Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT02480192
Eligibility Criteria:
Inclusion Criteria:
1. Menopausal staging: perimenopause or postmenopausal as per STRAW definitions (Harlow et al., 2012) or having surgically-induced menopause
2. A minimum of mild level of severity of depressive symptoms (defined by the Beck Depression Inventory, scores of 14 or greater during initial screen),
3. Significant vasomotor symptoms: i.e., vasomotor symptoms that are (a) frequent (≥ 4 hot flashes per day/night or 21 or more per week); (b) distressing (≥ 3 or more on the vasomotor subscale of the Greene Climacteric Scale); and (c) interfering (≥ 30 or greater on the Hot Flash Related Daily Interference Scale).
4. Not taking hormonal, anti-depressant, or any herbal therapies or if taking these medications they must be taking a stable dose for at least three months prior to the study and for the duration of the study,
5. Speak, read, and write in English sufficiently to comprehend testing procedures and written materials in group treatment.
Exclusion Criteria:
1. Participants who are severely depressed/suicidal at the time of the screen or intake assessment that would warrant acute treatment and hence, render them unable to act as a wait list control participant if randomized to this condition,
2. Participants with Psychotic Disorders, or current Substance Dependence.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT02480192
Study Brief:
Protocol Section:
NCT02480192