Clinical trial NCT02877329: Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss
Official title: Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: psychological effects
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2016-08-24
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: The Hearing Handicap Inventory for Elderly-Screening, change between pre and post treatment
timeFrame: through study completion, an average of 8 weeks
Secondary outcomes:
measure: Patient Health Questionnaire Depression 9 (PHQ9), change between pre and post treatment
timeFrame: through study completion, an average of 8 weeks
measure: Generalized Anxiety Disorder 7 (GAD7), change between pre and post treatment
timeFrame: through study completion, an average of 8 weeks
measure: Quality of Life Inventory (QOLI), change between pre and post treatment
timeFrame: through study completion, an average of 8 weeks
measure: Hearing Acceptance Questionnaire (HAQ), change between pre and post treatment
timeFrame: through study completion, an average of 8 weeks
measure: Hearing Self-Efficacy (HSE), change between pre and post treatment
timeFrame: through study completion, an average of 8 weeks
measure: Perceived Stress Scale-4 (PSS-4), change between pre and post treatment
timeFrame: through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköpings Universitet
Study officials:
References: