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Completed

NCT Number: NCT04408651

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

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.

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Key information

Conditions

Chronic Medical Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inês Trindade

Coimbra, 3000-115, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIIT.CI ACT

Behavioral

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

LIIT.CI CFT

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

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

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

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

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

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

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

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

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

    Higher scores indicate higher levels of self-compassion (subscale of the Self-compassion scale) (13-65)

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

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

    Higher scores indicate higher levels of self-cristicism (subscale of the Self-compassion scale) (13-65)

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

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

    Higher scores indicate higher levels of cognitive fusion (0-28)

Other outcomes

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

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

    Higher scores indicate more fear of contracting COVID-19 (9-45)

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 29, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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