Anxiety DisordersNCT03140124
Enhancing Therapy Process With Movement Strategies
A study testing Exercise and Worry Stone in people with Anxiety Disorders and Mood Disorders, run by Boston University Charles River Campus at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Mood Disorders
- What is being tested?
- Exercise and Worry Stone
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2015to 6 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety Disorders, Mood Disorders
- Being tested
- Exercise, Worry Stone
- Medical subject headings
- Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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 StoneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | First session: worry stone, second session: exercise peddler Receives: Behavioral: Exercise; Behavioral: Worry Stone |
| Group 2 | Other | First session: exercise peddler, second session: worry stone Receives: Behavioral: Exercise; Behavioral: Worry Stone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Change throughout 50-minute therapy session.
Secondary outcomes (9)
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.
Measured: Change throughout 50-minute therapy session.
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.
Measured: Change throughout 50-minute therapy session.
Affect Grid - Patient
A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness
Measured: Change throughout 50-minute therapy session.
Affect Grid - Therapist
A single item scale used to quickly assess affect along the dimensions of pleasure-displeasure and arousal-sleepiness
Measured: Change throughout 50-minute therapy session.
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.
Measured: Change throughout 50-minute therapy session.
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.
Measured: Change throughout 50-minute therapy session.
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.
Measured: Change throughout 50-minute therapy session.
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.
Measured: Change throughout 50-minute therapy session.
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.
Measured: Change throughout 50-minute therapy session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start3 Nov 2015
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
Why it stopped: Feasibility - unable to recruit therapists to enter the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants receive both conditions, with randomized order
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Otto, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140124
- Sponsor's protocol ID
- 3889
- Status last verified
- May 2017
- First submitted
- 7 Oct 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Therapy Process With Movement Strategies
- ClinicalTrials.gov ID
- NCT03140124
- Acronym / sponsor ID
- 3889
- Conditions
- Anxiety Disorders, Mood Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility - unable to recruit therapists to enter the study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 3 Nov 2015 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants receive both conditions, with randomized order
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Behavioral: Exercise, Behavioral: Worry StoneFirst session: worry stone, second session: exercise peddler |
| Group 2 | Other | Behavioral: Exercise, Behavioral: Worry StoneFirst session: exercise peddler, second session: worry stone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseEach 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). | Behavioural | Group 1, Group 2 |
| Worry StoneFor 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. | Behavioural | Group 1, Group 2 |
Primary outcome
Session Rating Scale - Patient version (Questions 1 and 2)
Time frame: 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)
Time frame: 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).
9 secondary outcomes
Positive and Negative Affect Schedule - Patient
Time frame: Change throughout 50-minute therapy session.
Positive and Negative Affect Schedule - Therapist
Time frame: Change throughout 50-minute therapy session.
Affect Grid - Patient
Time frame: Change throughout 50-minute therapy session.
Affect Grid - Therapist
Time frame: Change throughout 50-minute therapy session.
Credibility-Expectations Questionnaire - Patient
Time frame: Change throughout 50-minute therapy session.
Credibility-Expectations Questionnaire - Therapist
Time frame: Change throughout 50-minute therapy session.
Session Rating Scales (Questions 3-7) - Patient
Time frame: Change throughout 50-minute therapy session.
Session Rating Scales (Questions 3-7) - Therapist
Time frame: Change throughout 50-minute therapy session.
Qualitative Feedback - Therapist
Time frame: Change throughout 50-minute therapy session.
Results and safety
The study was stopped early (reason given: Feasibility - unable to recruit therapists to enter the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Worry Stone in people with Anxiety Disorders and Mood Disorders, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Feasibility - unable to recruit therapists to enter the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session Rating Scale - Patient version (Questions 1 and 2) (time frame: Change throughout 50-minute therapy session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.