Psykiatri Nordväst
Stockholm, Sweden
NCT Number: NCT06702254
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stockholm, Sweden
The main questions the study aims to answer are:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
This treatment as usual can consist of medication, brief talks, leisure activity on the wards.
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.
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.
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.
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.
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.
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.
Region Stockholm
Other Gov
Psychological Treatment Based on Cognitive Behavior Therapy Delivered by Mental Health Care Staff in Acute Psychiatric Inpatient Care.
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