Anxiety, Depression
Conditions
Keywords
Anxiety, Depression, LGBTQ+, COVID-19, Brief intervention, Social support, Acceptance-based behavior therapy
Brief summary
The overall aim of this program of research is to improve the mental health of people who identify as LGBTQ+ by increasing their social support through a brief intervention. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (ABBT). To achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (TAU) vs. ABBT.
Detailed description
During the COVID-19 pandemic, up to 81% of adults in the United States experienced worsening mental health. A major cause was the social isolation triggered by the pandemic due to quarantining, loss of family or friends, and loss of work. For individuals who lost social connections or were unable to adapt to maintain their connections, social support decreased and loneliness worsened, putting them at much higher risk for anxiety and depressive symptoms. Importantly, people who identify as LGBTQ+ have been particularly affected by the social isolation caused by the pandemic and were already at much higher risk of social isolation, loneliness, and mental illness, including suicidality, before the pandemic. The objective of this R01 fully-powered trial is to examine the effectiveness of a brief acceptance-based behavioral telehealth intervention (ABBT) to improve mental health during the COVID-19 pandemic by strengthening social support among LGBTQ+ individuals. The aims of this proposal are: (1) to examine the effectiveness of ABBT in reducing mental health morbidity by conducting a fully-powered, RCT (n=240) of ABBT vs. Treatment-as-Usual; and, (2) to examine potential mediators and moderators of ABBT treatment effects. Primary outcomes will be anxiety and depressive symptoms.
Interventions
BEHAVIORALAcceptance-Based Behavior Therapy (ABBT)
In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified challenges related to the COVID-19 pandemic, mental health, and social support. Interventionists will help participants identify potential challenges to acceptance. At the second session, participants will practice acceptance-based coping skills and a social support behavioral plan will be developed. These discussions will help the participant clarify how best to align their values with decisions on how to manage their mental health and social support in the context of the COVID-19 pandemic.
TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication.
Sponsors
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded raters will conduct interviewer-rated assessments of anxiety and depression (primary outcomes)
Intervention model description
This is a 2-arm RCT.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Present to recruitment clinic for any type of clinical care * Identify as LGBTQ+ * Self-reported ≥ mild anxiety and/or depressive symptoms, based on the GAD-7 and PHQ-9 * 18 years or older * Ability to speak and read English
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) | 39 weeks | The interviewer-rated QIDS-C is a measure of depressive symptom severity. |
| Hamilton Anxiety Rating Scale (HAM-A) | 39 weeks | The interviewer-rated HAM-A is a measure of anxiety symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) | 39 weeks | The GAD-7 is a self-report measure of anxiety severity. |
| Patient Health Questionnaire-9 (PHQ-9) | 39 weeks | The PHQ-9 is a self-report measure of depression severity. |
Countries
United States
Outcome results
None listed