NCT06702254

Brief Summary

There is a lack of psychological treatments within inpatient psychiatric care while there is support for active psychological interventions having an effect on psychiatric problems. The purpose of the present feasibility study is to test whether a psychological treatment based on Cognitive Behavioral therapy (CBT) and Acceptande and Commitment therapy (ACT) for patients in psychiatric inpatient care is acceptable, understandable, helpful and effective both for patients and the staff who carry out the treatment. The therapist in the project will receive training and on-going supervision in a CBT-manual created within the research group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 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

Study Start

First participant enrolled

December 5, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

November 8, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

Cognitive behavioral therapyAcceptance and commitment therapyPsychiatric inpatient care

Outcome Measures

Primary Outcomes (1)

  • Behavioral Activation Depression Scale-Short Form (BADS-SF)

    A self-report with nine questions that measures current activity level and satisfaction linked to activity under the present week inclusive of today. Scale scores are from 0 to 6 with a maximum of 54. Higher scores indicate a greater level of activity and satisfaction.

    Change from pre intervention to post intervention at treatment end, up to four weeks.

Secondary Outcomes (5)

  • Generalized Anxiety Disorder-7 (GAD-7)

    Change from pre intervention to post intervention at treatment end, up to four weeks.

  • Experience of Health (EQ-5D) (EuroQol, https://euroquol.org)

    Change from pre intervention to post intervention at treatment end, up to four weeks.

  • Patient Health Questionnaire (PHQ-9)

    Change from pre intervention to post intervention at treatment end, up to four weeks.

  • Patient Satisfaction (https://patientenkat.se/sv/)

    Change from pre intervention to post intervention at treatment end, up to four weeks.

  • Experience of the psychological treatment

    Post treatment, an average of two weeks.

Study Arms (2)

Treament as usual

OTHER

The in-ward patient are provided treatment as usual. This can include medication, routine brief conversation and ward activity.

Other: Treatment as usual

Psychological manualized treatment with CBT and ACT

EXPERIMENTAL

The intervention is based on a manual and is an add-on to treatment as usual. In-ward patients are offered a brief psychological treatment based on core features from CBT and ACT such as behavioral activation and work on values and unhelpful thoughts. Prior to the intervention nursing staff receive training in the manual followed by supervision during the treatment intervention. The treatment in this condition is an add-on to usual treatment given in the wards. The intervention is brief up to four sessions in the manual but can be shortened or extended to fit the patients admission time.

Behavioral: Experimental: Psychological manualized treatment with CBT and ACT

Interventions

The intervention is brief and centered around four therapeutic sessions that can be extended or shortened depending on how long patients are hospitalized. Core techniques from CBT and ACT are included in the manual and consists of behavioral activation and values and unhelpful thoughts. Nursing staff on these wards have received training in the manual parallel with supervision which is not given in the treatment as usual wards. The wards that have not received the intervention will be offered this at the end of their TAU period.

Psychological manualized treatment with CBT and ACT

This treatment as usual can consist of medication, brief talks, leisure activity on the wards.

Treament as usual

Eligibility Criteria

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

You may qualify if:

  • Meet criteria for and are enrolled in psychiatric inpatient care.
  • Agree to participate in the study.
  • Assessed to be stable enough to participate in a conversation after a routine ward medical assessment (do they understand what they are agreeing to/not to, can communicate, etc.)

You may not qualify if:

  • \* Other ongoing intensive psychotherapy (e.g. in outpatient care that continues during the psychiatric inpatient care stay).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykiatri Nordväst

Stockholm, Sweden, Sweden

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Lena Reuterskiöld PhD

    Region Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 22, 2024

Study Start

December 5, 2020

Primary Completion

December 15, 2023

Study Completion

June 30, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

IPD for this data set can not be made available on the individual participant level due to consent given by participants during project time since 2020. Although data on group level including measures of variance and details of statistical analysis plan will be shared to researchers on request.

Locations