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In It Together: Using Acceptance and Commitment Therapy to Treat Distress Among Older Adults With Sensory Loss and Their Spouses (SoS)

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ClinicalTrials.gov Identifier: NCT04781608
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : June 18, 2021
Sponsor:
Collaborator:
Velux Fonden
Information provided by (Responsible Party):
Camilla Stine Øverup, University of Copenhagen

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sensory Loss (Impairment of Sight and/or Hearing) Behavioral: English: In It Together (IIT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: In It Together: Using Acceptance and Commitment Therapy to Treat Distress Among Older Adults With Sensory Loss and Their Spouses
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Gains access to the digital intervention program
 Behavioral: English: In It Together (IIT)
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.
Other Name: Danish: Sammen on Sansetab (SOS)
No Intervention: Wait-list- control group
Does not gain access to the intervention (until end of study)


Outcome Measures
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Primary Outcome Measures :
  1. WHO-5 well-being [ Time Frame: Within the last 2 weeks ]
    5-item measure of general well-being (Bech, 1999, 2012)

  2. 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)

  3. Depression [ Time Frame: Within the last 2 weeks ]

    9-item measure of depressive symptoms (PHQ-9; Kroenke, Spitzer, & Williams, 2001; Kroenke

    & Spitzer, 2002)



Secondary Outcome Measures :
  1. Psychological flexibility [ Time Frame: Follow-up 1: During the last 6 weeks ]
    7-item measure of psychological flexibility (AAC-II; Bond, Hayes, Baer, Carpenter, Guenole, Orcutt, Waltz, & Zettle, 2011).

  2. Communication [ Time Frame: Follow-up 1: During the last 6 weeks ]
    12-item measure of satisfaction with communication with partner (Jones, Jones, & Morris, .018)


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781608


Contacts
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Contact: Camilla S Øverup, PhD +45 35 33 51 74 camilla.oeverup@sund.ku.dk
Contact: Gert Martin Hald, PhD +45 35 33 72 13 ghald@sund.ku.dk

Locations
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Denmark
University of Copenhagen Recruiting
Copenhagen, Denmark, 1014
Contact: Camilla S Øverup, PhD    +45 35 33 51 74    camilla.oeverup@sund.ku.dk   
Contact: Gert Martin Hald, PhD    +45 35 33 72 13    ghald@sund.ku.dk   
Sub-Investigator: Christine M Lehane, PhD         
Sub-Investigator: Jesper Dammeyer, PhD         
Sub-Investigator: Walter Wittich, PhD         
Sponsors and Collaborators
University of Copenhagen
Velux Fonden
Investigators
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Principal Investigator: Camilla S Øverup, PhD University of Copenhagen
Principal Investigator: Gert Martin Hald, PhD University of Copenhagen
More Information
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Responsible Party: Camilla Stine Øverup, Postdoc, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04781608    
Other Study ID Numbers: VELUX 22361
1779339 ( Other Identifier: Danish Data Protections Agency )
504-0225/20-5000 ( Other Identifier: University of Copenhagen Research Ethics Committee for Science and Health )
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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)
Supporting Materials: Study Protocol
Analytic Code
Time Frame: The data will be shared after June 30th, 2022.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camilla Stine Øverup, University of Copenhagen:
Sensory loss
Hearing impairment
Sight impairment
Elderly couples
Age 60 or older
 Online
Digital
Intervention
Acceptance and Commitment therapy