Trial Outcomes & Findings for Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women (NCT NCT01690897)
NCT ID: NCT01690897
Last Updated: 2024-12-13
Results Overview
Sexual distress will be measured with the revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.
Results posted on
2024-12-13
Participant Flow
Participant milestones
| Measure |
MBCT Group
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
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|---|---|---|
|
Overall Study
STARTED
|
70
|
78
|
|
Overall Study
COMPLETED
|
55
|
59
|
|
Overall Study
NOT COMPLETED
|
15
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
Baseline characteristics by cohort
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
Total
n=148 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 13.2 • n=70 Participants
|
37.9 years
STANDARD_DEVIATION 12.2 • n=78 Participants
|
38.6 years
STANDARD_DEVIATION 12.6 • n=148 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=70 Participants
|
78 Participants
n=78 Participants
|
148 Participants
n=148 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=70 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=70 Participants
|
1 Participants
n=78 Participants
|
1 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=70 Participants
|
71 Participants
n=78 Participants
|
138 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=70 Participants
|
6 Participants
n=78 Participants
|
9 Participants
n=148 Participants
|
|
Region of Enrollment
Canada
|
70 participants
n=70 Participants
|
78 participants
n=78 Participants
|
148 participants
n=148 Participants
|
|
Sexual Interest/Desire Inventory (SIDI)
|
16.99 units on a scale
STANDARD_DEVIATION 8.16 • n=64 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
15.41 units on a scale
STANDARD_DEVIATION 6.66 • n=69 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
16.17 units on a scale
STANDARD_DEVIATION 7.43 • n=133 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
|
Female Sexual Distress Scale-Revised (FSDS-R)
|
32.97 units on a scale
STANDARD_DEVIATION 11.27 • n=64 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
32.22 units on a scale
STANDARD_DEVIATION 7.99 • n=69 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
32.58 units on a scale
STANDARD_DEVIATION 9.68 • n=133 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
|
Relationship Assessment Scale (RAS)
|
3.87 units on a scale
STANDARD_DEVIATION 0.80 • n=64 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
4.14 units on a scale
STANDARD_DEVIATION 0.74 • n=69 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
4.01 units on a scale
STANDARD_DEVIATION 0.77 • n=133 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
|
Rumination-Reflection Questionnaire (RRQ)
|
3.08 units on a scale
STANDARD_DEVIATION .96 • n=64 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
3.00 units on a scale
STANDARD_DEVIATION .79 • n=69 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
3.04 units on a scale
STANDARD_DEVIATION .87 • n=133 Participants • Numbers assessed at baseline differed due to participants lost before treatment started or did not complete.
|
PRIMARY outcome
Timeframe: 2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.Population: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Sexual distress will be measured with the revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
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|---|---|---|
|
Female Sexual Distress Scale-Revised (FSDS-R)
Post-treatment
|
22.88 units on a scale
Standard Deviation 10.73
|
25.68 units on a scale
Standard Deviation 10.24
|
|
Female Sexual Distress Scale-Revised (FSDS-R)
6 Months
|
23.02 units on a scale
Standard Deviation 11.54
|
23.87 units on a scale
Standard Deviation 11.83
|
|
Female Sexual Distress Scale-Revised (FSDS-R)
12 Months
|
18.92 units on a scale
Standard Deviation 9.63
|
21.60 units on a scale
Standard Deviation 11.95
|
PRIMARY outcome
Timeframe: 2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.Population: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) will be used to measure sexual desire. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
|---|---|---|
|
Sexual Interest and Desire Inventory (SIDI)
Post treatment
|
27.91 units on a scale
Standard Deviation 9.81
|
23.62 units on a scale
Standard Deviation 9.91
|
|
Sexual Interest and Desire Inventory (SIDI)
6 Months
|
28.08 units on a scale
Standard Deviation 10.44
|
25.57 units on a scale
Standard Deviation 10.77
|
|
Sexual Interest and Desire Inventory (SIDI)
12 Months
|
29.85 units on a scale
Standard Deviation 9.78
|
26.76 units on a scale
Standard Deviation 11.51
|
PRIMARY outcome
Timeframe: 2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.Population: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Rumination was measured with the Rumination-Reflection Questionnaire - Adapted Rumination Subscale (adapted from Trapnell \& Campbell, 1999 to inquire about sexuality-related rumination). Likert scale 1 - 5 with higher score indicating higher rumination.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
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|---|---|---|
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Rumination
Post-treatment
|
2.60 units on a scale
Standard Deviation .72
|
2.71 units on a scale
Standard Deviation .92
|
|
Rumination
6 Months
|
2.32 units on a scale
Standard Deviation .72
|
2.81 units on a scale
Standard Deviation 1.01
|
|
Rumination
12 Months
|
2.23 units on a scale
Standard Deviation .72
|
2.47 units on a scale
Standard Deviation .99
|
PRIMARY outcome
Timeframe: 2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.Population: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988). Scoring: Add each item score and divide by 7 to get a mean score. Higher score relates to higher satisfaction. Minimum mean score 1, maximum score 5.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
|---|---|---|
|
Relationship Assessment Scale (RAS)
Post treatment
|
4.27 units on a scale
Standard Deviation 0.71
|
4.03 units on a scale
Standard Deviation 0.89
|
|
Relationship Assessment Scale (RAS)
6 Months
|
3.87 units on a scale
Standard Deviation .80
|
4.14 units on a scale
Standard Deviation .74
|
|
Relationship Assessment Scale (RAS)
12 Months
|
4.16 units on a scale
Standard Deviation .75
|
4.24 units on a scale
Standard Deviation .85
|
SECONDARY outcome
Timeframe: Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-IPopulation: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Subjects will indicate their levels of subjective arousal while undergoing arousal testing. A device manufactured for the UBC Sexual Health Lab called the "arousometer"- a computer mouse mounted on a metal track divided into 10 equally spaced intervals corresponding to "sexually turned off" (-2) to "the most sexually aroused you have ever been or could imagine being" (7). This device allows continuous self-report measurement of subjective sexual arousal while viewing the erotic films.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
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|---|---|---|
|
Subjective Sexual Arousal
Pre Treatment
|
2.96 score on a scale
Standard Deviation 1.53
|
3.21 score on a scale
Standard Deviation 1.37
|
|
Subjective Sexual Arousal
Post Treatment
|
3.93 score on a scale
Standard Deviation 1.48
|
3.74 score on a scale
Standard Deviation 1.4
|
|
Subjective Sexual Arousal
6 Months
|
3.8 score on a scale
Standard Deviation 1.53
|
3.77 score on a scale
Standard Deviation 1.53
|
|
Subjective Sexual Arousal
12 Months
|
3.78 score on a scale
Standard Deviation 1.46
|
3.73 score on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-IPopulation: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Interoceptive awareness will be measured using the Multidimensional Assessment of Interoceptive Awareness (MAIA; Mehling et al., 2012) questionnaire. Possible range of scores 0 - 5. Higher score means higher awareness.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
|---|---|---|
|
Interoceptive Awareness
Pre Treatment
|
2.60 score on a scale
Standard Deviation .72
|
2.74 score on a scale
Standard Deviation .60
|
|
Interoceptive Awareness
Post Treatment
|
3.15 score on a scale
Standard Deviation .57
|
2.9 score on a scale
Standard Deviation .58
|
|
Interoceptive Awareness
6 Months
|
3.08 score on a scale
Standard Deviation .63
|
2.89 score on a scale
Standard Deviation .66
|
|
Interoceptive Awareness
12 Months
|
3.19 score on a scale
Standard Deviation .63
|
2.96 score on a scale
Standard Deviation .62
|
SECONDARY outcome
Timeframe: Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-IPopulation: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Physiological sexual arousal will be measured with a Vaginal Photoplethysmograph (VPP) during exposure to erotic films. The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan \& Everaerd, 1995). There is no threashold on the millivolts (MV) reading.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
|---|---|---|
|
Physiological Sexual Arousal
Pre Treatment
|
.120 millivolts (mV)
Standard Deviation .093
|
.125 millivolts (mV)
Standard Deviation .091
|
|
Physiological Sexual Arousal
Post Treatment
|
.124 millivolts (mV)
Standard Deviation .099
|
.135 millivolts (mV)
Standard Deviation .100
|
|
Physiological Sexual Arousal
6 Months
|
.102 millivolts (mV)
Standard Deviation .070
|
.133 millivolts (mV)
Standard Deviation .089
|
|
Physiological Sexual Arousal
12 Months
|
.119 millivolts (mV)
Standard Deviation .095
|
.151 millivolts (mV)
Standard Deviation .100
|
SECONDARY outcome
Timeframe: Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-IPopulation: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
The diurnal cortisol slope is the difference in cortisol levels from morning to evening (PM minus AM). To assay salivary cortisol concentrations, samples were vortexed and centrifuged at 1,400 g for 10 minutes at 18°C. Salivary cortisol was measured using the commercially available High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (Salimetrics Assays, 1-3002, State College, PA) according to the standard protocol. The minimum amount of saliva required by this assay is 25 μl, and intra- and inter-assay coefficients of variation were 4.6% and 6.0%, respectively.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
|---|---|---|
|
Stress Hormone Cortisol Slope
Pre Treatment
|
.298 micrograms per decilitre (ug/dl)
Standard Deviation .062
|
.296 micrograms per decilitre (ug/dl)
Standard Deviation .063
|
|
Stress Hormone Cortisol Slope
Post Treatment
|
.285 micrograms per decilitre (ug/dl)
Standard Deviation .103
|
.283 micrograms per decilitre (ug/dl)
Standard Deviation .071
|
|
Stress Hormone Cortisol Slope
6 Months
|
.325 micrograms per decilitre (ug/dl)
Standard Deviation .139
|
.310 micrograms per decilitre (ug/dl)
Standard Deviation .087
|
|
Stress Hormone Cortisol Slope
12 Months
|
.309 micrograms per decilitre (ug/dl)
Standard Deviation .094
|
.287 micrograms per decilitre (ug/dl)
Standard Deviation .089
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-IPopulation: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Depression is measured with the Hamilton Depression Scale - Short Form (McIntyre et al., 2005). Seven questions on a scale of 0 - 4 with higher score meaning higher depression. Totals are summed with a possible range of scores from 0 - 28.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
|---|---|---|
|
Depression
Pre Treatment
|
4.44 score on a scale
Standard Deviation 3.47
|
4.70 score on a scale
Standard Deviation 3.62
|
|
Depression
Post Treatment
|
2.99 score on a scale
Standard Deviation 2.49
|
3.95 score on a scale
Standard Deviation 3.79
|
|
Depression
6 Months
|
2.85 score on a scale
Standard Deviation 3.18
|
3.47 score on a scale
Standard Deviation 3.60
|
|
Depression
12 Months
|
2.56 score on a scale
Standard Deviation 2.91
|
3.54 score on a scale
Standard Deviation 3.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-IPopulation: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Mindfulness will be measured with the Five Factor Mindfulness questionnaire (Baer, Smith, Hopkins, Krietemeyer \& Tony, 2006). Questions are answered on a 5-point Likert scale ranging from 1 to 5. Possible range of scores 39 to 195 with higher score meaning higher mindfulness.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
|---|---|---|
|
Mindfulness
Pre Treatment
|
123.76 score on a scale
Standard Deviation 18.02
|
126.02 score on a scale
Standard Deviation 17.95
|
|
Mindfulness
Post Treatment
|
134.47 score on a scale
Standard Deviation 17.49
|
126.19 score on a scale
Standard Deviation 17.67
|
|
Mindfulness
6 Months
|
131.92 score on a scale
Standard Deviation 17.79
|
127.66 score on a scale
Standard Deviation 19.16
|
|
Mindfulness
12 Months
|
138.06 score on a scale
Standard Deviation 18.27
|
130.89 score on a scale
Standard Deviation 19.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-IPopulation: Numbers adjusted due to participants lost before treatment, did not complete, scheduling difficulties, or removed from study.
Perceived stress will be measured with the Perceived Stress Scale (Cohen, Kamarck, \& Mermelstein, 1983). Questions are likert scale from 0 - 4. Possible range of scores 0 - 40 with higher score indicating higher stress.
Outcome measures
| Measure |
MBCT Group
n=70 Participants
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment: The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
|
Support Group
n=78 Participants
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment: The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
|
|---|---|---|
|
Perceived Stress
Pre Treatment
|
16.34 score on a scale
Standard Deviation 6.56
|
17.66 score on a scale
Standard Deviation 6.07
|
|
Perceived Stress
Post Treatment
|
14.1 score on a scale
Standard Deviation 6.25
|
16.5 score on a scale
Standard Deviation 7.6
|
|
Perceived Stress
6 Months
|
15.13 score on a scale
Standard Deviation 6.55
|
15.46 score on a scale
Standard Deviation 7.39
|
|
Perceived Stress
12 Months
|
12.99 score on a scale
Standard Deviation 6.14
|
16.51 score on a scale
Standard Deviation 7.46
|
Adverse Events
MBCT Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Support Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place