A pilot randomised controlled trial of an Acceptance and Commitment Therapy group intervention for family carers of people with dementia

Not Applicable

Recruiting

• Conditions: Generalized Anxiety; Mixed anxiety and depressive disorder; F41.2

• Registration Number: RBR-10m9tg2r
• Lead Sponsor: niversidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-01
• Study Completion: 2022-12-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Be a family carer of a relative with a clinical diagnosis of dementia; aged 18 and over; identifying oneself as a primary carer in their family; providing a minimum of 28 hours of care each week; having a minimum of four years of formal education; having access to the internet and a device to access online sessions; scoring nine or higher on the Generalised Anxiety Disorder (GAD-7) questionnaire.

Exclusion Criteria

Currently receiving psychological therapy

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety will be assessed using the Generalised Anxiety Disorder Scale-7 (GAD-7) at three time points: baseline (0 weeks), post-intervention (8 weeks post randomisation) and follow-up (20 weeks post randomisation). The hypothesis of the study is that the group intervention will decrease participants level of anxiety.

Secondary Outcome Measures

Name	Time	Method
The following measures will be completed at baseline (0 weeks), post-intervention (8 weeks post randomisation) and follow-up (20 weeks post randomisation): (1) Depression: Patient Health Questionnaire-9 (PHQ-9) and Hospital Anxiety and Depression Scale (HADS-D); (2)Anxiety: Hospital Anxiety and Depression Scale (HADS-A); (3) Carer burden: Zarit Burden Interview Short version; (4) Quality of life: Quality of Life of Alzheimer’s Disease (Qdv-DA); (5) Experiential avoidance: Acceptance and Action Questionnaire-II and Experiential Avoidance in Caregiving Questionnaire.