Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)

Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI): Testing the Efficacy of ACT and CFT Interventions

Chronic illness (CI) presents a significant and negative effect on quality of life and mental health. Further, emotion regulation has been considered of particular importance on the determination of chronic patients' well-being. Evidence suggests that Acceptance and Commitment Therapy (ACT) is an effective approach to improve psychological health in patients with CI. Further, there is some, although limited, evidence, that self-compassion training may be also useful in this context, and the inclusion of self-compassion elements in ACT interventions has even been the focus of attention by recent studies. Nevertheless, no study yet has compared the efficacy of these two types of intervention in CI. This is the aim of the present project - to analyse, in a low intensity eHealth intervention context, whether ACT or Compassion Focused Therapy (CFT) present superiority over the other in improving mental health and illness-related outcomes in CI.

Study Overview

• Status: Completed
• Conditions: Chronic Medical Conditions
• Intervention / Treatment: Behavioral: LIIT.CI ACT; Behavioral: LIIT.CI CFT

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-115
    • Inês Trindade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 65
• Previous diagnosis of a physical chronic medical condition
• Easy access to internet and to a computer

Exclusion Criteria:

• Receiving psychological intervention
• Diagnosis of a severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy	Behavioral: LIIT.CI ACT; 4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions
Experimental: Compassion-Focused Therapy	Behavioral: LIIT.CI CFT; 4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)	Higher scores indicate more depression and anxiety symptoms (0-21)	Changes in results from: immediately pre-intervention and immediately post-intervention assessments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illness shame (Chronic Illness Shame Scale; CISS)	Higher scores indicate higher levels of illness shame (0-28)	Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)	Higher scores indicate higher levels of psychological flexibility (0-108)	Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Self-compassion (Self-compassion scale; SCS)	Higher scores indicate higher levels of self-compassion (subscale of the Self-compassion scale) (13-65)	Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Self-criticism (Self-compassion scale; SCS)	Higher scores indicate higher levels of self-cristicism (subscale of the Self-compassion scale) (13-65)	Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Cognitive fusion (Cognitive Fusion Scale; CFQ-7)	Higher scores indicate higher levels of cognitive fusion (0-28)	Changes in results from: immediately pre-intervention and immediately post-intervention assessments

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of contracting COVID-19 (Fear of contracting COVID-19 scale; FCCS)	Higher scores indicate more fear of contracting COVID-19 (9-45)	Changes in results from: immediately pre-intervention and immediately post-intervention assessments

Collaborators and Investigators

• Sponsor: University of Coimbra

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: LIIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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