Sensory Loss (Impairment of Sight and/or Hearing)SoSNCT04781608
In It Together: Using Acceptance and Commitment Therapy to Treat Distress Among Older Adults With Sensory Loss and Their Spouses
A study testing English: In It Together (IIT) in people with Sensory Loss (Impairment of Sight and/or Hearing), run by University of Copenhagen at 1 site in Denmark.
Trial summary
Impairments in hearing and/or vision are common in older age. Having lived one's life as a fully sighted and hearing individual, older adults with sensory loss must come to terms with their declining capacity to interact with others and waning independence. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensory Loss (Impairment of Sight and/or Hearing)
- What is being tested?
- English: In It Together (IIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 662 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Nov 2021to 30 Jun 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 60 years of age or older
- Be able to read and write in Danish
- Be in a romantic relationship of at least 1 year
- Live together with the partner (share housing)
- Feel either one self or one's partner has a sensory loss (hearing and/or sight) that affects day-to-day life. This sensory loss does not need to be confirmed by a health care provider.
Who cannot join
- Less than 60 years of age
- Cannot read or write in Danish
- Not in a romantic relationship
- Relationship length of less than 1 year
- Not living together with the partner (not share housing)
- Currently receiving psychological help (therapy/intervention)
Trial locations and contacts
1 site in 1 country.
About this study
Impairments in hearing and/or vision are common in older age. Having lived one's life as a fully sighted and hearing individual, older adults with sensory loss must come to terms with their declining capacity to interact with others and waning independence. There is ample research evidence showing that sensory loss (i.e., loss of hearing, vision or both) can be a distressful experience for older adults and their spouses, yet little has been done to understand what works in alleviating this distress or develop scalable cost-effective interventions to counter this distress or associated outcomes like depression, anxiety, poor quality of life, and lower relationship quality. In this project, the investigators will design and test an easy-to-administer, online intervention aimed at reducing emotional and marital distress in older adults with sensory loss and their spouses. The goal of the intervention will be to develop acceptance of the sensory loss through a series of Acceptance and Commitment Therapy inspired educational, self-compassion, and therapeutic activities. In prior research, acceptance has been flagged as a promising factor on which to intervene to assist older couples' emotional and marital recovery in the context of sensory loss. Thus, the investigators expect that the intervention should show encouraging results regarding the alleviation of distress in this group and contribute significantly to the psychosocial rehabilitation of older adults with sensory loss and their spouses.
- Being tested
- English: In It Together (IIT)
- Keywords
- Sensory loss, Hearing impairment, Sight impairment, Elderly couples, Age 60 or older, Online, Digital, Intervention, Acceptance and Commitment therapy
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
English: In It Together (IIT)Behavioural
Also called Danish: Sammen on Sansetab (SOS)
Digital intervention program that consists of 4 modules, to be completed 1 week apart. The modules consist of psychoeducation, as well as acceptance and commitment therapy-inspired activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Gains access to the digital intervention program Receives: Behavioral: English: In It Together (IIT) |
| Wait-list- control group | No intervention | Does not gain access to the intervention (until end of study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO-5 well-being
5-item measure of general well-being (Bech, 1999, 2012)
Measured: Within the last 2 weeks
Couple Satisfaction Index
4-item measure of satisfaction with one's romantic relationship (Funk \& Rogge, 2007)
Measured: Follow-up 1: During the last 6 weeks
Depression
9-item measure of depressive symptoms (PHQ-9; Kroenke, Spitzer, \& Williams, 2001; Kroenke
\& Spitzer, 2002)
Measured: Within the last 2 weeks
Secondary outcomes (2)
Psychological flexibility
7-item measure of psychological flexibility (AAC-II; Bond, Hayes, Baer, Carpenter, Guenole, Orcutt, Waltz, \& Zettle, 2011).
Measured: Follow-up 1: During the last 6 weeks
Communication
12-item measure of satisfaction with communication with partner (Jones, Jones, \& Morris, .018)
Measured: Follow-up 1: During the last 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start22 Nov 2021
- Primary completion16 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Loss (Impairment of Sight and/or Hearing)Studies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomized to one of two conditions: 1) Intervention group, which will receive access to the digital intervention program, and 2) Control group, who will not receive immediate acess to the digital intervention program. Intervention group: Participants will be asked to complete survey measures at baseline (prior to access to the 4-module digital intervention program), 6-weeks, 10 weeks, and 18 weeks. Control group: Participants will be asked to complete survey measures at baseline , 6-weeks, and 10 weeks (control group participants gain access to the digital intervention program after completion of the 10-week survey).
- Masking
- None (open label)
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden
- Responsible party
- Principal investigator, Camilla Stine Øverup, University of Copenhagen
- Investigators
- Camilla S Øverup, PhD, Principal investigator, University of CopenhagenGert Martin Hald, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781608
- Sponsor's protocol ID
- VELUX 22361
- Other IDs
- 1779339, 504-0225/20-5000
- Acronym
- SoS
- Status last verified
- Nov 2022
- First submitted
- 18 Jan 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all individual data, along with a data dictionary and analytic code. The data will be anonymized prior to sharing. The materials will be uploaded to a data repository (which as yet to be determined)
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In It Together: Using Acceptance and Commitment Therapy to Treat Distress Among Older Adults With Sensory Loss and Their Spouses
- ClinicalTrials.gov ID
- NCT04781608
- Acronym / sponsor ID
- SoS / VELUX 22361
- Keywords
- Sensory loss, Hearing impairment, Sight impairment, Elderly couples, Age 60 or older, Online, Digital, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Velux Fonden
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- 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.
Impairments in hearing and/or vision are common in older age. Having lived one's life as a fully sighted and hearing individual, older adults with sensory loss must come to terms with their declining capacity to interact with others and waning independence. There is ample research evidence showing that sensory loss (i.e., loss of hearing, vision or both) can be a distressful experience for older adults and their spouses, yet little has been done to understand what works in alleviating this distress or develop scalable cost-effective interventions to counter this distress or associated outcomes like depression, anxiety, poor quality of life, and lower relationship quality. In this project, the investigators will design and test an easy-to-administer, online intervention aimed at reducing emotional and marital distress in older adults with sensory loss and their spouses. The goal of the intervention will be to develop acceptance of the sensory loss through a series of Acceptance and Commitment Therapy inspired educational, self-compassion, and therapeutic activities. In prior research, acceptance has been flagged as a promising factor on which to intervene to assist older couples' emotional and marital recovery in the context of sensory loss. Thus, the investigators expect that the intervention should show encouraging results regarding the alleviation of distress in this group and contribute significantly to the psychosocial rehabilitation of older adults with sensory loss and their spouses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two conditions: 1) Intervention group, which will receive access to the digital intervention program, and 2) Control group, who will not receive immediate acess to the digital intervention program. Intervention group: Participants will be asked to complete survey measures at baseline (prior to access to the 4-module digital intervention program), 6-weeks, 10 weeks, and 18 weeks. Control group: Participants will be asked to complete survey measures at baseline , 6-weeks, and 10 weeks (control group participants gain access to the digital intervention program after completion of the 10-week survey).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: English: In It Together (IIT)Gains access to the digital intervention program |
| Wait-list- control group | No intervention | –Does not gain access to the intervention (until end of study) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 60 years of age or older
- Be able to read and write in Danish
- Be in a romantic relationship of at least 1 year
- Live together with the partner (share housing)
- Feel either one self or one's partner has a sensory loss (hearing and/or sight) that affects day-to-day life. This sensory loss does not need to be confirmed by a health care provider.
Key exclusion criteria (6 listed)
- Less than 60 years of age
- Cannot read or write in Danish
- Not in a romantic relationship
- Relationship length of less than 1 year
- Not living together with the partner (not share housing)
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 |
|---|---|---|
| English: In It Together (IIT)Also: Danish: Sammen on Sansetab (SOS)Digital intervention program that consists of 4 modules, to be completed 1 week apart. The modules consist of psychoeducation, as well as acceptance and commitment therapy-inspired activities. | Behavioural | Intervention group |
Primary outcome
WHO-5 well-being
Time frame: Within the last 2 weeks
5-item measure of general well-being (Bech, 1999, 2012)
Couple Satisfaction Index
Time frame: Follow-up 1: During the last 6 weeks
4-item measure of satisfaction with one's romantic relationship (Funk \& Rogge, 2007)
Depression
Time frame: Within the last 2 weeks
9-item measure of depressive symptoms (PHQ-9; Kroenke, Spitzer, \& Williams, 2001; Kroenke \& Spitzer, 2002)
2 secondary outcomes
Psychological flexibility
Time frame: Follow-up 1: During the last 6 weeks
Communication
Time frame: Follow-up 1: During the last 6 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 4 Nov 2022.
- Individual participant dataSharing planned: Yes. We will share all individual data, along with a data dictionary and analytic code. The data will be anonymized prior to sharing. The materials will be uploaded to a data repository (which as yet to be determined)
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.
Camilla S Øverup, PhD principal investigator
University of Copenhagen
Gert Martin Hald, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing English: In It Together (IIT) in people with Sensory Loss (Impairment of Sight and/or Hearing), run by University of Copenhagen at 1 site in Denmark.
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 5 inclusion and 6 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 4 Nov 2022. 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 Denmark. 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?
WHO-5 well-being (time frame: Within the last 2 weeks). The study lists 3 primary outcomes in all. 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 4 Nov 2022.