NCT04408651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

May 20, 2020

Last Update Submit

May 16, 2022

Conditions

Chronic Medical Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Illness shame (Chronic Illness Shame Scale; CISS)

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

  • Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)

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

  • Self-compassion (Self-compassion scale; SCS)

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

  • Self-criticism (Self-compassion scale; SCS)

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

  • Cognitive fusion (Cognitive Fusion Scale; CFQ-7)

    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)

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

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL
Behavioral: LIIT.CI ACT

Compassion-Focused Therapy

EXPERIMENTAL
Behavioral: LIIT.CI CFT

Interventions

LIIT.CI ACTBEHAVIORAL

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

Acceptance and Commitment Therapy
LIIT.CI CFTBEHAVIORAL

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

Compassion-Focused Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65
  • Previous diagnosis of a physical chronic medical condition
  • Easy access to internet and to a computer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inês Trindade

Coimbra, 3000-115, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 29, 2020

Study Start

May 1, 2020

Primary Completion

December 31, 2020

Study Completion

August 31, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

PT(1)