will be asked at the end of each module: "how easy was this module." Answer choices are on a 3-point Likert scale, ranging from 1 ("easy") to 3 ("not easy"). Data collected from beginning to end of intervention.
Measured: Approximately 12 months
Acceptability 2: Helpfulness
Participants will be asked at the end of each module: "how helpful was the module." Answer choices are on a four-item Likert scale ranging from 0 ("unhelpful") to 3 ("very helpful"). Data is collected throughout the Mind/Body program, intervention group only.
Measured: Approximately 12 months
Satisfaction of Intervention
Participant satisfaction as measured by the Client Satisfaction Inventory Short-Form (McMurtry \& Hudson, 2000). This measurement is a 9-item self-report scale that assesses the satisfaction of the participant with the effects of the treatments. Participants are asked to rate the way they feel about the services they received on a 7-point Likert scale, ranging from 1 ("none of the time") to 7 ("all of the time"). The total scores range between 0 and 100 (for scoring algorithm, see McMurty \& Hudson, 2000), with higher scores indicating more satisfaction. Data is collected for the intervention group at post-assessment only.
Measured: Approximately 12 months
Pregnancy: Between group comparison
Self-reported confirmation of pregnancy. Data collected at baseline, pre-assessment, mid-assessment, post-assessment, and follow-up.
Measured: Approximately 12 months
Anxiety 1: Individual changes
Individual changes in anxiety as measured by the Beck Anxiety Inventory. The Beck Anxiety Inventory is a 21-item self-report measure used to assess somatic or panic-related anxiety symptoms. Individuals are asked to rate their symptoms of anxiety over the past week on a 4-point Likert scale from 0 ("not at all") to 3 ("severely; I could barely stand it"). A total score is calculated by summing all items. Scores range from 0 (no anxiety severity) to 63 (severe anxiety severity). Data collected throughout study (baseline, pre-assessment, mid-assessment, post-assessment, and follow-up) as well as at the beginning of each intervention module.
Measured: Approximately 12 months
Anxiety 2: Between group changes
Between group changes in anxiety as measured by Beck Anxiety Inventory (Beck, Steer, Beck, \& Newman, 1993). The Beck Anxiety Inventory is a 21-item self-report measure used to assess somatic or panic-related anxiety symptoms. Individuals are asked to rate their symptoms of anxiety over the past week on a 4-point Likert scale from 0 ("not at all") to 3 ("severely; I could barely stand it"). A total score is calculated by summing all items. Scores range from 0 (no anxiety severity) to 63 (severe anxiety severity). Data collected throughout study (baseline, pre-assessment, mid-assessment, post-assessment, and follow-up) as well as at the beginning of each intervention module.
Measured: Approximately 12 months
Depression 1: Individual changes
Individual changes in depression as measured by the Beck Depression Inventory - 2nd Edition. The Beck Depression Inventory - 2nd Edition is a 21-item self-report measure used to assess cognitive, affective, and physical depressive symptoms. Questions include content such as sadness, guilt, disappointment, and loss of energy. Participants are asked to rate each item on a 4-point Likert scale from 0 (not endorsed) to 3 (endorsed at maximum severity). A total score is calculated by summing all items. Scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Data collected at baseline, pre-assessment, mid-assessment, post-assessment and follow-up).
Measured: Approximately 12 months
Depression 2: Between group changes
Between group changes in depression as measured by the Beck Depression Inventory - 2nd Edition (Beck, Steer, Ball, \& Ranieri, 1996). The Beck Depression Inventory - 2nd Edition is a 21-item self-report measure used to assess cognitive, affective, and physical depressive symptoms. Questions include content such as sadness, guilt, disappointment, and loss of energy. Participants are asked to rate each item on a 4-point Likert scale from 0 (not endorsed) to 3 (endorsed at maximum severity). A total score is calculated by summing all items. Scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Data collected at baseline, pre-assessment, mid-assessment, post-assessment and follow-up).
Measured: Approximately 12 months
Stress: Between group changes
Between group changes in stress as measured by Perceived Stress Scale. The Perceived Stress Scale is a 10-item questionnaire measuring the present level of self-rated stress in the last month. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Higher scores indicate more distress. Participants are asked to rate each item on a 5-point Likert scale from 0 ("never") to 4 ("very often"). Scores range from 0 to 40 where higher scores indicate greater perceived stress (for scoring algorithm see Cohen, 1988; Cohen, Kamarck, \& Mermelstein, 1983).
Measured: Approximately 12 months
Mindfulness: Between group comparison
Between group changes in mindfulness as measured by the Five-Factor Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer, \& Toney, 2006). The FFMQ is a 39-item self-report measure used to assess a trait-like tendency to be mindful in daily life. It has five subscales (i.e., observe, describe, awareness, non-judgmental, and non-reactive). Each question on the FFMQ is rated on a 5-point Likert scale ranging from 1 ("never or very rarely true") to 5 ("very often or always true"). Total score (adding subscale scores) ranges from 39 to 195 with higher scores indicating greater mindfulness (for scoring algorithm see Baer, Smith, Hopkins, Krietemeyer, \& Toney, 2006). Data collected at baseline, mid-assessment, and post-assessment.
Measured: Approximately 12 months
Fertility Problem Inventory: Between group changes
Between group changes in fertility related distress as measured by The Fertility Problem Inventory. The Fertility Problem Inventory is a 46-item questionnaire that measures domains (Social Concern, Sexual Concern, Relationship Concern, Need for Parenthood, and Rejection of Child-Free Lifestyle) considered important in understanding perceived infertility related stress as well as an overall global index of infertility-related stress (composite score of the all domains). The overall score ranges from 46 to 276. For each of the scales, higher scores indicate more fertility related distress (for a scoring algorithm see Newton, Sherrard, \& Glavac, 1999). Data collected at baseline, post-assessment, and follow-up.
Measured: Approximately 12 months
Emotion Regulation: Between group comparison
Between group changes in emotion regulation as measured by the Difficulties in Emotional Regulation Scale (DERS; Gratz \& Roemer, 2004). The DERS is a 36-item self-report questionnaire measuring problems with emotional regulation based on responses indicating impairment in six dimensions (Goals, Impulse, Awareness, Nonacceptance, Strategy, and Clarity) and a total score (sum of all subscales). Total score ranges from 36 to 180. For each of the scales, higher scores indicate greater difficulties with emotional regulation in each of the domains (for scoring algorithm see Gratz \& Roemer, 2004). Data collected at baseline and post-assessment.
Measured: Approximately 12 months
Relationship Quality: Between group comparison
Between group changes in emotion regulation as measured by the Dyadic Adjustment Scale (Spanier, 1976). The Dyadic Adjustment Scale is a 32-item questionnaire assessing relationship difficulty in four domains (Consensus, Satisfaction, Affective Expression, and Cohesion) and a total score. The total score ranges form 0 and 151. Greater scores indicate greater marital satisfaction (for scoring algorithm see, Spanier, 1976). Data collected at baseline and post-assessment.
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start14 Mar 2015
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Clifton, University of Vermont
- Investigators
- Jessica Clifton, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343405
- Sponsor's protocol ID
- MindBody
- Status last verified
- Nov 2017
- First submitted
- 19 Sep 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10731544Domar 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.
PubMed 11129360Domar 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.
PubMed 21496800
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility & Well-Being: Mind/Body Protocol
- ClinicalTrials.gov ID
- NCT03343405
- Acronym / sponsor ID
- MindBody
- Conditions
- Infertility
- Keywords
- Mind/Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 14 Mar 2015 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Online Mind/Body | Experimental | Behavioral: Online Mind/Body Program for FertilityParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women and Men
- Infertility diagnosis
- Trying to get pregnant
- 18 years or older
- Read and write English
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Mind/Body Program for FertilityThe 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. | Behavioural | Intervention: Online Mind/Body |
Primary outcome
Feasibility 1: Feasibility of recruitment and randomization
Time frame: Approximately 12 months
Number of participants recruited and randomized. From time study began to when recruitment closed.
Feasibility 2: Time
Time frame: Approximately 12 months
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).
Feasibility 3: Participant retention and acceptability
Time frame: Approximately 12 months
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).
13 secondary outcomes
Acceptability 1: Ease of modules
Time frame: Approximately 12 months
Acceptability 2: Helpfulness
Time frame: Approximately 12 months
Satisfaction of Intervention
Time frame: Approximately 12 months
Pregnancy: Between group comparison
Time frame: Approximately 12 months
Anxiety 1: Individual changes
Time frame: Approximately 12 months
Anxiety 2: Between group changes
Time frame: Approximately 12 months
Depression 1: Individual changes
Time frame: Approximately 12 months
Depression 2: Between group changes
Time frame: Approximately 12 months
Stress: Between group changes
Time frame: Approximately 12 months
Mindfulness: Between group comparison
Time frame: Approximately 12 months
Fertility Problem Inventory: Between group changes
Time frame: Approximately 12 months
Emotion Regulation: Between group comparison
Time frame: Approximately 12 months
Relationship Quality: Between group comparison
Time frame: Approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Results publication: PubMed 10731544Domar 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.
- Results publication: PubMed 11129360Domar 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.
- Results publication: PubMed 21496800Domar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Clifton, Ph.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mind/Body Program for Fertility in people with Infertility, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility 1: Feasibility of recruitment and randomization (time frame: Approximately 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03343405, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.