NCT06012981

Brief Summary

This study aims to investigate the effect of a brief psychotherapeutic treatment intervention based on ACT, aimed specifically at the vulnerable group of patients in psychiatric 24-hour care treated according to LPT. The study aims to investigate whether a brief number of therapeutic sessions according to ACT during inpatient care produce positive effects on personally relevant life areas for a diagnostically mixed group of patients in a psychiatric intensive care unit.

Trial Health

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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

April 28, 2023

Last Update Submit

December 13, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in Personal Questionnaire

    Scores range from 1-4 per item (number of items might differ between patients as the measure is individually constructed. Higher scores correspond to worse outcome.

    Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session

  • Change in Bull's Eye Values Survey

    The score ranges from 0-28, higher scores corresponding to better outcome.

    Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session

  • Change in PHQ-9

    The score ranges from 0-27, higher scores corresponding to worse outcome.

    Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session

  • Change in GAD-7

    The score ranges from 0-21, higher scores corresponding to worse outcome.

    Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session

  • Change in Psy-flex

    The score ranges from 6-30, higher scores corresponding to better outcome.

    Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session

Study Arms (1)

Acceptance & Commitment Therapy (ACT)

EXPERIMENTAL

Psyhotherapy based on principles of functional analysis, behavioral activation, and experiential avoidance.

Behavioral: ACT

Interventions

ACTBEHAVIORAL

The treatment is based on a variant of CBT, as briefly referred to before, ACT. In short, the treatment consists of identifying central and important areas of life, and how to approach these even though you are also struggling with persistent and challenging problems. In this study, the treatment intervention is flexibly constructed, focusing on several central principles based on ACT. These can be applied during one or numerous sessions. The intervention is a flexible application of clinical functional analysis, as well as a couple of selected interventions which, in terms of experience and in previous studies, have been shown to work well for the current group (24-hour psychiatric patients with complex problems) and which are individually adaptable to the nature of the problem and degree.

Acceptance & Commitment Therapy (ACT)

Eligibility Criteria

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

You may qualify if:

  • years old or older.
  • Treated according to the compulsory psychiatric care act.
  • Meet the criterion of informed consent.

You may not qualify if:

  • Lack the cognitive ability to acquire the treatment intervention, such as impaired attention, memory, logic and reasoning, and also auditory and visual processing. This will be based on a clinical assessment by the ward team, including the attending psychiatrist and a clinical psychologist.
  • Ongoing psychological treatment parallel to the admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Västmanland, Västerås

Västerås, Västmanland County, 72189, Sweden

Location

MeSH Terms

Conditions

Psychotic DisordersMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Kent Nilsson, Professor

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-case experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2023

First Posted

August 28, 2023

Study Start

September 1, 2023

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations