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CompletedNCT04408651Updated May 18, 2022

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

An interventional study of LIIT.CI ACT and LIIT.CI CFT in Chronic Medical Conditions, sponsored by University of Coimbra. Completed at 1 site in Portugal. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by University of Coimbra · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Medical Conditions
03

In context

Lead sponsor

University of Coimbra is the lead sponsor of 87 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Receiving psychological intervention
  • Diagnosis of a severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or cognitive impairment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Acceptance and Commitment Therapy

    Behavioral: LIIT.CI ACT

  • Experimental
    Compassion-Focused Therapy

    Behavioral: LIIT.CI CFT

Interventions

  • BehavioralLIIT.CI ACT

    4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions

  • BehavioralLIIT.CI CFT

    4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions

06

What researchers measure

Primary outcomes

  1. Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)

    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 outcomes

  1. Illness shame (Chronic Illness Shame Scale; CISS)

    Higher scores indicate higher levels of illness shame (0-28)

    Time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments

  2. Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)

    Higher scores indicate higher levels of psychological flexibility (0-108)

    Time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments

  3. Self-compassion (Self-compassion scale; SCS)

    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

  4. Self-criticism (Self-compassion scale; SCS)

    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

  5. Cognitive fusion (Cognitive Fusion Scale; CFQ-7)

    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 outcomes

  1. Fear of contracting COVID-19 (Fear of contracting COVID-19 scale; FCCS)

    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

07

Study locations

1 site
  • Inês Trindade
    Coimbra, 3000-115, Portugal
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2020 to primary completion in Dec 2020, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2020
First posted
May 29, 2020
StartActual
May 1, 2020
Primary completionActual
Dec 31, 2020
CompletionActual
Aug 31, 2021
Last update
May 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04408651
Lead sponsor
University of Coimbra
Responsible party
Inês A Trindade (Principal Investigator, University of Coimbra) — Principal investigator
First posted
May 29, 2020
Start date
May 1, 2020
Primary completion
Dec 31, 2020
Completion
Aug 31, 2021
Last update
May 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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