Enhancing Therapy Process With Movement Strategies

Not Applicable

Terminated

• Conditions: Anxiety Disorders; Mood Disorders
• Interventions: Behavioral: Exercise; Behavioral: Worry Stone

• Registration Number: NCT03140124
• Lead Sponsor: Boston University Charles River Campus

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.

Detailed 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.

Study Timeline

• Study Start: 2015-11-03
• Study First Submitted: 2016-10-07
• Primary Completion: 2017-03-06
• Study Completion: 2017-03-06
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-02
• Last Update Submitted: 2017-05-02
• Study First Posted: 2017-05-04
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Exercise	First session: worry stone, second session: exercise peddler
Group 1	Worry Stone	First session: worry stone, second session: exercise peddler
Group 2	Worry Stone	First session: exercise peddler, second session: worry stone
Group 2	Exercise	First session: exercise peddler, second session: worry stone

Primary Outcome Measures

Name	Time	Method
Session Rating Scale - Patient version (Questions 1 and 2)	Change throughout 50-minute therapy session.	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).
Session Rating Scale - Therapist version (Questions 1 and 2)	Change throughout 50-minute therapy session.	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).

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Affect Schedule - Therapist	Change throughout 50-minute therapy session.	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.
Positive and Negative Affect Schedule - Patient	Change throughout 50-minute therapy session.	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.
Affect Grid - Patient	Change throughout 50-minute therapy session.	A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness
Credibility-Expectations Questionnaire - Therapist	Change throughout 50-minute therapy session.	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.
Session Rating Scales (Questions 3-7) - Patient	Change throughout 50-minute therapy session.	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.
Session Rating Scales (Questions 3-7) - Therapist	Change throughout 50-minute therapy session.	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.
Qualitative Feedback - Therapist	Change throughout 50-minute therapy session.	Therapists will be given the option to write briefly about their thoughts of the impact of the movement strategies on their therapy sessions.
Affect Grid - Therapist	Change throughout 50-minute therapy session.	A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness
Credibility-Expectations Questionnaire - Patient	Change throughout 50-minute therapy session.	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.

Trial Locations

Locations (1)

Boston University; 🇺🇸 Boston, Massachusetts, United States