Cognitive Behavior Therapy in Psychiatric Inpatient Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRegion Stockholm

About this trial

The current project aims to evaluate the extent to which psychological interventions based on Cognitive Behavioral Therapy (CBT), provided within the framework of care, may be helpful for patients in psychiatric inpatient care. The background to the project is the substantial lack of psychological treatment available to patients in psychiatric inpatient care, despite evidence suggesting that active psychological interventions can have a positive effect on psychiatric problems, such as reduced depressive symptoms, decreased anxiety, and reduced rates of readmission to inpatient psychiatric care. Previous research evaluating the effects of CBT in inpatient settings is, however, rare and more knowledge is needed both nationally and internationally. In addition to the potential direct effect of psychological treatment on patients' difficulties, there is also a high demand for such support from patients, for example, as expressed at patient forums conducted by participation coordinators in Region Stockholm, Sweden. In psychiatric outpatient and primary care, there is currently good evidence supporting CBT, and these methods are highly beneficial for both patients and practitioners. Digitalization and blended formats, with therapist-supported internet treatments, can also increase access to interventions. Studies of CBT for, for example, depression, anxiety, and psychosis are well documented and have shown a significant reduction in psychiatric symptoms as well as improved quality of life. But scarcity of studies conducted in inpatient care limits available knowledge on feasibility and effects of CBT interventions to this group of patients. This strongly motivates further systematic evaluation and research on CBT in inpatient psychiatric care, and the aim of the present study is to implement and evaluate CBT in this context. Investigators plan to test this at four to six psychiatric inpatient units and evaluate the impact of the intervention on patients' levels of activity and symptoms of low mood and depression in a randomized controlled trial. In addition, investigators wish to conduct two different interview studies with patients and staff to obtain a detailed description of how they experience the intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted as patient in Psychiatric Inpatient Care

Expected to remain admitted on the ward for at least 3 days

Assessed as being capable of giving consent regarding participation.

Assessed as able to engage in and complete conversations.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive Behavioral Therapy

    Behavioral

    Inpatients at the ward receives manual-based CBT during admission. The sessions are delivered by mental health professionals.

  • treatment as usual (TAU) (Control Group)

    Other intervention

    Including medical treatment, other activities at the ward, offering of daily conversations (DC)

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Treatment as usual (TAU)Other 1 intervention
Group B: Cognitive Behavioral TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Measures self-reported level of behavioral activation. 9 items with a total score of 0-54. Higher scores indicates higher levels of behavioral activation.

Time frame
Change from baseline (at admission) to discharge, up to four weeks. Follow-up will be collected three months and one year following discharge.
2

Clinical Outcomes in Routine Evaluation - 10 (CORE-10)

CORE-10 measures mental health, capturing a broad range of psychological and functional domains. It consists of 10 items (0-4) and scoring results in a total score with higher scores indicating more psychiatric symptoms.

Time frame
Change from baseline (at admission) to discharge, up to four weeks. Follow-up will be collected three months and one year following discharge.

Secondary outcomes

1

EQ-5D-5L (EuroQol)

Measures of self-reported level of health. Scoring results in two separate variables, (1) a self-reported VAS-scale ranging from 0 to 100 where higher scoring indicates higher levels of health, and (2) an index from 0 to 1 where higher index indicate higher levels of health.

Time frame
Change from baseline (at admission) to discharge, up to four weeks. Follow-up will be collected three months and one year following discharge.
2

Days in inpatient psychiatric care

Each participants amount of days admitted in inpatient psychiatric care. Data are retrieved from participants medical records.

Time frame
(1) three months prior to admission, and (2) three months following discharge. Follow-up will be collected during three months up to one year following discharge.
3

Clinical Global Impression (CGI)

CGI is a structured three-item observer-rated tool to capture severity of problems (CGI-S), improvement (CGI-I), and treatment efficacy (CGI-E). For the purpose of this study, the first two items will be used. The rating gives a score ranging from 1 to 7. On CGI-S, lower scores indicate less severity of problems. On CGI-I, lower scores indicate more improvement.

Time frame
Change from baseline (at admission) to discharge, up to four weeks. Follow-up will be collected three months and one year following discharge.

Other outcomes

1

Experience of the psychosocial support/conversations in PIC

A self-report questionnaire with 7 items capturing the patients experiences of the intervention. Items are rated from 1 to 7 with a total score of 7 to 49. Higher ratings indicate higher levels of positive experiences of the support.

Time frame
Administered to participants up to four weeks from admission/baseline.
2

Patient satisfaction

A self-report questionnaire to capture satisfaction of inpatient care. Three items are rated from 0 to 10. Higher ratings indicate higher levels of satisfaction. An open-ended question to capture more elaborate answers is included.

Time frame
Administered to participants up to four weeks from admission/baseline.

Sponsors and contacts

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Region Stockholm

Lead sponsor

Karolinska Institutet

Collaborator

Stockholm University

Collaborator