Clinical trial · Observational
Depression and Body Image Distress Following Mastectomy With Reconstruction
Risk and Protective Factors for Depression and Body Image Distress Following Mastectomy With Breast Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychosocial variables | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast reconstruction patients
- description
- Self-reported psychosocial variables and a clinical interview assessing mental health history will be administered prior to participants' scheduled mastectomy and breast reconstruction surgery (which is part of their routine medical care for cancer treatment or prevention). Follow up self-report measures will be collected after the surgery as well.
- interventionNames
- Other: Psychosocial variables
Primary outcomes (2)
- measure
- Body Image Scale (BIS)
- timeFrame
- 2-3 months post-surgery (i.e., Time 2)
- description
- Assesses severity of body image distress related to breast cancer treatment with a summed total score, which ranges from 0 (no body image distress) to 30 (substantial body image distress).
- measure
- Beck Depression Inventory-II (BDI-II)
- timeFrame
- 2-3 months post-surgery (i.e., Time 2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female adults (age 18+) who are scheduled for mastectomy with immediate breast reconstruction at the Massachusetts General Hospital (MGH) Plastic and Reconstructive Surgery Program 2. English language proficiency 3. Ability to provide informed consent. Exclusion Criteria: 1. Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder 2. Current active suicidal ideation 3. Current treatment plan includes radiation and/or ongoing chemotherapy 4. Does not have access to Internet at home, required to complete study questionnaires
References
Publications (1)
- DERIVEDWeingarden H, Laky ZE, Ladis I, Austen WG Jr, Wilhelm S. Body Image After Mastectomy Scale: A New Measure of Body Image Behaviors and Beliefs in Women Following Mastectomy. J Womens Health (Larchmt). 2022 Jan;31(1):47-54. doi: 10.1089/jwh.2021.0131. Epub 2021 Aug 26. PMID 34449252