Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss

Hearing Loss Clinical Trial

Official title:

Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877329
• Other study ID #: FAS-IT_2009-0055_ACTHÖR
• Status: Completed
• Phase: N/A
• First received: April 5, 2014
• Last updated: August 19, 2016
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2016
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Randomized trial comparing internet-delivered ACT with therapist support against waiting list for persons with hearing loss and comorbid psychological distress

Description:

Hearing loss is the most common sensory disability in the world. Hearing loss is an auditory disability which affects not only speech recognition, but also the ability to recognize, locate and identify sounds in one's environment. Today there are a variety of studies investigating the relationship between hearing loss and mental health. For example, there are studies showing that hearing loss can lead to depression, somatization, social isolation, worrying or anxiety, loneliness, smaller social networks, lower self-efficacy, sensitivity to stress, burnout, and impaired sleep quality and quality of life in comparison with people with normal hearing. Initial results from other studies indicate that acceptance may be of importance, as it in turn can lead to increased help-seeking.To avoid prolonged stress and a healthy self-efficacy could contribute to greater well-being of people with hearing loss. This is the first study to use ACT to improve psychological health in people with hearing loss through the process of psychological flexibility. The treatment is eight weeks long and internet delivered through self-help texts with weekly therapist support.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• HHIE-S score over 8

• Indication of comorbid psychological suffering/distress (defined as total score above 0 on PHQ9/GAD7 or below 1sd on QOLI)

Exclusion Criteria:

• No computer with internet connection

• Unability to understand written content

• Incomplete screening procedure

• A health condition that needs immediate care

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Behavioral:
• Internet-delivered ACT
Therapist-guided Internet-delivered ACT (acceptance and commitment therapy) for 8 weeks

Locations

Country	Name	City	State
Sweden	Linköpings Universitet	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Hearing Handicap Inventory for Elderly-Screening, change between pre and post treatment		through study completion, an average of 8 weeks	No
Secondary	Patient Health Questionnaire Depression 9 (PHQ9), change between pre and post treatment		through study completion, an average of 8 weeks	No
Secondary	Generalized Anxiety Disorder 7 (GAD7), change between pre and post treatment		through study completion, an average of 8 weeks	No
Secondary	Quality of Life Inventory (QOLI), change between pre and post treatment		through study completion, an average of 8 weeks	No
Secondary	Hearing Acceptance Questionnaire (HAQ), change between pre and post treatment		through study completion, an average of 8 weeks	No
Secondary	Hearing Self-Efficacy (HSE), change between pre and post treatment		through study completion, an average of 8 weeks	No
Secondary	Perceived Stress Scale-4 (PSS-4), change between pre and post treatment		through study completion, an average of 8 weeks	No