NCT04704973

Brief Summary

The project aims to investigate the effects of a short-term cbt-based psychotherapy intervention for a diagnostically mixed group of psychiatric inpatients. In a multiple baseline single subject design, 5-10 patients with mixed diagnoses that are treated at any of the inpatient units at the Hospital of Västmanland, Västerås, Sweden, will be offered a short psychotherapeutic intervention. The intervention is cbt based, and consists of focused functional analysis with identification of the main problem to be treated; an experiential exercise called the life line, in which obstacles to living a valued life are investigated, and in which alternative steps to be taken in spite of psychiatric symptoms are formulated; a summary excercise called the pause, in which central principles of the treatment are repeated, and in which a relapse prevention plan is formulated. The intervention will consist of approximately 2-5 sessions. The primary research question is whether such an intervention is effective in terms of causal change in problem areas identified as personally meaningful by the individual patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

October 27, 2020

Last Update Submit

April 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Personal Questionnaire

    A numeric idiographic measure of change in individual presenting symptoms. 1-4 points, higher points reflecting worse outcome.

    2-3 times daily approximately 1-2 days prior to intervention, 2-3 times daily during intervention, and 2-3 times daily for 2-3 days after intervention.

Secondary Outcomes (1)

  • Bull's-Eye Values Survey

    2-3 times daily approximately 1-2 days prior to intervention, 2-3 times daily during intervention, and 2-3 times daily for 2-3 days after intervention.

Study Arms (1)

Transdiagnostic short-term psychotherapy

EXPERIMENTAL
Behavioral: Transdiagnostic short-term psychotherapy

Interventions

Focused clinical functional analysis, formulation of a valued life direction includings strategies to handle obstacles, and a summarizing exercise including relapse prevention.

Transdiagnostic short-term psychotherapy

Eligibility Criteria

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

You may qualify if:

  • Patient treated at any of the inpatient wards at Hospital of Västmanland, Västerås, Sweden, with any diagnosis or combination of diagnoses.
  • Cognitive level such that informed consent can be given.
  • A stable baseline with regards to the chosen dependent variable.

You may not qualify if:

  • Other ongoing psychological treatment on the ward.
  • Cognitive deficits that prevent the giving of informed consent.
  • Unstable baseline.

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

Mental Disorders

Study Officials

  • Kent Nilsson, PhD

    Uppsala University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-case experimental design, with a multiple baseline across participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

January 12, 2021

Study Start

November 2, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations