Enhancing Therapy Process With Movement Strategies

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Terminated
CT.gov ID
NCT03140124
Collaborator
(none)
1
1
2
16.1
0.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
  • Behavioral: Worry Stone
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants receive both conditions, with randomized orderParticipants receive both conditions, with randomized order
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Enhancing Therapy Process With Movement Strategies
Actual Study Start Date :
Nov 3, 2015
Actual Primary Completion Date :
Mar 6, 2017
Actual Study Completion Date :
Mar 6, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Group 1

First session: worry stone, second session: exercise peddler

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).

Behavioral: 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.

Other: Group 2

First session: exercise peddler, second session: worry stone

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).

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  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

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston University Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Boston University Charles River Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Otto, Full Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT03140124
Other Study ID Numbers:
  • 3889
First Posted:
May 4, 2017
Last Update Posted:
May 4, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2017