Impact of Exercise Groups on Patient Mental Health and Wellbeing in an Acute Psychiatric Inpatient Unit

NCT05859204 | Enrolling By Invitation

• 1 other identifier: IRB00373975
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

More research is needed to elucidate the impacts of physical activity interventions on short- and long-term activity and neuropsychiatric symptoms (NPS) in psychiatric inpatients and to support its advantageousness when compared to current standards of care. To investigate the impact of regular exercise on activity level, NPS, and sleep in an inpatient psychiatry unit, the investigators propose a placebo-controlled study with measures of activity, mood, anxiety, energy, and sleep as primary outcomes in 50 psychiatric inpatients at Johns Hopkins Hospital. Given the challenges of maintaining blinded assignment to treatment arm, the investigators will compare patients during two time periods (3 months each): the first is treatment as usual (TAU), the second adds exercise intervention (EXI).

Conditions

Psychiatric Hospitalization; Physical Inactivity; Depression, Anxiety; Sleep

Outcome Measures

Primary Outcomes (3)

• Change in depression using Patient Health Questionnaire-9

  Patient Health Questionnaire-9, range 0-27, lower score better outcome

  baseline, time of discharge up to 6 months

• Change in anxiety using Generalized Anxiety Disorder-7

  Generalized Anxiety Disorder-7, range 0-21, lower score better outcome

  baseline, time of discharge up to 6 months

• Change in sleep using Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Index, range 0-21, lower score better outcome

  baseline, time of discharge up to 6 months

Secondary Outcomes (1)

• Length of Stay

  time of discharge up to 6 months

Study Arms (2)

OT-led Exercise Group on Inpatient Psychiatry Unit

EXPERIMENTAL

Occupational therapist (OT) led group. Group includes education, warm-up, high intensity interval training cardio, strength, kick boxing, cool-down, yoga, and discussion. This group also receives the Treatment as Usual groups.

Behavioral: OT-led Exercise Group

Treatment As Usual - OT Groups on Inpatient Psychiatry Unit

PLACEBO COMPARATOR

An occupational therapist (OT) will begin daily educational session about the topic of choice for that day.

Behavioral: Treatment as Usual - OT Groups

Interventions

OT-led Exercise Group BEHAVIORAL

Participants will complete pre-intervention self-report surveys about mood, anxiety, energy, self-esteem, and activity handed out by the research team. At this point, an occupational therapist (OT) will begin 10-minute educational session that describes the purpose of the exercise intervention and methods to remain safe during the intervention such as self-monitoring techniques. Following completion of the educational session, participants will complete a 30-minute exercise intervention under the guidance of the OT, which includes warm-up, high intensity interval training cardio, strength, kick boxing, cool-down, and yoga. Following completion of the exercise regimen, participants will participate in a 10-minute discussion and reflection with the OT and complete post-intervention self-report surveys. Participants in the intervention arm will also receive routine daily occupational therapy educational sessions received by the treatment as usual arm.

OT-led Exercise Group on Inpatient Psychiatry Unit

Treatment as Usual - OT Groups BEHAVIORAL

Participants will complete pre-session self-report surveys about mood, anxiety, energy, self-esteem, and activity handed out by the research team. At this point, an occupational therapist (OT) will begin daily educational session about the topic of choice for that day. Treatment groups are largely discussion-based and include the following topics: coping skills, self-esteem, sleep management, leisure, time management, life skills, decision making, and goal setting. Following completion of the educational session, participants will complete post-intervention self-report surveys.

Treatment As Usual - OT Groups on Inpatient Psychiatry Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psychiatric inpatients admitted to the Johns Hopkins Bayview Acute Psychiatric Unit (APU)
• Aged 18 years or older
• Able to give informed consent and understand the tasks involved
• In the opinion of the unit attending, the patient is sufficiently psychologically or medically stable to safely participate in the exercise intervention

You may not qualify if:

• Patients who do not speak English as their primary language.
• Patients with a history of physical or neurological conditions that interfere with study procedures.
• Patients demonstrating behavior that would be a safety concern if placed in a group at the discretion of occupational therapy, the medical team, or the nursing team.
• A patient can be excluded if in the opinion of the treatment team on the unit, participation in the study would have a negative impact on the patient's mental health or treatment plan.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Matthew E Peters, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 15, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (1)