Enhancing Therapy Process With Movement Strategies

NCT03140124 | Terminated

• 1 other identifier: 3889
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies have noted the benefits of exercise programs in improving both mood and anxiety symptoms. Additionally, single bouts of exercise have been shown to improve mood and anxiety. Business applications report ancillary benefits of exercise as well. For example, individuals spontaneously report better ability to approach stimuli and cope with emotional experiences if doing it while exercising. The current study aims to investigate exercise during a therapy session as a potential intervention for enhancing therapeutic learning, particularly ability to better cope with emotional topics and experiencing intense emotions. In this study, patient participants will complete a therapy session while using an exercise machine and a separate therapy session while using a worry stone (control). Both patient participants and therapist participants will make ratings of a variety of items, including ability to discuss emotional topics and comfort in experiencing emotions. Investigators hypothesize that patients will report better ability to discuss emotional topics and more comfort in experiencing emotions following the exercise condition as opposed to the worry stone condition. Investigators also hypothesize that therapist ratings will similarly indicate that patients were better able to discuss emotional topics and experience emotional content during exercise sessions.

Conditions

Anxiety Disorders; Mood Disorders

Outcome Measures

Primary Outcomes (2)

• Session Rating Scale - Patient version (Questions 1 and 2)

  Patients will be asked questions on a 1 to 5 Likert scale examining degree to which they discussed emotional topics during session (Question 1) and the degree to which they felt comfortable discussing emotional topics during session (Question 2).

  Change throughout 50-minute therapy session.

• Session Rating Scale - Therapist version (Questions 1 and 2)

  Therapists will be asked questions on a 1 to 5 Likert scale examining degree to which they felt their patients discussed emotional topics during session (Question 1) and the degree to which they felt their patients were comfortable discussing emotional topics during session (Question 2).

  Change throughout 50-minute therapy session.

Secondary Outcomes (9)

• Positive and Negative Affect Schedule - Patient

  Change throughout 50-minute therapy session.

• Positive and Negative Affect Schedule - Therapist

  Change throughout 50-minute therapy session.

• Affect Grid - Patient

  Change throughout 50-minute therapy session.

• Affect Grid - Therapist

  Change throughout 50-minute therapy session.

• Credibility-Expectations Questionnaire - Patient

  Change throughout 50-minute therapy session.

Study Arms (2)

Group 1

OTHER

First session: worry stone, second session: exercise peddler

Behavioral: Exercise; Behavioral: Worry Stone

Group 2

OTHER

First session: exercise peddler, second session: worry stone

Behavioral: Exercise; Behavioral: Worry Stone

Interventions

Exercise BEHAVIORAL

Each participant will be provided with an ActiveLife Trainer to use during visit 2 or 3. The ActiveLife Trainer is a stationary pedaling machine that one can use while seated. It was designed to be used while working and makes very little noise. It is a safe, low-impact physical activity machine with adjustable resistance. The machine communicates via Bluetooth with the Wahoo Fitness app which records activity metrics such as distance cycled. Participants will be provided with a tablet on which the Wahoo Fitness app will track their exercise during the session. The ActiveLife Trainer has been used in numerous research studies (Carr et al., 2014; Botter et al., 2013; Burford et al., 2013; Carr et al., 2013).

Group 1; Group 2

Worry Stone BEHAVIORAL

For the worry stone condition, both the participants will rub a stone for the duration of the session. Each participant will be provided with a worry stone to rub during visit 2 or 3. These are small sooth stones that fit in the palm of one's hand.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over the age of 18
• Ability to read and provide informed consent
• Current patient or therapist at the Center for Anxiety and Related Disorders (CARD)
• Ability to complete exercise (e.g. no physical injuries)

You may not qualify if:

• Participants considered high risk based on the ACSM risk stratification guidelines (derived from PAR-Q)
• Participants with current knee, ankle, hip, or foot injuries that could impede exercise on the machine or participants with current hand or wrist injuries that could impede use of the worry stone

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Participants receive both conditions, with randomized order

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: May 4, 2017
• Study Start: November 3, 2015
• Primary Completion: March 6, 2017
• Study Completion: March 6, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)