NCT05119608

Brief Summary

The present study is a pilot randomized controlled trial, which identifies and diagnoses mental health problems in survivors of critical COVID-19 infection at 12 months post-ICU care, and randomize patients to either an ACT-enforced CBT intervention, or to treatment as usual.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

2 active sites

Status
unknown

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

November 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

November 11, 2021

Last Update Submit

January 12, 2023

Conditions

COVID-19Mental Health Disorder

Keywords

COVID-19mental health disordercognitive-behavioral therapyacceptance and commitment therapyaddictive behaviorICU

Outcome Measures

Primary Outcomes (3)

  • Feasibility with respect to willingness for treatment study inclusion

    Proportion of patients screened who consent to and initiate the treatment study

    8 weeks post-assessment

  • Feasibility with respect to patient adherence

    Proportion of patients who remain in the treatment study including complete treatment settings and 2-week follow-up

    2 weeks post-treatment

  • Patient satisfaction with therapy intervention

    Therapy and Therapist Scale-Revised (STTS-R)

    2 weeks post-treatment

Secondary Outcomes (5)

  • Reduction of HADS anxiety score

    2 weeks, 3 and 12 months post-treatment

  • Reduction of HADS depression score

    2 weeks, 3 and 12 months post-treatment

  • Improved mental health-related quality of life

    2 weeks, 3 and 12 months post-treatment

  • Reduced fatigue

    2 weeks, 3 and 12 months post-treatment

  • Reduced post-traumatic symptoms

    2 weeks, 3 and 12 months post-treatment

Study Arms (2)

CBT/ACT

EXPERIMENTAL

Cognitive-behavioral therapy intervention with principal components of acceptance and commitment therapy (ACT)

Behavioral: CBT/ACT

TAU

ACTIVE COMPARATOR

Treatment as usual, defined by standard care, i.e. referral to relevant health care provider (typically primary care).

Behavioral: CBT/ACT

Interventions

CBT/ACTBEHAVIORAL

10-session ACT-re-enforced CBT intervention.

CBT/ACTTAU

Eligibility Criteria

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

You may qualify if:

  • COVID-19 survivors who screen positive for clinical anxiety or depression, defined as reaching a score of ≥ 8 on either the anxiety or depression sub-scales within the questionnaire HADS at the standard 12-months follow-up

You may not qualify if:

  • Conditions in which patients are acutely suicidal, psychotic, suffering from a mental disorder requiring in-patient psychiatric treatment, opposed to receiving a psycho-therapeutic intervention, or with cognitive problems or language difficulties which are judged to be too extensive for the informed consent procedure and for a psycho-therapeutic intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry

Malmo, 205 02, Sweden

RECRUITING

Södersjukhuset AB, Region Stockholm

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

COVID-19Mental DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCompulsive BehaviorImpulsive BehaviorBehavior

Central Study Contacts

Anders Håkansson, PhD

CONTACT

+46 46 175596anders_c.hakansson@med.lu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Study of a psycho-therapeutic intervention vs treatment as usual, therefore no masking of the treatment given.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, professor

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 15, 2021

Study Start

November 1, 2021

Primary Completion

September 30, 2022

Study Completion

November 15, 2025

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)