Chronic Medical ConditionsNCT04408651
Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)
A study testing LIIT.CI ACT and LIIT.CI CFT in people with Chronic Medical Conditions, run by University of Coimbra at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Medical Conditions
- What is being tested?
- LIIT.CI ACT and LIIT.CI CFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65
- Previous diagnosis of a physical chronic medical condition
- Easy access to internet and to a computer
Who cannot join
- Receiving psychological intervention
- Diagnosis of a severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Medical Conditions
- Being tested
- LIIT.CI ACT, LIIT.CI CFT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIIT.CI ACTBehavioural
4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions
LIIT.CI CFTBehavioural
4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Not described Receives: Behavioral: LIIT.CI ACT |
| Compassion-Focused Therapy | Experimental | Not described Receives: Behavioral: LIIT.CI CFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)
Higher scores indicate more depression and anxiety symptoms (0-21)
Measured: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Secondary outcomes (5)
Illness shame (Chronic Illness Shame Scale; CISS)
Higher scores indicate higher levels of illness shame (0-28)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 May 2020
- Primary completion31 Dec 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inês A Trindade, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408651
- Sponsor's protocol ID
- LIIT
- Status last verified
- May 2022
- First submitted
- 20 May 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI): Testing the Efficacy of ACT and CFT Interventions
- ClinicalTrials.gov ID
- NCT04408651
- Acronym / sponsor ID
- LIIT
- Conditions
- Chronic Medical Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: LIIT.CI ACT |
| Compassion-Focused Therapy | Experimental | Behavioral: LIIT.CI CFT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65
- Previous diagnosis of a physical chronic medical condition
- Easy access to internet and to a computer
Key exclusion criteria (2 listed)
- Receiving psychological intervention
- Diagnosis of a severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIIT.CI ACT4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions | Behavioural | Acceptance and Commitment Therapy |
| LIIT.CI CFT4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions | Behavioural | Compassion-Focused Therapy |
Primary outcome
Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)
Time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Higher scores indicate more depression and anxiety symptoms (0-21)
5 secondary outcomes
Illness shame (Chronic Illness Shame Scale; CISS)
Time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)
Time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Self-compassion (Self-compassion scale; SCS)
Time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Self-criticism (Self-compassion scale; SCS)
Time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Cognitive fusion (Cognitive Fusion Scale; CFQ-7)
Time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIIT.CI ACT and LIIT.CI CFT in people with Chronic Medical Conditions, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression and anxiety (Hospital Anxiety and Depression Scales; HADS) (time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.