Cognitive Behavior Therapy in Psychiatric Inpatient Care

NCT07503951 | Recruiting

• 1 other identifier: Region Stockholm
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Anxiety Disorders; Psychiatric Inpatients

Keywords

Cognitive Behavioral Therapy; Inpatient Psychiatric Care; Mental Health Professionals

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  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 (3)

• EQ-5D-5L (EuroQol)

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

• Days in inpatient psychiatric care

  (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.

• Clinical Global Impression (CGI)

  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 (2)

• Experience of the psychosocial support/conversations in PIC

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

• Patient satisfaction

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

Study Arms (2)

Treatment as usual (TAU)

OTHER

Participants in this arm are provided the treatment usually given during admission at the ward. This includes medication, routine brief conversation offered daily, and other activities at the ward.

Other: treatment as usual (TAU) (Control Group)

Cognitive Behavioral Therapy

EXPERIMENTAL

Patients are given therapeutic conversations during admission. The sessions are delivered by mental health professionals at the ward who have received training in the structure of the manual and specific interventions included. The interventions delivered during the therapeutic conversations are based on Cognitive Behavior Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Behavioral Activation(BA).

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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

Cognitive Behavioral Therapy

treatment as usual (TAU) (Control Group) OTHER

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

Treatment as usual (TAU)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Sufficient level of language skills to understand the content of conversations and client material included in the intervention.

You may not qualify if:

• Other ongoing psychotherapeutic contact.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator
• Stockholm University: collaborator

Study Sites (1)

Centrum för psykiatriforskning, Region Stockholm

Stockholm, 11354, Sweden

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy; Therapeutics; Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Johan Holmberg, PhD

  Centre for Psychiatry Research, Region Stockholm/Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Holmberg, PhD

CONTACT

+46708235089; johan.holmberg.1@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available when the manuscript will be submitted. The planned date for submitting the manuscript for this study is December 2028.

Locations

SE (1)