Hearing LossNCT02877329
Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss
A study testing Internet-delivered ACT in people with Hearing Loss, run by Linkoeping University at 1 site in Sweden.
Trial summary
Randomized trial comparing internet-delivered ACT with therapist support against waiting list for persons with hearing loss and comorbid psychological distress Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Internet-delivered ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- No computer with internet connection
- Unability to understand written content
- Incomplete screening procedure
- A health condition that needs immediate care
Trial locations and contacts
1 site in 1 country.
About this study
Randomized trial comparing internet-delivered ACT with therapist support against waiting list for persons with hearing loss and comorbid psychological distress
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Internet-delivered ACT
- Keywords
- psychological effects
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered ACTBehavioural
Therapist-guided Internet-delivered ACT (acceptance and commitment therapy) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered ACT | Experimental | Guided Internet-delivered Acceptance and commitment therapy for 8 weeks Receives: Behavioral: Internet-delivered ACT |
| Wait list control | No intervention | No treatment during 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hearing Handicap Inventory for Elderly-Screening, change between pre and post treatment
Measured: through study completion, an average of 8 weeks
Secondary outcomes (6)
Patient Health Questionnaire Depression 9 (PHQ9), change between pre and post treatment
Measured: through study completion, an average of 8 weeks
Generalized Anxiety Disorder 7 (GAD7), change between pre and post treatment
Measured: through study completion, an average of 8 weeks
Quality of Life Inventory (QOLI), change between pre and post treatment
Measured: through study completion, an average of 8 weeks
Hearing Acceptance Questionnaire (HAQ), change between pre and post treatment
Measured: through study completion, an average of 8 weeks
Hearing Self-Efficacy (HSE), change between pre and post treatment
Measured: through study completion, an average of 8 weeks
Perceived Stress Scale-4 (PSS-4), change between pre and post treatment
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877329
- Sponsor's protocol ID
- FAS-IT_2009-0055_ACTHÖR
- Status last verified
- Aug 2016
- First submitted
- 5 Apr 2014
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss
- ClinicalTrials.gov ID
- NCT02877329
- Acronym / sponsor ID
- FAS-IT_2009-0055_ACTHÖR
- Conditions
- Hearing Loss
- Keywords
- psychological effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered ACT | Experimental | Behavioral: Internet-delivered ACTGuided Internet-delivered Acceptance and commitment therapy for 8 weeks |
| Wait list control | No intervention | –No treatment during 8 weeks |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- No computer with internet connection
- Unability to understand written content
- Incomplete screening procedure
- A health condition that needs immediate care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered ACTTherapist-guided Internet-delivered ACT (acceptance and commitment therapy) for 8 weeks | Behavioural | Internet-delivered ACT |
Primary outcome
The Hearing Handicap Inventory for Elderly-Screening, change between pre and post treatment
Time frame: through study completion, an average of 8 weeks
6 secondary outcomes
Patient Health Questionnaire Depression 9 (PHQ9), change between pre and post treatment
Time frame: 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
Quality of Life Inventory (QOLI), change between pre and post treatment
Time frame: 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
Hearing Self-Efficacy (HSE), change between pre and post treatment
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Individual participant dataSharing planned: No
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Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered ACT in people with Hearing Loss, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hearing Handicap Inventory for Elderly-Screening, change between pre and post treatment (time frame: through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.