Clinical trial NCT03576365: Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
Official title: Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dysphonia
Voice Disorders
Dysphonia
Keywords: Perceived Control
Distress
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-07-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to pilot test a version of the intervention that has been tailored for participants with dysphonia. The study seeks to determine if the adapted intervention: a) increases perceived control over voice-related stressors and b) decreases stress and distress resulting from voice problems. The study will also explore the usability and acceptability of the program. The goal is to help people with voice problems achieve better voice and quality of life outcomes.

Detailed description: In the investigator's voice clinic, a high prevalence of severe distress has been identified. Distress and voice handicap were positively correlated, and perceived control moderated the relationship. Perceived control is associated with less distress in a variety of medical conditions, has an impact beyond that of coping and personality, and can be increased via targeted intervention.

This is a randomized controlled trial. Participants will be randomly assigned to one of the two groups. Both groups involve completing surveys and receiving information online about voice problem.

Participants complete an initial baseline assessment focused on voice function and emotions, including items from the Perceived Control Scale, Voice Handicap Index-10, Perceived Stress Scale, Brief Symptom Inventory-18. Finally, the participants will complete some brief feedback questions about the material.

Next, twice a week for up to three weeks participants will complete check-ins from the online program. Participants in the intervention arm will complete self-guided exercises and brief assessment questions. Participants in the information-only arm will complete mini knowledge quizzes.

All participants will complete brief a post-intervention assessment parallel to the baseline assessment. Lastly, they will have an opportunity to provide final feedback on their experience.

Follow-up with each participant will occur one and three months after finishing the program. Questionnaires will be sent via email including Voice Handicap Index-10, Present Perceived Control-8, and questions regarding treatment adherence and voice outcomes.

Eligibility criteria: Inclusion Criteria:

1. Patients who are seen at the Otolaryngology Clinic (University of Minnesota Health Clinics and Surgery Center, or Fairview Hospital Maple Grove or Southdale) with Muscle Tension Dysphonia
2. Patients between 18-80 years of age experiencing a voice problem
3. Scored high (\>10) on the Voice Handicap Index (VHI-10)
4. Has the ability to complete informed consent process
5. Interested in using an online program/intervention
6. Has reliable access to internet

Exclusion Criteria:

1. Patients who have clinical need for concurrent treatment will be excluded to decrease confounding introduced by having multiple simultaneous interventions. This may include:

   1. Concurrent laryngeal lesion requiring immediate operative or other intervention
   2. Concurrent participation in speech therapy
   3. Concurrent need for new medications that may directly affect voice-related symptoms
2. Participant has a Speech Language Pathology visit scheduled in two weeks or less from when they will start the program (if applicable)
3. Unable to read English (as determined by their ability to complete the clinic intake forms)
4. Female and pregnant
5. Prisoner
6. Unable to provide informed consent (e.g., patients with dementia)

Primary outcomes:
measure: Perceived Control
timeFrame: 2 weeks
Secondary outcomes:
measure: Voice Handicap
timeFrame: 2 weeks
measure: Perceived Stress
timeFrame: 2 Weeks
measure: Psychological Symptoms
timeFrame: 2 weeks
Other outcomes:
measure: Intervention Module Acceptability
timeFrame: Baseline and at 2 weeks
measure: Patients' Adherence to Voice Therapy and Treatment
timeFrame: 2 weeks to 2 years
Locations:
city: Maple Grove
country: United States
facility: University of Minnesota Health Maple Grove Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Health Clinics and Surgeries Otolaryngology Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Stephanie Misono, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009.
citation: Frazier P, Keenan N, Anders S, Perera S, Shallcross S, Hintz S. Perceived past, present, and future control and adjustment to stressful life events. J Pers Soc Psychol. 2011 Apr;100(4):749-765. doi: 10.1037/a0022405.
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Derogatis LR. BSI 18 (Brief Symptom Inventory 18): Administration, Scoring, and Procedures Manual. Bloomington, MN: NCS Pearson; 2000