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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04781608
Other study ID # VELUX 22361
Secondary ID 1779339504-0225/
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2021
Est. completion date June 30, 2022

Study information

Verified date November 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 662
Est. completion date June 30, 2022
Est. primary completion date May 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Sensory Loss (Impairment of Sight and/or Hearing)

Intervention

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.

Locations

Country Name City State
Denmark University of Copenhagen Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Velux Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary WHO-5 well-being 5-item measure of general well-being (Bech, 1999, 2012) Within the last 2 weeks
Primary Couple Satisfaction Index 4-item measure of satisfaction with one's romantic relationship (Funk & Rogge, 2007) Follow-up 1: During the last 6 weeks
Primary Depression 9-item measure of depressive symptoms (PHQ-9; Kroenke, Spitzer, & Williams, 2001; Kroenke
& Spitzer, 2002)
Within the last 2 weeks
Secondary 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
Secondary Communication 12-item measure of satisfaction with communication with partner (Jones, Jones, & Morris, .018) Follow-up 1: During the last 6 weeks