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

August 19, 2016 updated by: Gerhard Andersson, Linkoeping University
Randomized trial comparing internet-delivered ACT with therapist support against waiting list for persons with hearing loss and comorbid psychological distress

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden
        • Linköpings universitet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-delivered ACT
Guided Internet-delivered Acceptance and commitment therapy for 8 weeks
Behavioral: Internet-delivered ACT
Therapist-guided Internet-delivered ACT (acceptance and commitment therapy) for 8 weeks
No Intervention: Wait list control
No treatment during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Hearing Handicap Inventory for Elderly-Screening, change between pre and post treatment
Time Frame: through study completion, an average of 8 weeks
through study completion, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Health Questionnaire Depression 9 (PHQ9), change between pre and post treatment
Time Frame: through study completion, an average of 8 weeks
through study completion, an average of 8 weeks
Generalized Anxiety Disorder 7 (GAD7), change between pre and post treatment
Time Frame: through study completion, an average of 8 weeks
through study completion, an average of 8 weeks
Quality of Life Inventory (QOLI), change between pre and post treatment
Time Frame: through study completion, an average of 8 weeks
through study completion, an average of 8 weeks
Hearing Acceptance Questionnaire (HAQ), change between pre and post treatment
Time Frame: through study completion, an average of 8 weeks
through study completion, an average of 8 weeks
Hearing Self-Efficacy (HSE), change between pre and post treatment
Time Frame: through study completion, an average of 8 weeks
through study completion, an average of 8 weeks
Perceived Stress Scale-4 (PSS-4), change between pre and post treatment
Time Frame: through study completion, an average of 8 weeks
through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 5, 2014

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAS-IT_2009-0055_ACTHÖR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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