Psychological Treatment in Psychiatric Inpatient Care

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.

Study Overview

• Status: Terminated
• Conditions: Psychosis; Psychiatric Disorder; Psychiatric Hospitalization; Compulsory Psychiatric Care Act; Acceptance & Commitment Therapy
• Intervention / Treatment: Behavioral: ACT

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mårten J Tyrberg, PhD; Phone Number: +4621174373; Email: marten.tyrberg@regionvastmanland.se

Study Locations

• Sweden
  • Västmanland
    • Västerås, Västmanland, Sweden, 72189
      • Hospital of Västmanland, Västerås

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Acceptance & Commitment Therapy (ACT); Psyhotherapy based on principles of functional analysis, behavioral activation, and experiential avoidance.

Behavioral: ACT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Study Director: Kent Nilsson, Professor, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: 280468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No