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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Medical Conditions

Intervention / Treatment
-----------------
* Behavioral: LIIT.CI ACT
* Behavioral: LIIT.CI CFT


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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 |