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

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ClinicalTrials.gov Identifier: NCT02877329
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University

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

Condition or disease Intervention/treatment Phase
Hearing Loss Behavioral: Internet-delivered ACT Not Applicable

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  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. The Hearing Handicap Inventory for Elderly-Screening, change between pre and post treatment [ Time Frame: through study completion, an average of 8 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877329


Locations
Sweden
Linköpings Universitet
Linköping, Sweden
Sponsors and Collaborators
Linkoeping University

Responsible Party: Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT02877329     History of Changes
Other Study ID Numbers: FAS-IT_2009-0055_ACTHÖR
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gerhard Andersson, Linkoeping University:
psychological effects

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms