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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05859204
Status
Enrolling By Invitation

Conditions

  • Depression, Anxiety
  • Physical Inactivity
  • Psychiatric Hospitalization
  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Aug 1, 2023
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: OT-led Exercise Group on Inpatient Psychiatry Unit
    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.
  • Placebo Comparator: Treatment As Usual - OT Groups on Inpatient Psychiatry Unit
    An occupational therapist (OT) will begin daily educational session about the topic of choice for that day.

Primary Outcome Measure

Change in depression using Patient Health Questionnaire-9 [ Time Frame: baseline, time of discharge up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224-

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Johns Hopkins Bayview Medical Center· Baltimore, MD

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