TY - JOUR
T1 - Adaption of tele-behavioral activation to increase physical activity in depression
T2 - Protocol for iterative development and evaluation
AU - Rethorst, Chad D.
AU - Trombello, Joseph M.
AU - Chen, Patricia
AU - Carmody, Thomas J.
AU - Lazalde, Alejandra
AU - Trivedi, Madhukar H.
N1 - Funding Information:
The work is supported by the National Institute of Mental Health [ R34MH122640 , PIs: Trivedi & Rethorst.
Publisher Copyright:
© 2023
PY - 2023/6
Y1 - 2023/6
N2 - Background: Poor treatment outcomes, disease recurrence, and medical co-morbidities contribute to the significant burden caused by depressive disorders. Increasing physical activity in persons with depression has the potential to improve both depression treatment outcomes and physical health. However, evidence for physical activity interventions that can be delivered as part of depression treatment remains limited. This study will examine a Behavioral Activation teletherapy intervention adapted to include a specific focus on increasing physical activity. Methods: The two-phase study will include a preliminary pilot study (n = 15) to evaluate and refine the manualized intervention using a mixed-methods approach followed by a single-arm study to evaluate feasibility and preliminary efficacy of the adapted BA teletherapy. Participants will be adults, age 18–64, with moderate to severe depressive symptoms (defined as a PHQ-9 score ≥10) and who currently engage in 90 min or less of moderate-to-vigorous physical activity. Individuals will be excluded if they have a current or past manic or hypomanic episode, psychosis, schizophrenia or schizophreniform disorder, or active suicidal ideation, or if not medically-cleared to exercise. The BA intervention will consist of 8 weekly sessions, followed by 2 bi-weekly booster sessions. Feasibility outcomes will include metrics of screening, enrollment, intervention adherence and fidelity, and participant retention. Intervention preliminary efficacy will be evaluated through assessment of changes in depressive symptoms and moderate-to-vigorous physical activity. Conclusion: Data from this trial will be used to support the conduct of a randomized controlled trial to evaluate the efficacy of the adapted BA intervention.
AB - Background: Poor treatment outcomes, disease recurrence, and medical co-morbidities contribute to the significant burden caused by depressive disorders. Increasing physical activity in persons with depression has the potential to improve both depression treatment outcomes and physical health. However, evidence for physical activity interventions that can be delivered as part of depression treatment remains limited. This study will examine a Behavioral Activation teletherapy intervention adapted to include a specific focus on increasing physical activity. Methods: The two-phase study will include a preliminary pilot study (n = 15) to evaluate and refine the manualized intervention using a mixed-methods approach followed by a single-arm study to evaluate feasibility and preliminary efficacy of the adapted BA teletherapy. Participants will be adults, age 18–64, with moderate to severe depressive symptoms (defined as a PHQ-9 score ≥10) and who currently engage in 90 min or less of moderate-to-vigorous physical activity. Individuals will be excluded if they have a current or past manic or hypomanic episode, psychosis, schizophrenia or schizophreniform disorder, or active suicidal ideation, or if not medically-cleared to exercise. The BA intervention will consist of 8 weekly sessions, followed by 2 bi-weekly booster sessions. Feasibility outcomes will include metrics of screening, enrollment, intervention adherence and fidelity, and participant retention. Intervention preliminary efficacy will be evaluated through assessment of changes in depressive symptoms and moderate-to-vigorous physical activity. Conclusion: Data from this trial will be used to support the conduct of a randomized controlled trial to evaluate the efficacy of the adapted BA intervention.
KW - Behavioral activation
KW - Depression
KW - Physical activity
KW - Psychotherapy
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U2 - 10.1016/j.conctc.2023.101103
DO - 10.1016/j.conctc.2023.101103
M3 - Article
C2 - 37128575
AN - SCOPUS:85152729126
SN - 2451-8654
VL - 33
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 101103
ER -