Exercise, Mood and Stress Study

NCT02887027 | Completed Phase 1

• 1 other identifier: 4017
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multiple studies indicate that exercise is effective in treating depressed mood and reducing anxiety sensitivity. As depressive symptoms and anxiety sensitivity are elevated in individuals with anxiety and depressive disorders, exercise could help reduce these symptoms and aid in the overall treatment of these disorders. This project aims to test an ecological momentary exercise intervention (Exercise4Mood) delivered via a mobile phone application in individuals with anxiety or depressive disorders. Previous protocols have tested the acceptability and usability of Exercise4Mood in healthy participants. In Phase 1 of the study, focus groups were conducted to explore the acceptability and usability of the Exercise4Mood app. Qualitative feedback was collected and modifications were made to the app based on this feedback. In Phase 2 of the study, the Exercise4Mood app was tested in 6 healthy participants. Preliminary unpublished findings indicate that the app was acceptable and promoted increased physical activity. The aim of this protocol is to test the acceptability, usability, and efficacy (to improve mood and reduce anxiety) of Exercise4Mood in patients with anxiety or depressive disorders.

Conditions

Anxiety; Post-Traumatic Stress Disorder; Depression

Outcome Measures

Primary Outcomes (4)

• Credibility-Expectations Questionnaire (CEQ)

  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.

  Day 29

• Client Satisfaction Questionnaire (CSQ-8)

  The CSQ-8 is an 8-item, easily scored and administered measurement that is designed to measure client satisfaction with services. The CSQ-8 is a valid, efficient, and sensitive measure of client satisfaction and has been used across populations and mental health services (Attkisson et al, 1994; Attkisson \& Zwick, 1982).

  Day 29

• 7-Day Physical Activity Recall (PAR)

  The is an interviewer-administered procedure assessment of physical activity. Validity and reliability of this technique have been demonstrated (Blair et al., 1985; Sallis et al., 1998) and it has been used in numerous studies. This instrument has been shown to be sensitive to change in studies of moderate intensity activity (Dunn et al., 1998; Dunn et al., 1999).

  Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days

• Physical Activity measured in METS (assessed via Actigraphy)

  Participants will be lent an ActiGraph (ActiSleep-BT model) wireless activity monitor and Polar heart rate monitor (Polar FT) to wear during the baseline and intervention period. The actigraph is a compact and lightweight device that is worn on an adjustable elastic strap around the waist in conjunction with the heart rate monitor strap that fits securely around the participant's chest area. Participants will be asked to wear the activity monitor during all waking hours and the heart rate monitor only when they are exercising. They will return these devices at the Endpoint Visit.

  Change from the start of the baseline period, an expected average of 11 days assessed daily through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days

Secondary Outcomes (4)

• Anxiety Sensitivity Index (ASI)

  Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days

• Center for Epidemiological Studies-Depression (CES-D)

  Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days

• PTSD Checklist for DSM 5 (PCL) - for individuals with PTSD diagnosis only

  Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days

• Depression Anxiety Stress Scale 21 (DASS 21)

  Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days

Study Arms (3)

Exercise Group 1

EXPERIMENTAL

Participants assigned to this group will complete a baseline period of 8 days and an Exercise4Mood Intervention period of 21 days.

Behavioral: Exercise4Mood Intervention

Exercise Group 2

EXPERIMENTAL

Participants assigned to this group will complete a baseline period of 11 days and an Exercise4Mood Intervention period of 18 days.

Behavioral: Exercise4Mood Intervention

Exercise Group 3

EXPERIMENTAL

Participants assigned to this group will complete a baseline period of 15 days and an Exercise4Mood Intervention period of 14 days.

Behavioral: Exercise4Mood Intervention

Interventions

Exercise4Mood Intervention BEHAVIORAL

The Exercise4Mood Intervention was designed based on principles from the Exercise for Mood and Anxiety protocol (Smits et al., 2009) and consists primarily of a mobile application called Exercise4Mood. It will be supported by text-messages, delivered through SymTrend, reminding participants about their scheduled exercise sessions and prompting them to engage with the app. Its core features include: motivational tips to encourage exercise, reminders about scheduled exercise, tracking of exercise behavior, tracking of mood before, during, and after exercise, and post-exercise positive reinforcement statements.

Exercise Group 1; Exercise Group 2; Exercise Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18 to 65.
• Ability to read and provide informed consent
• Ownership of an iPhone smartphone device
• Sedentary as defined as not participating in at least 90 minutes of moderate-intensity exercise per week for at least 3 months.
• At least minimally active as defined as participating in an average of 10 minutes of mild-intensity physical activity (e.g. walking) per day for the past two weeks.
• Interest in increasing exercise
• Daily access to the Internet
• Current DSM 5 diagnosis of an Anxiety Disorder, Depressive Disorder (i.e. Major Depressive Disorder or Persistent Depressive Disorder), or Post-Traumatic Stress Disorder (PTSD)
• Sufficient command of the English language

You may not qualify if:

• Participants considered high risk based on the American College Sports Medicine risk stratification guidelines.
• Participants meeting DSM-5 criteria for a Substance-Related Disorder in the last three months (other than caffeine or nicotine dependence)
• Participants meeting DSM-5 criteria for past or present Bipolar I or II Disorder or Schizophrenia Spectrum or Other Psychotic Disorder
• Participants meeting DSM-5 criteria for past or present Eating Disorder
• Participants endorsing active suicidality, homicidality, or self-destructive acts or urges as assessed through the phone screen and the ADIS
• Individuals who are not stable (i.e., at the same dosage for at least the past 4 weeks) on psychotropic medications. Current engagement in psychotherapy is permitted.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Clara Mayo Fellowship: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• Maria Alexandra Kredlow, M.A.

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: August 7, 2016
• First Posted: September 1, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 14, 2017

Record last verified: 2017-07