Enhancing Therapy Process With Movement Strategies

Anxiety Disorders Clinical Trial

Official title:

Enhancing Therapy Process With Movement Strategies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03140124
• Other study ID #: 3889
• Status: Terminated
• Phase: N/A
• First received: October 7, 2016
• Last updated: May 2, 2017
• Start date: November 3, 2015
• Est. completion date: March 6, 2017

Study information

• Verified date: May 2017
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 6, 2017
• Est. primary completion date: March 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults over the age of 18

2. Ability to read and provide informed consent

3. Current patient or therapist at the Center for Anxiety and Related Disorders (CARD)

4. Ability to complete exercise (e.g. no physical injuries)

Exclusion Criteria:

1. Participants considered high risk based on the ACSM risk stratification guidelines (derived from PAR-Q)

2. 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Mood Disorders

Intervention

Behavioral:
• Exercise
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).
• Worry Stone
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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Positive and Negative Affect Schedule - Patient	State Version (PANAS; Watson, Clark, & Tellegen, 1988). The PANAS was developed as a brief measure of affect and yields the factors of Positive Affectivity and Negative Affectivity.	Change throughout 50-minute therapy session.
Secondary	Positive and Negative Affect Schedule - Therapist	State Version (PANAS; Watson, Clark, & Tellegen, 1988). The PANAS was developed as a brief measure of affect and yields the factors of Positive Affectivity and Negative Affectivity.	Change throughout 50-minute therapy session.
Secondary	Affect Grid - Patient	A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness	Change throughout 50-minute therapy session.
Secondary	Affect Grid - Therapist	A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness	Change throughout 50-minute therapy session.
Secondary	Credibility-Expectations Questionnaire - Patient	The CEQ is a 6-item self-report questionnaire, which assesses treatment rationale and expectancy. The scale has been used across a number of treatment trials. This questionnaire will be slightly modified to measure satisfaction with the worry stone and exercise machine conditions and will be administered at the beginning of each visit.	Change throughout 50-minute therapy session.
Secondary	Credibility-Expectations Questionnaire - Therapist	The CEQ is a 6-item self-report questionnaire, which assesses treatment rationale and expectancy. The scale has been used across a number of treatment trials. This questionnaire will be slightly modified to measure satisfaction with the worry stone and exercise machine conditions and will be administered at the beginning of each visit.	Change throughout 50-minute therapy session.
Secondary	Session Rating Scales (Questions 3-7) - Patient	Participants will be asked questions on a 1 to 5 Likert scale related to involvement of the intervention in ability to discuss emotional topics and comfort in using the intervention device.	Change throughout 50-minute therapy session.
Secondary	Session Rating Scales (Questions 3-7) - Therapist	Participants will be asked questions on a 1 to 5 Likert scale related to involvement of the intervention in ability to discuss emotional topics and comfort in using the intervention device.	Change throughout 50-minute therapy session.
Secondary	Qualitative Feedback - Therapist	Therapists will be given the option to write briefly about their thoughts of the impact of the movement strategies on their therapy sessions.	Change throughout 50-minute therapy session.