In It Together: Using Acceptance and Commitment Therapy to Treat Distress Among Older Adults With Sensory Loss and Their Spouses (SoS)
3. november 2022 opdateret af: Camilla Stine Øverup, University of Copenhagen
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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
662
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Copenhagen, Danmark, 1014
- University of Copenhagen
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intervention group
Gains access to the digital intervention program
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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.
Andre navne:
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Ingen indgriben: Wait-list- control group
Does not gain access to the intervention (until end of study)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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WHO-5 well-being
Tidsramme: Within the last 2 weeks
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5-item measure of general well-being (Bech, 1999, 2012)
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Within the last 2 weeks
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Couple Satisfaction Index
Tidsramme: Follow-up 1: During the last 6 weeks
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4-item measure of satisfaction with one's romantic relationship (Funk & Rogge, 2007)
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Follow-up 1: During the last 6 weeks
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Depression
Tidsramme: Within the last 2 weeks
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9-item measure of depressive symptoms (PHQ-9; Kroenke, Spitzer, & Williams, 2001; Kroenke & Spitzer, 2002) |
Within the last 2 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Psychological flexibility
Tidsramme: Follow-up 1: During the last 6 weeks
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7-item measure of psychological flexibility (AAC-II; Bond, Hayes, Baer, Carpenter, Guenole, Orcutt, Waltz, & Zettle, 2011).
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Follow-up 1: During the last 6 weeks
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Communication
Tidsramme: Follow-up 1: During the last 6 weeks
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12-item measure of satisfaction with communication with partner (Jones, Jones, & Morris, .018)
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Follow-up 1: During the last 6 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Camilla S Øverup, PhD, University of Copenhagen
- Ledende efterforsker: Gert Martin Hald, PhD, University of Copenhagen
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. november 2021
Primær færdiggørelse (Faktiske)
16. maj 2022
Studieafslutning (Faktiske)
30. juni 2022
Datoer for studieregistrering
Først indsendt
18. januar 2021
Først indsendt, der opfyldte QC-kriterier
1. marts 2021
Først opslået (Faktiske)
4. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2022
Sidst verificeret
1. november 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- VELUX 22361
- 1779339 (Anden identifikator: Danish Data Protections Agency)
- 504-0225/20-5000 (Anden identifikator: University of Copenhagen Research Ethics Committee for Science and Health)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
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-delingstidsramme
The data will be shared after June 30th, 2022.
IPD-deling Understøttende informationstype
- Studieprotokol
- Analytisk kode
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .