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Psychological Treatment in Psychiatric Inpatient Care.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06702254
Enrollment
60
Registered
2024-11-22
Start date
2020-12-05
Completion date
2024-06-30
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and Depression, Psychiatric Inpatients

Keywords

Cognitive behavioral therapy, Acceptance and commitment therapy, Psychiatric inpatient care

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.

Detailed description

The main questions the study aims to answer are: 1. Is cognitive behavioral therapy perceived as acceptable, comprehensible and helpful for patients in psychiatric inpatient ´care, when given by nursing staff in inpatient care? 2. Is cognitive behavioral therapy perceived as acceptable, understandable and helpful to the nursing staff who provided the treatment intervention? 3. 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.

Interventions

BEHAVIORALExperimental: Psychological manualized treatment with CBT and ACT

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.

OTHERTreatment as usual

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

Sponsors

Karolinska Institutet
CollaboratorOTHER
Region Stockholm
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Behavioral Activation Depression Scale-Short Form (BADS-SF)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

MeasureTime frameDescription
Generalized Anxiety Disorder-7 (GAD-7)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.
Experience of Health (EQ-5D) (EuroQol, https://euroquol.org)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.
Patient Health Questionnaire (PHQ-9)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.
Patient Satisfaction (https://patientenkat.se/sv/)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.
Experience of the psychological treatmentPost 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026