Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- Change in depression symptoms
研究概览
简要总结
The purpose of this study is to assess the efficacy of an LGBTQ-affirmative individual cognitive behavioral psychotherapy (CBT) and LGBTQ-affirmative family therapy (attachment-based family therapy for sexual and gender minority young adults; ABFT-SGM) delivered via telehealth to a sample of sexual and gender minority adults with nonaccepting parent(s) in New York, Pennsylvania, Connecticut, and Israel. The investigators will assess whether both treatments are associated with significant decreases in depressive and anxiety symptoms. The investigators will also assess whether and how each treatment achieves reductions in mental health symptoms through specific mechanisms (e.g., rejection sensitivity, internalized stigma, emotion dysregulation, parental rejection and acceptance).
详细描述
The purpose of this study is to assess the efficacy and purported change mechanisms in an LGBTQ-affirmative individual cognitive behavioral psychotherapy (CBT) and LGBTQ-affirmative family therapy (attachment-based family therapy for sexual and gender minority young adults; ABFT-SGM) delivered via telehealth to a sample of sexual and gender minority adults in New York, Pennsylvania, Connecticut, and Israel. In this 2-arm randomized clinical trial (RCT), participants will receive 16 weekly sessions of either LGBTQ-affirmative CBT or ABFT-SGM. Investigators will assess whether both treatments are associated with significant decreases in depressive and anxiety symptoms. Investigators will also assess whether psychosocial mechanisms (e.g., rejection sensitivity, internalized stigma, emotion dysregulation, parental rejection and acceptance) mediate reductions in psychological symptoms, and whether such mediators differ between the two treatments. Finally, investigators will assess whether participants who begin treatment with higher levels of parental rejection benefit more from ABFT-SGM than from LGBTQ-affirmative CBT, and whether participants with higher initial levels of maladaptive stress responses benefit more from LGBTQ-affirmative CBT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be immediately assigned to either condition.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 20 and older
- •be fluent in English
- •self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
- •currently experience elevated depressive or anxiety symptoms (screened initially using a cutoff of ≥ 2.5 on the Brief Symptom Inventory-4 and further confirmed by the BDI and BAI).
- •report at least moderate levels of parental rejection or low levels of parental acceptance, as measured using the PARSOS.
- •have at least one rejecting/nonaccepting parent that agrees to participate in the therapy.
- •live in New York State, Pennsylvania, Connecticut, or Israel.
排除标准
- •report current mental health treatment ≥1 day/month (except for medication management ≤1 day/week)
- •report beginning a new medication within the past 30 days
- •exhibit active psychosis or active mania, as assessed by the SCID-Psych Screen.
- •exhibit active suicidality or active homicidality, as assessed by the SIDAS
- •be currently legally mandated to attend treatment
- •demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status
- •do not have a parent willing to participate
结局指标
主要结局
Change in depression symptoms
时间窗: Baseline, Immediate Post-intervention, 5-month Post-intervention
Depressive symptoms will be measured using the 21-item Beck Depression Inventory-II (BDI). Items are rated on a scale from 0-3 where higher scores indicate greater depression symptoms, with a maximum score of 63.
Change in anxiety symptoms
时间窗: Baseline, Immediate Post-intervention, 5-month Post-intervention
Anxiety symptoms will be measured using the 21-item Beck Anxiety Inventory (BAI). Items are rated on a scale from 0-3 where higher scores indicate greater anxiety symptoms, with a maximum score of 63.
次要结局
- Change in sexual orientation and gender modality acceptance concerns, as relevant(Baseline, Immediate Post-intervention, 5-month Post-intervention)
- Change in quality of attachment relationship(Baseline, Immediate Post-intervention, 5-month Post-intervention)
- Change in explicit internalized stigma(Baseline, Immediate Post-intervention, 5-month Post-intervention)
- Change in emotion dysregulation(Baseline, Immediate Post-intervention, 5-month Post-intervention)
- Change in implicit sexual orientation bias(Baseline, Immediate Post-intervention)
- Change in parental rejection of sexual orientation or gender modality, as relevant(Baseline, Immediate Post-intervention, 5-month Post-intervention)
- Change in suicidal ideation(Baseline, Immediate Post-intervention, 5-month Post-intervention)
- Change in sexual orientation and gender modality concealment motivation, as relevant(Baseline, Immediate Post-intervention, 5-month Post-intervention)
- Change in parental acceptance of sexual orientation or gender modality, as relevant(Baseline, Immediate Post-intervention, 5-month Post-intervention)