Anxiety, Depression
Conditions
Keywords
coping, intervention, waiting-period
Brief summary
Background of the study: Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman and her partner. Most stressful for the couple is waiting for the result of the treatment, the period after the embryotransfer until the pregnancy test or menstruation and an unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp copingintervention has been developed based on the stress theory of Lazarus for women to use at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal. Research has demonstrated that using this copingstyle can have a positive impact in health related circumstances.
Detailed description
Objective of the study: To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or ICSI treatment in the UMCU during the waitingperiod after an embryotransfer. Study design: In this research a randomised controlled trial (RCT) will be used for three groups. The choice for three groups has been based on earlier research with a daily record keeping (DRK). The DRK is a daily measurement for emotions, copingstyle and physical complaints. Previous research with the DRK showed an increase of anxiety. More research must be done of the impact of the DRK. Group 1: Positive Reappraisal Coping Intervention (PRCI) & DRK & questionnaires Group 2: DRK & questionnaires Group 3: Standard care & questionnaires Study population: Patients undergoing an IVF or ICSI treatment in the UMCU. Intervention (if applicable): A selfhelp coping intervention Primary study parameters/outcome of the study: Anxiety Secondary study parameters/outcome of the study (if applicable): Risk of emotional problems copingstyle depression vital pregnancy quality of life Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): Using the coping intervention may reduce anxiety for the patient. The use of this instrument is not a burden for patients. The burden for patients is to complete questionnaires before, during and six weeks after the embryotransfer. Partners are asked to fill in a questionnaire at three times.
Interventions
BEHAVIORALCoping intervention
Positive reappraisal coping intervention
Sponsors
Bart CJM Fauser
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Patient in IVF/ICSI treatment
Exclusion criteria
* Patient who do not speak the dutch language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer | The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer | The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression. |
Countries
Netherlands
Participant flow
Recruitment details
In the 20 months of recruitment, between October 2010 and June 2012, 1445 letters were sent to women with an invitation to the trial.
Pre-assignment details
Of the 565 women who replied via a letter or email, 188 (33%) were not eligible. The remaining 377 women were randomised and the 349 who had an embryo to transfer (n=119 PRCI-monitoring, n=117 monitoring-control, n=113 routine care control)
Participants by arm
| Arm | Count |
|---|---|
| PRCI-monitoring Group Coping intervention, Daily Record Keeping, Questionnaires
Coping intervention, Daily Record Keeping, Questionnaires : | 127 |
| Monitoring-control Group DRK and Questionnaires
Coping intervention, Daily Record Keeping, Questionnaires : | 126 |
| Routine Care Control Group Questionnaires
Coping intervention, Daily Record Keeping, Questionnaires : | 124 |
| Total | 377 |
Baseline characteristics
| Characteristic | PRCI-monitoring Group | Monitoring-control Group | Routine Care Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 4.7 | 34.6 years STANDARD_DEVIATION 4.7 | 34.8 years STANDARD_DEVIATION 5 | 34.8 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment Netherlands | 127 participants | 126 participants | 124 participants | 377 participants |
| Sex: Female, Male Female | 127 Participants | 126 Participants | 124 Participants | 377 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 127 | 0 / 126 | 0 / 124 |
| serious Total, serious adverse events | 0 / 127 | 0 / 126 | 0 / 124 |
Outcome results
Primary
Anxiety
The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
Time frame: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
Population: Only in women with embryo transfer
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRCI-monitoring Group | Anxiety | Time 2 | 7.302 units on a scale | Standard Error 0.269 |
| PRCI-monitoring Group | Anxiety | Time 1 | 6.279 units on a scale | Standard Error 0.242 |
| PRCI-monitoring Group | Anxiety | Time 3 | 5.798 units on a scale | Standard Error 0.279 |
| Monitoring-control Group | Anxiety | Time 2 | 7.526 units on a scale | Standard Error 0.249 |
| Monitoring-control Group | Anxiety | Time 1 | 6.223 units on a scale | Standard Error 0.243 |
| Monitoring-control Group | Anxiety | Time 3 | 5.571 units on a scale | Standard Error 0.262 |
| Routine Care Control Group | Anxiety | Time 1 | 6.095 units on a scale | Standard Error 0.251 |
| Routine Care Control Group | Anxiety | Time 3 | 6.317 units on a scale | Standard Error 0.288 |
| Routine Care Control Group | Anxiety | Time 2 | 8.175 units on a scale | Standard Error 0.272 |
Comparison: IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.p-value: <0.05Mixed Models Analysis
Comparison: To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.p-value: <0.05Mixed Models Analysis
Secondary
Depression
The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
Time frame: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
Population: Only in women with embryo transfer
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRCI-monitoring Group | Depression | Time 3 | 3.983 units on a scale | Standard Error 0.23 |
| PRCI-monitoring Group | Depression | Time 2 | 3.709 units on a scale | Standard Error 0.222 |
| PRCI-monitoring Group | Depression | Time 1 | 3.389 units on a scale | Standard Error 0.199 |
| Monitoring-control Group | Depression | Time 1 | 3.391 units on a scale | Standard Error 0.201 |
| Monitoring-control Group | Depression | Time 3 | 3.708 units on a scale | Standard Error 0.216 |
| Monitoring-control Group | Depression | Time 2 | 3.676 units on a scale | Standard Error 0.206 |
| Routine Care Control Group | Depression | Time 3 | 3.736 units on a scale | Standard Error 0.238 |
| Routine Care Control Group | Depression | Time 2 | 4.224 units on a scale | Standard Error 0.225 |
| Routine Care Control Group | Depression | Time 1 | 3.269 units on a scale | Standard Error 0.208 |
Comparison: IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.p-value: <0.05Mixed Models Analysis