Skip to main content
OpenTrials
Completed

NCT Number: NCT06702254

Psychological Treatment in Psychiatric Inpatient Care.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psykiatri Nordväst

Stockholm, Sweden

About this study

The main questions the study aims to answer are:

  • Is cognitive behavioral therapy perceived as acceptable, comprehensible and helpful for patients in psychiatric inpatient ´care, when given by nursing staff in inpatient care?
  • Is cognitive behavioral therapy perceived as acceptable, understandable and helpful to the nursing staff who provided the treatment intervention?
  • Is cognitive behavioral therapy effective in reducing psychiatric symptoms such as depression, anxiety, and perceived health status for patients in psychiatric inpatient care when provided by nursing staff?

Participants are nursing staff from eight psychiatric inpatient wards and patients. The training consists of a two day workshop in the CBT manual followed by eight group supervision sessions parallell with patient treatment.

The patients are offered a CBT manual based psychological intervention with planned four treatment sessions but these can be flexibly prolonged to more sessions for repetition for patients staying for a longer period of time.

The study is a quasi-experimental design. Randomization takes place at ward level. The wards will be twin-matched based on patient problems and then randomized to treatment as usual (control group) or treatment as usual plus a CBT intervention (experimental group). Eight wards are included. Four wards will thus act as a control group and four wards as an experimental group. All within inpatient-care at Region Stockholm. The study aimed to include a total of 230 participants during 2020-2023. With a distribution ratio of 1:2, 77 participants are allocated to the experimental group and 153 participants to the control group, calculated on the basis of an expected effect size of 0.35 and a power of 0.8.

Patients who fulfill the inclusion criteria are informed about the study orally and in writing and are offered participation. Informed consent is collected upon offer of participation in the study. Patients are included consecutively as long as the ward and therapists have the available resources to accept more participants. Patients fill in self-report forms in connection with the usual enrollment and discharge routine. The self-report forms are questions about anxiety symptoms (GAD-7); perception of health (EQ-5D); depression symptoms (PHQ-9): experience of the intervention; Behavioral Activation Depression Scale-Short Form (BADS-SF); patient satisfaction. For the qualitative part with in-depth interviews, approx. 20 nursing staff are recruited. Semi-structured interview guide for nursing staff is created.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

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

Treatment and study plan

Experimental: Psychological manualized treatment with CBT and ACT

Behavioral

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.

Treatment as Usual

Other

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

Primary outcomes

  1. Behavioral Activation Depression Scale-Short Form (BADS-SF)

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

    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.

Secondary outcomes

  1. Generalized Anxiety Disorder-7 (GAD-7)

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

    A self-report containing seven questions that measures various aspects of subjective worry, anxiety and stress over the course of the past two weeks. Minimum value is 0 and maximum value 3. Higher scores indicate more anxiety and worry.

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

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

    The EQ-5D is a self-report that consists of five dimensions: mobility, self care, daily activities, pain/discomfort, anxiety/depression. The EQ-5D also contains a visual analogue scale where patients can rate their overall health. Higher scores indicate better overall health and well being.

  3. Patient Health Questionnaire (PHQ-9)

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

    The PHQ-9 is a self-report with nine questions if patients have experienced depression, hopelessness or futility during the last two weeks. A minimum value of 0 and a maximum value of 3. Higher scores indicate more depression symtoms.

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

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

    A self-report used for all patients in psychiatric in-patient care nationally at discharge. The self-report contains five questions. Higher scores indicate more satisfaction with the in-patient care.

  5. Experience of the psychological treatment

    Time frame: Post treatment, an average of two weeks.

    A self-report questionnaire created within the research group for this intervention. The self-report consists of seven questions that measures the patients experience of the intervention. The scores range from 1 to 7. Higher scores indicate a greater experience and satisfaction.

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Psychological Treatment Based on Cognitive Behavior Therapy Delivered by Mental Health Care Staff in Acute Psychiatric Inpatient Care.

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.