Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Emory University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized pilot study of the use of cognitive behavior therapy versus observation to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.
The study enrollment was completed in 2003. The study results are being analyzed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavior therapy | Experimental | Cognitive behavior therapy consisting of 16 sessions over 20 weeks |
|
| observation | Placebo Comparator | Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavior therapy | Behavioral | 16 sessions of 45 minutes each to review stress management |
|
| Measure | Description | Time Frame |
|---|---|---|
| ovarian function | The change in ovarian function was assessed by comparing ovarian function before and after 20 weeks of CBT or observation using menses and serial estradiol and progesterone level as indices of ovarian function | Change before and after 20 weeks of CBT or observation |
| Measure | Description | Time Frame |
|---|---|---|
| metabolism | The change in metabolism was assessed by measuring levels of cortisol, TSH, T4, free T4, T3, free T3, leptin in blood and by measuring weight before and after 20 weeks of CBT or observation | Change before and after 20 weeks of CBT or observation |
| Measure | Description | Time Frame |
|---|---|---|
| psychological inventories | Attitudes were assessed before and after 20 weeks of CBT or observation using psychological inventories | Change before and after 20 weeks of CBT or observation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah L Berga, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14556820 | Result | Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5. | |
| 28453773 | Derived | Kawwass JF, Sanders KM, Loucks TL, Rohan LC, Berga SL. Increased cerebrospinal fluid levels of GABA, testosterone and estradiol in women with polycystic ovary syndrome. Hum Reprod. 2017 Jul 1;32(7):1450-1456. doi: 10.1093/humrep/dex086. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 23507474 | Derived | Michopoulos V, Mancini F, Loucks TL, Berga SL. Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized, controlled trial. Fertil Steril. 2013 Jun;99(7):2084-91.e1. doi: 10.1016/j.fertnstert.2013.02.036. Epub 2013 Mar 16. |