Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)
Primary Purpose
Chronic Medical Conditions
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
LIIT.CI ACT
LIIT.CI CFT
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Medical Conditions
Eligibility Criteria
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.
Sites / Locations
- Inês Trindade
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acceptance and Commitment Therapy
Compassion-Focused Therapy
Arm Description
Outcomes
Primary Outcome Measures
Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)
Higher scores indicate more depression and anxiety symptoms (0-21)
Secondary Outcome Measures
Illness shame (Chronic Illness Shame Scale; CISS)
Higher scores indicate higher levels of illness shame (0-28)
Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)
Higher scores indicate higher levels of psychological flexibility (0-108)
Self-compassion (Self-compassion scale; SCS)
Higher scores indicate higher levels of self-compassion (subscale of the Self-compassion scale) (13-65)
Self-criticism (Self-compassion scale; SCS)
Higher scores indicate higher levels of self-cristicism (subscale of the Self-compassion scale) (13-65)
Cognitive fusion (Cognitive Fusion Scale; CFQ-7)
Higher scores indicate higher levels of cognitive fusion (0-28)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04408651
Brief Title
Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)
Official Title
Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI): Testing the Efficacy of ACT and CFT Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Medical Conditions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Title
Compassion-Focused Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
LIIT.CI ACT
Intervention Description
4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions
Intervention Type
Behavioral
Intervention Name(s)
LIIT.CI CFT
Intervention Description
4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions
Primary Outcome Measure Information:
Title
Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)
Description
Higher scores indicate more depression and anxiety symptoms (0-21)
Time Frame
Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Secondary Outcome Measure Information:
Title
Illness shame (Chronic Illness Shame Scale; CISS)
Description
Higher scores indicate higher levels of illness shame (0-28)
Time Frame
Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Title
Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)
Description
Higher scores indicate higher levels of psychological flexibility (0-108)
Time Frame
Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Title
Self-compassion (Self-compassion scale; SCS)
Description
Higher scores indicate higher levels of self-compassion (subscale of the Self-compassion scale) (13-65)
Time Frame
Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Title
Self-criticism (Self-compassion scale; SCS)
Description
Higher scores indicate higher levels of self-cristicism (subscale of the Self-compassion scale) (13-65)
Time Frame
Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Title
Cognitive fusion (Cognitive Fusion Scale; CFQ-7)
Description
Higher scores indicate higher levels of cognitive fusion (0-28)
Time Frame
Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Other Pre-specified Outcome Measures:
Title
Fear of contracting COVID-19 (Fear of contracting COVID-19 scale; FCCS)
Description
Higher scores indicate more fear of contracting COVID-19 (9-45)
Time Frame
Changes in results from: immediately pre-intervention and immediately post-intervention assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Inês Trindade
City
Coimbra
ZIP/Postal Code
3000-115
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)
We'll reach out to this number within 24 hrs