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Completed

NCT Number: NCT02877329

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

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

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköpings Universitet

Linköping, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-delivered ACT

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 24, 2016
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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