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Enhancing Therapy Process With Movement Strategies

Primary Purpose

Anxiety Disorders, Mood Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Worry Stone
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1

Group 2

Arm Description

First session: worry stone, second session: exercise peddler

First session: exercise peddler, second session: worry stone

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.
Affect Grid - Patient
A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness
Affect Grid - Therapist
A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness
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.
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.
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.
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.
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.

Full Information

First Posted
October 7, 2016
Last Updated
May 2, 2017
Sponsor
Boston University Charles River Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03140124
Brief Title
Enhancing Therapy Process With Movement Strategies
Official Title
Enhancing Therapy Process With Movement Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Feasibility - unable to recruit therapists to enter the study
Study Start Date
November 3, 2015 (Actual)
Primary Completion Date
March 6, 2017 (Actual)
Study Completion Date
March 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Mood Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants receive both conditions, with randomized order
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
First session: worry stone, second session: exercise peddler
Arm Title
Group 2
Arm Type
Other
Arm Description
First session: exercise peddler, second session: worry stone
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Worry Stone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Session Rating Scale - Patient version (Questions 1 and 2)
Description
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).
Time Frame
Change throughout 50-minute therapy session.
Title
Session Rating Scale - Therapist version (Questions 1 and 2)
Description
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).
Time Frame
Change throughout 50-minute therapy session.
Secondary Outcome Measure Information:
Title
Positive and Negative Affect Schedule - Patient
Description
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.
Time Frame
Change throughout 50-minute therapy session.
Title
Positive and Negative Affect Schedule - Therapist
Description
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.
Time Frame
Change throughout 50-minute therapy session.
Title
Affect Grid - Patient
Description
A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness
Time Frame
Change throughout 50-minute therapy session.
Title
Affect Grid - Therapist
Description
A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness
Time Frame
Change throughout 50-minute therapy session.
Title
Credibility-Expectations Questionnaire - Patient
Description
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.
Time Frame
Change throughout 50-minute therapy session.
Title
Credibility-Expectations Questionnaire - Therapist
Description
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.
Time Frame
Change throughout 50-minute therapy session.
Title
Session Rating Scales (Questions 3-7) - Patient
Description
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.
Time Frame
Change throughout 50-minute therapy session.
Title
Session Rating Scales (Questions 3-7) - Therapist
Description
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.
Time Frame
Change throughout 50-minute therapy session.
Title
Qualitative Feedback - Therapist
Description
Therapists will be given the option to write briefly about their thoughts of the impact of the movement strategies on their therapy sessions.
Time Frame
Change throughout 50-minute therapy session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing Therapy Process With Movement Strategies

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