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

Chronic Medical Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408651
• Other study ID #: LIIT
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2022
• Source: University of Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Medical Conditions

Intervention

Behavioral:
• LIIT.CI ACT
4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions
• LIIT.CI CFT
4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions

Locations

Country	Name	City	State
Portugal	Inês Trindade	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
University of Coimbra

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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