MiscarriagePhase 1/2NCT00194844
Couples Miscarriage Healing Project:Randomized Trial
A Phase 1/2 study testing Nurse Caring, Self Caring and Combined Caring in people with Miscarriage and Grief, run by University of Washington at 1 site in United States.
Trial summary
This is a randomized trial of three caring based interventions to see if we can help couples heal after miscarriage. All three are based on Swanson's theory of caring and Meaning of Miscarriage Model. The first, nurse caring, consists of three counseling sessions with a nurse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Miscarriage, Grief, Pregnancy Loss
- What is being tested?
- Nurse Caring, Self Caring and Combined Caring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jun 2006
- Phase
- Phase 1/2
- 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
- unexpected, unplanned loss of pregnancy prior to 20 weeks gestation
- no more than 12 weeks post loss
- both the woman who miscarried and her male mate agree to participate
- able to read, write, and speak in English
- If 18 or older in a self proclaimed committed heterosexual relationship
- If married, may be under 18
Who cannot join
- non heterosexual couples
- not geographically accessible to the Puget Sound area
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Nursing
Seattle, Washington, 98195
About this study
Official title: Caring Interventions for Couples Who Have Miscarried
This is a randomized trial of three caring based interventions to see if we can help couples heal after miscarriage. All three are based on Swanson's theory of caring and Meaning of Miscarriage Model. The first, nurse caring, consists of three counseling sessions with a nurse. The second intervention, self-caring, involves watching three videotapes and completing three workbooks. The third, combined caring, involves receiving one counseling session with a nurse followed up with the three videotapes and workbooks. There is also a control group that receives no intervention. All interventions are administered at 1, 6, and 11 weeks after study enrollment. Couples can enroll who are no more than 12 weeks post miscarriage of a pregnancy that ended at 20 weeks gestation or less. At 1, 6, 16, and 52 weeks post enrollment we ask couples to complete mailed booklets that contain a variety of research questionnaires about their emotional health, integration of loss, and couple relationship.
Read the detailed description
The purpose of this randomized study is to compare the effects of nurse caring (3 nurse counseling sessions), self-caring (3 home-delivered videotapes and journals), combined caring (1 nurse counseling plus 3 videotapes and journals) and no intervention (control) on the emotional healing, integration of loss, and couple well-being of women and their partners (husbands or male mates) in the first year after miscarrying. A recent IoM [41] report claims one of the greatest obstacles to determining effectiveness of home-based interventions is getting clients to complete treatment protocols, thus the combined-caring group is included to determine if nurse endorsement of the videotape/journal modules enhances adherence and increases the efficacy of the self-caring protocol. All intervention materials are based on Swanson's middle-range caring theory [109,112] and Meaning of Miscarriage Model [116]. Both frameworks were phenomenologically derived and subsequently applied and tested in the Miscarriage Caring Project (MCP), a randomized trial of the effects of 3 caring-based nurse counseling sessions on women's emotional well-being and integration of loss in the first year after miscarriage [115]. The MCP is the only randomized post-miscarriage intervention that has led to significant positive mental health outcomes for women.
There are no published studies of interventions that have led to significant outcomes for men or couples post miscarriage. Yet, the PI's experience counseling couples groups (also based on the caring theory and miscarriage model) has provided consistent, albeit anecdotal, evidence that including partners helps couples to reach out to each other, integrate miscarriage into their lives, and resolve grieving. Therefore, this project focuses on women and their partners (spouses or male mates in a committed relationship). An additional goal is to determine if an innovative, easily delivered, low-cost video/journal intervention is as effective as interpersonal counseling in assisting women and their partners to emotionally heal, integrate loss, and experience couple well being in the first year after miscarriage.
The procedural aims are to:
- Develop an empirically derived self-caring intervention for couples who have miscarried. This home-delivered intervention will be a series of three modules consisting of broadcast quality videotapes ("Miscarriage: Caring and Healing") and journal assignments. (drafts are in Appendices B.1 to B.3.)
- Train nurses to deliver a three session caring-based counseling intervention to couples.
- Randomly assign couples who recently miscarried to one of four groups: group I (nurse caring) will receive three counseling sessions. Couples in group II (combined-caring) will receive one counseling session plus three self-caring videotape / journal modules; Group III (self-caring) will receive the three self-caring videotape / journal modules. Group IV (control) will receive no intervention.
There are four hypothesis-testing specific aims and one exploratory research aim:
- Compared to controls, women and their partners who receive nurse, combined, or self-caring will report significantly more emotional healing, stronger integration of loss, and greater couple well-being in the first year subsequent to miscarriage.
- Comparing the three modes of delivering caring (nurse, combined, and self), for women and their partners, there will be no differences in emotional healing, integration of loss, and couple well-being
- Comparing self-caring to combined-caring, for women and their partners, within and across intervention times, there will be no differences in intervention adherence and / or evaluation scores.
- Comparing the nurse-caring group to the combined-caring group, for women and their partners, there will be no differences in ratings of counselor empathy and caring at the first counseling session.
- Determine associations amongst background variables, intervention monitoring scores, intervening variables, emotional healing, integration of loss, and couple well-being for women and their partners at 1 week, 6 weeks, 4 months and 1 year post-enrollment.
- Conditions
- Miscarriage, Grief, Pregnancy Loss
- Being tested
- Nurse Caring, Self Caring, Combined Caring
- Keywords
- caring, miscarriage, grief, couples, counseling
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse CaringBehavioural
Nurse Caring: Couples receive three one hour counseling session with a nurse interventionist at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
Self CaringBehavioural
Self Caring: Couples receive a mailed videotape and workbook at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
Combined CaringBehavioural
Combined Caring: Couples receive one counseling session from a nurse interventionist at approximately one week after enrollment. Upon completion of the session the nurse will hand the couple a self-caring videotape and workbook. Couples will be mailed an additional videotape and workbook at approximately 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nurse Caring Receives: Behavioral: Nurse Caring |
| 2 | Experimental | Self Caring Receives: Behavioral: Self Caring |
| 3 | Experimental | Combined Caring Receives: Behavioral: Combined Caring |
| 4 | No intervention | This group is not treated and serves as control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nikcevic Miscarriage Grief Inventory
Measured: first year after miscarriage
Secondary outcomes (2)
Depression(CES-D); Mood Disturbances(POMS); Coping (Modified Folkman and Lazarus Ways of Coping); Emotional Strength (Swanson); Impact of Miscarriage (Swanson)
Measured: first year after miscarriage
Couple relationship Mate Caring (Swanson); Support of Mate and Others (Brown); Intimacy (PAIR); Professional Caring (Swanson)
Measured: first year after miscarriage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2001
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Kristen M Swanson, RN, PhD, Principal investigator, University of Washington School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194844
- Sponsor's protocol ID
- 01-1206-G 02
- Other IDs
- 5R01NR005343-04
- Status last verified
- Feb 2008
- First submitted
- 13 Sep 2005
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring Interventions for Couples Who Have Miscarried
- ClinicalTrials.gov ID
- NCT00194844
- Acronym / sponsor ID
- 01-1206-G 02
- Conditions
- Miscarriage, Grief, Pregnancy Loss
- Keywords
- caring, miscarriage, grief, couples, counseling
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- 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 is a randomized trial of three caring based interventions to see if we can help couples heal after miscarriage. All three are based on Swanson's theory of caring and Meaning of Miscarriage Model. The first, nurse caring, consists of three counseling sessions with a nurse. The second intervention, self-caring, involves watching three videotapes and completing three workbooks. The third, combined caring, involves receiving one counseling session with a nurse followed up with the three videotapes and workbooks. There is also a control group that receives no intervention. All interventions are administered at 1, 6, and 11 weeks after study enrollment. Couples can enroll who are no more than 12 weeks post miscarriage of a pregnancy that ended at 20 weeks gestation or less. At 1, 6, 16, and 52 weeks post enrollment we ask couples to complete mailed booklets that contain a variety of research questionnaires about their emotional health, integration of loss, and couple relationship.
Detailed description
The purpose of this randomized study is to compare the effects of nurse caring (3 nurse counseling sessions), self-caring (3 home-delivered videotapes and journals), combined caring (1 nurse counseling plus 3 videotapes and journals) and no intervention (control) on the emotional healing, integration of loss, and couple well-being of women and their partners (husbands or male mates) in the first year after miscarrying. A recent IoM [41] report claims one of the greatest obstacles to determining effectiveness of home-based interventions is getting clients to complete treatment protocols, thus the combined-caring group is included to determine if nurse endorsement of the videotape/journal modules enhances adherence and increases the efficacy of the self-caring protocol. All intervention materials are based on Swanson's middle-range caring theory [109,112] and Meaning of Miscarriage Model [116]. Both frameworks were phenomenologically derived and subsequently applied and tested in the Miscarriage Caring Project (MCP), a randomized trial of the effects of 3 caring-based nurse counseling sessions on women's emotional well-being and integration of loss in the first year after miscarriage [115]. The MCP is the only randomized post-miscarriage intervention that has led to significant positive mental health outcomes for women.
There are no published studies of interventions that have led to significant outcomes for men or couples post miscarriage. Yet, the PI's experience counseling couples groups (also based on the caring theory and miscarriage model) has provided consistent, albeit anecdotal, evidence that including partners helps couples to reach out to each other, integrate miscarriage into their lives, and resolve grieving. Therefore, this project focuses on women and their partners (spouses or male mates in a committed relationship). An additional goal is to determine if an innovative, easily delivered, low-cost video/journal intervention is as effective as interpersonal counseling in assisting women and their partners to emotionally heal, integrate loss, and experience couple well being in the first year after miscarriage.
The procedural aims are to:
- Develop an empirically derived self-caring intervention for couples who have miscarried. This home-delivered intervention will be a series of three modules consisting of broadcast quality videotapes ("Miscarriage: Caring and Healing") and journal assignments. (drafts are in Appendices B.1 to B.3.)
- Train nurses to deliver a three session caring-based counseling intervention to couples.
- Randomly assign couples who recently miscarried to one of four groups: group I (nurse caring) will receive three counseling sessions. Couples in group II (combined-caring) will receive one counseling session plus three self-caring videotape / journal modules; Group III (self-caring) will receive the three self-caring videotape / journal modules. Group IV (control) will receive no intervention.
There are four hypothesis-testing specific aims and one exploratory research aim:
- Compared to controls, women and their partners who receive nurse, combined, or self-caring will report significantly more emotional healing, stronger integration of loss, and greater couple well-being in the first year subsequent to miscarriage.
- Comparing the three modes of delivering caring (nurse, combined, and self), for women and their partners, there will be no differences in emotional healing, integration of loss, and couple well-being
- Comparing self-caring to combined-caring, for women and their partners, within and across intervention times, there will be no differences in intervention adherence and / or evaluation scores.
- Comparing the nurse-caring group to the combined-caring group, for women and their partners, there will be no differences in ratings of counselor empathy and caring at the first counseling session.
- Determine associations amongst background variables, intervention monitoring scores, intervening variables, emotional healing, integration of loss, and couple well-being for women and their partners at 1 week, 6 weeks, 4 months and 1 year post-enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Nurse CaringNurse Caring |
| 2 | Experimental | Behavioral: Self CaringSelf Caring |
| 3 | Experimental | Behavioral: Combined CaringCombined Caring |
| 4 | No intervention | –This group is not treated and serves as control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- unexpected, unplanned loss of pregnancy prior to 20 weeks gestation
- no more than 12 weeks post loss
- both the woman who miscarried and her male mate agree to participate
- able to read, write, and speak in English
- If 18 or older in a self proclaimed committed heterosexual relationship
Key exclusion criteria (2 listed)
- non heterosexual couples
- not geographically accessible to the Puget Sound area
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 |
|---|---|---|
| Nurse CaringNurse Caring: Couples receive three one hour counseling session with a nurse interventionist at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring. | Behavioural | 1 |
| Self CaringSelf Caring: Couples receive a mailed videotape and workbook at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring. | Behavioural | 2 |
| Combined CaringCombined Caring: Couples receive one counseling session from a nurse interventionist at approximately one week after enrollment. Upon completion of the session the nurse will hand the couple a self-caring videotape and workbook. Couples will be mailed an additional videotape and workbook at approximately 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring. | Behavioural | 3 |
Primary outcome
Nikcevic Miscarriage Grief Inventory
Time frame: first year after miscarriage
2 secondary outcomes
Depression(CES-D); Mood Disturbances(POMS); Coping (Modified Folkman and Lazarus Ways of Coping); Emotional Strength (Swanson); Impact of Miscarriage (Swanson)
Time frame: first year after miscarriage
Couple relationship Mate Caring (Swanson); Support of Mate and Others (Brown); Intimacy (PAIR); Professional Caring (Swanson)
Time frame: first year after miscarriage
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 18 Feb 2008.
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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.
Kristen M Swanson, RN, PhD principal investigator
University of Washington School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nurse Caring, Self Caring and Combined Caring in people with Miscarriage and Grief, run by University of Washington 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 6 inclusion and 2 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 18 Feb 2008. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nikcevic Miscarriage Grief Inventory (time frame: first year after miscarriage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2008.