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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered ACT
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring psychological effects

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Linköpings Universitet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-delivered ACT

Wait list control

Arm Description

Guided Internet-delivered Acceptance and commitment therapy for 8 weeks

No treatment during 8 weeks

Outcomes

Primary Outcome Measures

The Hearing Handicap Inventory for Elderly-Screening, change between pre and post treatment

Secondary Outcome Measures

Patient Health Questionnaire Depression 9 (PHQ9), change between pre and post treatment
Generalized Anxiety Disorder 7 (GAD7), change between pre and post treatment
Quality of Life Inventory (QOLI), change between pre and post treatment
Hearing Acceptance Questionnaire (HAQ), change between pre and post treatment
Hearing Self-Efficacy (HSE), change between pre and post treatment
Perceived Stress Scale-4 (PSS-4), change between pre and post treatment

Full Information

First Posted
April 5, 2014
Last Updated
August 19, 2016
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT02877329
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
psychological effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered ACT
Arm Type
Experimental
Arm Description
Guided Internet-delivered Acceptance and commitment therapy for 8 weeks
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
No treatment during 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered ACT
Intervention Description
Therapist-guided Internet-delivered ACT (acceptance and commitment therapy) for 8 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Patient Health Questionnaire Depression 9 (PHQ9), change between pre and post treatment
Time Frame
through study completion, an average of 8 weeks
Title
Generalized Anxiety Disorder 7 (GAD7), change between pre and post treatment
Time Frame
through study completion, an average of 8 weeks
Title
Quality of Life Inventory (QOLI), change between pre and post treatment
Time Frame
through study completion, an average of 8 weeks
Title
Hearing Acceptance Questionnaire (HAQ), change between pre and post treatment
Time Frame
through study completion, an average of 8 weeks
Title
Hearing Self-Efficacy (HSE), change between pre and post treatment
Time Frame
through study completion, an average of 8 weeks
Title
Perceived Stress Scale-4 (PSS-4), change between pre and post treatment
Time Frame
through study completion, an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Linköpings Universitet
City
Linköping
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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