StressNCT05026372
Two-Session Couples Class to Improve Relationship Health
A study testing Mindfulness Compassion (MC), Mindfulness Gratitude (MG) and Mindfulness Value-Based Living (MV) in people with Stress, run by Sam Houston State University at 1 site in United States.
Trial summary
This study will compare the effect of three different stress reduction intervention techniques compared to a non-intervention control group on the psychological and relationship functioning in 40 romantic couples. The current study will serve two purposes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Mindfulness Compassion (MC), Mindfulness Gratitude (MG) and Mindfulness Value-Based Living (MV)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 31 May 2023
- 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
- ADULT ROMANTIC COUPLES in a relationship for a minimum of 6 months COHABITATING for a minimum of 6 months STRESS. At least one member of the romantic dyad reports stress above the normative mean for young adults (i.e., Perceived Stress Scale score > 17; Cohen \& Janicki-Deverts, 2012).
Who cannot join
- INDIVIDUALS UNDER AGE 18: This study only involves adult participants. NON-ENGLISH SPEAKING INDIVIDUALS: This study only involves participants who can speak English.
- ATTENDING PSYCHOTHERAPY: This stud only involves individuals who are not currently (self-defined) participating in psychotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sam Houston State University
Huntsville, Texas, 77340
About this study
This study will compare the effect of three different stress reduction intervention techniques compared to a non-intervention control group on the psychological and relationship functioning in 40 romantic couples. The current study will serve two purposes. Results will inform future efforts to develop effective brief stress reduction interventions for physically healthy couples and will inform future iterations of stress reduction-based intervention for cancer patients and their caregivers.
The investigators hypothesize that couples in the three stress-reduction interventions will report greater relationship health and greater mindfulness after the intervention than couples in the non-intervention control group. The investigators also hypothesize that the stress-reduction groups will be most beneficial for individuals who report higher distress, indifferent relationship style, and insecure attachment at baseline.
Read the detailed description
Participants will be randomly assigned to one of four conditions, each of which involve participating in two 45-minute sessions (via Zoom) with a study interventionist. Sam Houston State University (SHSU) clinical psychology master's or doctoral students or graduates of the SHSU clinical psychology master's program will implement the mind-body intervention, under the supervision of Dr. Chelsea Ratcliff, who is a licensed psychologist. Dr. Ratcliff will provide weekly group supervision to all students implementing the treatment.
Participation in this study will last a total of 6 weeks (+/- 1 week). The T1 survey will last approximately 45 minutes. Within 1 week of both partners completing baseline, eligible dyads will be scheduled for Session 1. For the intervention, all participants will be emailed a PDF of the appropriate workbook prior to Session 1. Participants will also be informed that they may pick up a hard copy (printed version).
For participants in the stress-reduction groups, after each session the interventionist will send each participant an email with: 1) the audio recording of the appropriate guided stress-reduction activity (transcript provided in workbook), 2) a fillable PDF document with instructions regarding completing and documenting home-practice, and 3) a link to a Qualtrics survey that asks them to evaluate their experience in the session. The instructor will also inform participants that they may pick up hard copies of all session materials if it is convenient/preferable. For participants in the non-intervention control group, the interventionist will email each participant a link to a Qualtrics survey that asks them to evaluate their experience in the session.
Session 2 will take place approximately 1 week after Session 1. After completing session 2, the interventionist will send a link to another Qualtrics survey that asks them to evaluate their experience in the session.
Within 1 week of completing Session 2, both members of the dyad will be emailed the link to the second Qualtrics survey (T2), which will last approximately 30 minutes. Finally, within 1 month (+/- 1 week) of completing Session 2, both members of the dyad will be emailed the third Qualtrics survey (T3), which will last approximately 20 minutes.
- Conditions
- Stress
- Being tested
- Mindfulness Compassion (MC), Mindfulness Gratitude (MG), Mindfulness Value-Based Living (MV)
- Keywords
- couples stress, health, psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Compassion (MC)Behavioural
The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
Mindfulness Gratitude (MG)Behavioural
The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
Mindfulness Value-Based Living (MV)Behavioural
The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness + Compassion (MC) | Experimental | For participants randomized to the MC condition will focus on compassion and creating positive emotions. This session will include techniques such as guided visualizations and a loving kindness meditation that are intended to facilitate connection with their partners. During this session, couples will also learn the ground rules of mindful and compassionate listening and sharing, as they will be asked to engage in an emotional disclosure task. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. Receives: Behavioral: Mindfulness Compassion (MC) |
| Mindfulness + Gratitude (MG) | Experimental | Session 2 for participants randomized to group MG will focus on gratitude. Participants will be taught to reflect on things, events, and people which they are grateful for via a gratitude meditation. Couples will share their experiences of practicing gratitude. The instructor will remind the couple of ground rules prior to the emotional disclosure exercise and facilitate if necessary during the sharing. Each member of the couple will take turn in sharing with and listening to their partner. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. Receives: Behavioral: Mindfulness Gratitude (MG) |
| Mindfulness + Value-Based Living (MV) | Experimental | Session 2 for participants randomized to group MV will focus on learning strategies to live life according to their values. They will first engage in a reflection exercise to help identify their values, and then complete a worksheet. Couples will brain storm together strategies to ensure that their lives reflect their self-identified values. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. Receives: Behavioral: Mindfulness Value-Based Living (MV) |
| Attention Control (AC) | No intervention | For participants randomized to the AC condition, both sessions will focus on discussing issues and themes that emerge for couples, such as communication and perceived supportiveness. Utilizing a reflective listening approach, the interventionist will focus on encouraging participants to share concerns related to their daily experiences. Unlike in the MC, MG, and MV groups, the interventionist will not offer advice, support (other than reflective listening) or any other tools to participants. Additionally, the interventionist will not probe for deep emotional disclosure. Please see the appendix for the session outline. We believe a control group that discusses daily relationship-related concerns serves as an excellent comparison condition in this study since it is viewed as credible by participants and equates for time and attention as well as nonspecific treatment effects such as those provided through social interactions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
Perceived Stress Scale (PSS) (Cohen \& Janicki-Deverts, 2012) is a 10-item scale to measure stress. Scores range from 0-40, with higher scores indicating greater perceived stress
Measured: Within 1 week of treatment ending
Perceived Stress Scale
Perceived Stress Scale (PSS) (Cohen \& Janicki-Deverts, 2012) is a 10-item scale to measure stress. Scores range from 0-40, with higher scores indicating greater perceived stress
Measured: 1 month after treatment ends
Secondary outcomes (4)
Dyadic Adjustment Scale Total Score
Dyadic Adjustment Scale (DAS-7) (Hunsley, Best, Lefebvre, \& Vito, 2001; Spanier, 1976) is a 7-item scale designed to measure adjustment and satisfaction among married or cohabitating couples. Scores range from 0 to 36, with a higher score indicating more positive relationship quality. It has been used in sample of college-aged couples in previous literature.
Measured: within 1 week of treatment ending
Dyadic Adjustment Scale Total Score
Dyadic Adjustment Scale (DAS-7) (Hunsley, Best, Lefebvre, \& Vito, 2001; Spanier, 1976) is a 7-item scale designed to measure adjustment and satisfaction among married or cohabitating couples. Scores range from 0 to 36, with a higher score indicating more positive relationship quality. It has been used in sample of college-aged couples in previous literature.
Measured: 1 month after treatment ends
Five Facet Mindfulness Scale Total Score
Five Facet Mindfulness Scale (FFMQ) (Baer, Smith, Hopkins, Krietemeyer, \& Toney, 2006) is a 39-item scale based on a factor analytic study of five independently developed mindfulness questionnaires, which yielded five factors of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Total scores range from 39-196 with higher scores indicating greater trait mindfulness.
Measured: Within 1 week of treatment completion
Five Facet Mindfulness Scale Total Score
Five Facet Mindfulness Scale (FFMQ) (Baer, Smith, Hopkins, Krietemeyer, \& Toney, 2006) is a 39-item scale based on a factor analytic study of five independently developed mindfulness questionnaires, which yielded five factors of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Total scores range from 39-196 with higher scores indicating greater trait mindfulness.
Measured: 1 month after treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start29 May 2019
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: Participant drop out exceeded expectations (out of 63 couples randomized, 18 completed follow up). Study may be resumed with revised procedures for preventing drop out.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The intervention conditions are divided into Mindfulness + Compassion (MC), Mindfulness + Gratitude (MG), Mindfulness + Value-Based Living (MV), and Attention Control (AC)) on Mindfulness (FFMQ).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sam Houston State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chelsea Ratcliff, Sam Houston State University
- Investigators
- Chelsea G Ratcliff, Ph.D., Principal investigator, Sam Houston State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026372
- Sponsor's protocol ID
- IRB-2019-123
- Status last verified
- Apr 2023
- First submitted
- 23 Aug 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Session Couples Class to Improve Relationship Health
- ClinicalTrials.gov ID
- NCT05026372
- Acronym / sponsor ID
- IRB-2019-123
- Conditions
- Stress
- Keywords
- couples stress, health, psychology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant drop out exceeded expectations (out of 63 couples randomized, 18 completed follow up). Study may be resumed with revised procedures for preventing drop out.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sam Houston State UniversityUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Aug 2021 (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 study will compare the effect of three different stress reduction intervention techniques compared to a non-intervention control group on the psychological and relationship functioning in 40 romantic couples. The current study will serve two purposes. Results will inform future efforts to develop effective brief stress reduction interventions for physically healthy couples and will inform future iterations of stress reduction-based intervention for cancer patients and their caregivers.
The investigators hypothesize that couples in the three stress-reduction interventions will report greater relationship health and greater mindfulness after the intervention than couples in the non-intervention control group. The investigators also hypothesize that the stress-reduction groups will be most beneficial for individuals who report higher distress, indifferent relationship style, and insecure attachment at baseline.
Detailed description
Participants will be randomly assigned to one of four conditions, each of which involve participating in two 45-minute sessions (via Zoom) with a study interventionist. Sam Houston State University (SHSU) clinical psychology master's or doctoral students or graduates of the SHSU clinical psychology master's program will implement the mind-body intervention, under the supervision of Dr. Chelsea Ratcliff, who is a licensed psychologist. Dr. Ratcliff will provide weekly group supervision to all students implementing the treatment.
Participation in this study will last a total of 6 weeks (+/- 1 week). The T1 survey will last approximately 45 minutes. Within 1 week of both partners completing baseline, eligible dyads will be scheduled for Session 1. For the intervention, all participants will be emailed a PDF of the appropriate workbook prior to Session 1. Participants will also be informed that they may pick up a hard copy (printed version).
For participants in the stress-reduction groups, after each session the interventionist will send each participant an email with: 1) the audio recording of the appropriate guided stress-reduction activity (transcript provided in workbook), 2) a fillable PDF document with instructions regarding completing and documenting home-practice, and 3) a link to a Qualtrics survey that asks them to evaluate their experience in the session. The instructor will also inform participants that they may pick up hard copies of all session materials if it is convenient/preferable. For participants in the non-intervention control group, the interventionist will email each participant a link to a Qualtrics survey that asks them to evaluate their experience in the session.
Session 2 will take place approximately 1 week after Session 1. After completing session 2, the interventionist will send a link to another Qualtrics survey that asks them to evaluate their experience in the session.
Within 1 week of completing Session 2, both members of the dyad will be emailed the link to the second Qualtrics survey (T2), which will last approximately 30 minutes. Finally, within 1 month (+/- 1 week) of completing Session 2, both members of the dyad will be emailed the third Qualtrics survey (T3), which will last approximately 20 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The intervention conditions are divided into Mindfulness + Compassion (MC), Mindfulness + Gratitude (MG), Mindfulness + Value-Based Living (MV), and Attention Control (AC)) on Mindfulness (FFMQ).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness + Compassion (MC) | Experimental | Behavioral: Mindfulness Compassion (MC)For participants randomized to the MC condition will focus on compassion and creating positive emotions. This session will include techniques such as guided visualizations and a loving kindness meditation that are intended to facilitate connection with their partners. During this session, couples will also learn the ground rules of mindful and compassionate listening and sharing, as they will be asked to engage in an emotional disclosure task. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. |
| Mindfulness + Gratitude (MG) | Experimental | Behavioral: Mindfulness Gratitude (MG)Session 2 for participants randomized to group MG will focus on gratitude. Participants will be taught to reflect on things, events, and people which they are grateful for via a gratitude meditation. Couples will share their experiences of practicing gratitude. The instructor will remind the couple of ground rules prior to the emotional disclosure exercise and facilitate if necessary during the sharing. Each member of the couple will take turn in sharing with and listening to their partner. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. |
| Mindfulness + Value-Based Living (MV) | Experimental | Behavioral: Mindfulness Value-Based Living (MV)Session 2 for participants randomized to group MV will focus on learning strategies to live life according to their values. They will first engage in a reflection exercise to help identify their values, and then complete a worksheet. Couples will brain storm together strategies to ensure that their lives reflect their self-identified values. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. |
| Attention Control (AC) | No intervention | –For participants randomized to the AC condition, both sessions will focus on discussing issues and themes that emerge for couples, such as communication and perceived supportiveness. Utilizing a reflective listening approach, the interventionist will focus on encouraging participants to share concerns related to their daily experiences. Unlike in the MC, MG, and MV groups, the interventionist will not offer advice, support (other than reflective listening) or any other tools to participants. Additionally, the interventionist will not probe for deep emotional disclosure. Please see the appendix for the session outline. We believe a control group that discusses daily relationship-related concerns serves as an excellent comparison condition in this study since it is viewed as credible by participants and equates for time and attention as well as nonspecific treatment effects such as those provided through social interactions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ADULT ROMANTIC COUPLES in a relationship for a minimum of 6 months COHABITATING for a minimum of 6 months STRESS. At least one member of the romantic dyad reports stress above the normative mean for young adults (i.e., Perceived Stress Scale score > 17; Cohen \& Janicki-Deverts, 2012).
Key exclusion criteria (2 listed)
- INDIVIDUALS UNDER AGE 18: This study only involves adult participants. NON-ENGLISH SPEAKING INDIVIDUALS: This study only involves participants who can speak English.
- ATTENDING PSYCHOTHERAPY: This stud only involves individuals who are not currently (self-defined) participating in psychotherapy.
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 |
|---|---|---|
| Mindfulness Compassion (MC)The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. | Behavioural | Mindfulness + Compassion (MC) |
| Mindfulness Gratitude (MG)The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. | Behavioural | Mindfulness + Gratitude (MG) |
| Mindfulness Value-Based Living (MV)The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist. | Behavioural | Mindfulness + Value-Based Living (MV) |
Primary outcome
Perceived Stress Scale
Time frame: Within 1 week of treatment ending
Perceived Stress Scale (PSS) (Cohen \& Janicki-Deverts, 2012) is a 10-item scale to measure stress. Scores range from 0-40, with higher scores indicating greater perceived stress
Perceived Stress Scale
Time frame: 1 month after treatment ends
Perceived Stress Scale (PSS) (Cohen \& Janicki-Deverts, 2012) is a 10-item scale to measure stress. Scores range from 0-40, with higher scores indicating greater perceived stress
4 secondary outcomes
Dyadic Adjustment Scale Total Score
Time frame: within 1 week of treatment ending
Dyadic Adjustment Scale Total Score
Time frame: 1 month after treatment ends
Five Facet Mindfulness Scale Total Score
Time frame: Within 1 week of treatment completion
Five Facet Mindfulness Scale Total Score
Time frame: 1 month after treatment ends
Results and safety
The study was stopped early (reason given: Participant drop out exceeded expectations (out of 63 couples randomized, 18 completed follow up). Study may be resumed with revised procedures for preventing drop out.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- 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.
Chelsea G Ratcliff, Ph.D. principal investigator
Sam Houston State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Compassion (MC), Mindfulness Gratitude (MG) and Mindfulness Value-Based Living (MV) in people with Stress, run by Sam Houston State University 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 1 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: stopped early, as of the sponsor's last update on 24 Oct 2023. 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 was stopped early (reason given: Participant drop out exceeded expectations (out of 63 couples randomized, 18 completed follow up). Study may be resumed with revised procedures for preventing drop out.). Results are not available in the source record.
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?
Perceived Stress Scale (time frame: Within 1 week of treatment ending). The study lists 2 primary outcomes in all. 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 24 Oct 2023.