Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
Phase: NA
Conditions: Chronic Kidney Diseases, Depression
Sponsor: Universidad Europea de Madrid

 
 
 
 
 
 
 
Effects of an ACT-based Psychological Treatment in Patients with 
Chronic Kidney Disease 
ID: EC040-23_FJD-FRIAT 
Document date: July 8, 2023 
IP: Francisco Montesinos, Ph.D. 
Study Protocol and Statistical Analysis Plan  
 
 
 

Study Protocol:  
• Objective: To study the effectiveness of an intervention based on 
Acceptance and Commitment Therapy (ACT), applied in CKD 
patients with high levels of depressive symptomatology. 
• Design: randomized clinical trial 
• Methods:  
After being informed about the study, all CKD patients giving 
written informed consent will be assessed to determine eligibility for 
study entry. Patients who meet eligibility requirements will be 
assessed through a structured interview and standardized 
questionnaires and randomly assigned to two conditions, intervention 
group and control group (waiting list).  
Participants assigned intervention group will immediately receive 
psychological intervention consisting in an 8-session individual face 
to-face ACT-based treatment. The participants will be assessed 
through self-report instruments before and after treatment and at 3 
months follow-up. 
Patients assigned to control group condition will remain on the 
waiting list and will receive the intervention after 5 months. 
• Intervention protocol 
Session 1: Introducing therapy, establishing the therapeutic alliance, 
reframing the problem. Introducing values clarification. Therapeutic 
methods. Therapeutic methods: metaphor of the two climbers, 
functional analysis. 
Session 2: Values clarification, commitment to action. Therapeutic 
methods: garden metaphor, funeral exercise. 
Session 3: Discriminating control as a problem, introducing 
acceptance, commitment to action. Therapeutic methods: metaphor 
of contemplating the waves from the beach, introduction to defusion 
training. 
Session 4: Awareness of body sensations, exposure to  anxiety, 
depressive mood and other emotional barriers. Therapeutic methods: 
Defusion training (body scan, emotional monitoring, valuable actions 
in presence of emotion/physical sensations). 

Session 5. Learning to observe thoughts as thoughts. Acceptance. 
Therapeutic methods: leaves on a stream exercise, mindfulness. 
Session 6. Acceptance as choice. Therapeutic methods: defusion 
training, invitation to choose acting in the presence of emotions, 
thoughts or physical sensations. 
Session 7. Establishing the perspective of the "self as a context". 
Therapeutic methods: exercise of the three circles of the self, 
chessboard metaphor. 
Session 8. Relapse prevention. Therapeutic methods: metaphor of 
falling off the bike, mindfulness. 
 
Statistical Analysis Plan (SAP):  
The results will be analysed through non-parametric techniques 
(comparisons of pre, post and follow-up group means). An analysis of 
variance will be performed to determine the specific weight of each 
independent variable, as well as the possible interaction between them. The 
statistical approach of Jacobson and Truax (1991) will be used to estimate 
the clinical significance of the effect.