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

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 Overview

• Status: Completed
• Conditions: Sensory Loss (Impairment of Sight and/or Hearing)
• Intervention / Treatment: Behavioral: English: In It Together (IIT)

• Study Type: Interventional
• Enrollment (Actual): 662
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 1014
    • University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Danish: Sammen on Sansetab (SOS)
No Intervention: Wait-list- control group; Does not gain access to the intervention (until end of study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHO-5 well-being	5-item measure of general well-being (Bech, 1999, 2012)	Within the last 2 weeks
Couple Satisfaction Index	4-item measure of satisfaction with one's romantic relationship (Funk & Rogge, 2007)	Follow-up 1: During the last 6 weeks
Depression	9-item measure of depressive symptoms (PHQ-9; Kroenke, Spitzer, & Williams, 2001; Kroenke & Spitzer, 2002)	Within the last 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological flexibility	7-item measure of psychological flexibility (AAC-II; Bond, Hayes, Baer, Carpenter, Guenole, Orcutt, Waltz, & Zettle, 2011).	Follow-up 1: During the last 6 weeks
Communication	12-item measure of satisfaction with communication with partner (Jones, Jones, & Morris, .018)	Follow-up 1: During the last 6 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Velux Fonden
• Investigators: Principal Investigator: Camilla S Øverup, PhD, University of Copenhagen; Principal Investigator: Gert Martin Hald, PhD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Intervention; Online; Hearing impairment; Digital; Sensory loss; Sight impairment; Elderly couples; Age 60 or older; Acceptance and Commitment therapy
• 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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)
• IPD Sharing Time Frame: The data will be shared after June 30th, 2022.
• IPD Sharing Supporting Information Type: Study Protocol; Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No