Anxiety and DepressionNCT06702254
Psychological Treatment in Psychiatric Inpatient Care.
A study testing Experimental: Psychological manualized treatment with CBT and ACT and Treatment as usual in people with Anxiety and Depression and Psychiatric Inpatients, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety and Depression, Psychiatric Inpatients
- What is being tested?
- Experimental: Psychological manualized treatment with CBT and ACT and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 5 Dec 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- Other ongoing intensive psychotherapy (e.g. in outpatient care that continues during the psychiatric inpatient care stay).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Treatment Based on Cognitive Behavior Therapy Delivered by Mental Health Care Staff in Acute 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.
Read the detailed description
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.
- Conditions
- Anxiety and Depression, Psychiatric Inpatients
- Being tested
- Experimental: Psychological manualized treatment with CBT and ACT, Treatment as usual
- Keywords
- Cognitive behavioral therapy, Acceptance and commitment therapy, Psychiatric inpatient care
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Psychological manualized treatment with CBT and ACTBehavioural
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 usualOther
This treatment as usual can consist of medication, brief talks, leisure activity on the wards.
| Study group | Role | What they receive |
|---|---|---|
| Treament as usual | Other | The in-ward patient are provided treatment as usual. This can include medication, routine brief conversation and ward activity. Receives: Other: Treatment as usual |
| Psychological manualized treatment with CBT and ACT | Experimental | The intervention is based on a manual and is an add-on to treatment as usual. In-ward patients are offered a brief psychological treatment based on core features from CBT and ACT such as behavioral activation and work on values and unhelpful thoughts. Prior to the intervention nursing staff receive training in the manual followed by supervision during the treatment intervention. The treatment in this condition is an add-on to usual treatment given in the wards. The intervention is brief up to four sessions in the manual but can be shortened or extended to fit the patients admission time. Receives: Behavioral: Experimental: Psychological manualized treatment with CBT and ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Activation Depression Scale-Short Form (BADS-SF)
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.
Measured: Change from pre intervention to post intervention at treatment end, up to four weeks.
Secondary outcomes (5)
Generalized Anxiety Disorder-7 (GAD-7)
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.
Measured: Change from pre intervention to post intervention at treatment end, up to four weeks.
Experience of Health (EQ-5D) (EuroQol, https://euroquol.org)
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.
Measured: Change from pre intervention to post intervention at treatment end, up to four weeks.
Patient Health Questionnaire (PHQ-9)
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.
Measured: Change from pre intervention to post intervention at treatment end, up to four weeks.
Patient Satisfaction (https://patientenkat.se/sv/)
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.
Measured: Change from pre intervention to post intervention at treatment end, up to four weeks.
Experience of the psychological treatment
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.
Measured: Post treatment, an average of two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start5 Dec 2020
- Primary completion15 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and DepressionStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Lena Reuterskiold, Region Stockholm
- Investigators
- Lena Reuterskiöld PhD, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702254
- Sponsor's protocol ID
- 2020-01169
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD for this data set can not be made available on the individual participant level due to consent given by participants during project time since 2020. Although data on group level including measures of variance and details of statistical analysis plan will be shared to researchers on request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment Based on Cognitive Behavior Therapy Delivered by Mental Health Care Staff in Acute Psychiatric Inpatient Care.
- ClinicalTrials.gov ID
- NCT06702254
- Acronym / sponsor ID
- 2020-01169
- Conditions
- Anxiety and Depression, Psychiatric Inpatients
- Keywords
- Cognitive behavioral therapy, Acceptance and commitment therapy, Psychiatric inpatient care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treament as usual | Other | Other: Treatment as usualThe in-ward patient are provided treatment as usual. This can include medication, routine brief conversation and ward activity. |
| Psychological manualized treatment with CBT and ACT | Experimental | Behavioral: Experimental: Psychological manualized treatment with CBT and ACTThe intervention is based on a manual and is an add-on to treatment as usual. In-ward patients are offered a brief psychological treatment based on core features from CBT and ACT such as behavioral activation and work on values and unhelpful thoughts. Prior to the intervention nursing staff receive training in the manual followed by supervision during the treatment intervention. The treatment in this condition is an add-on to usual treatment given in the wards. The intervention is brief up to four sessions in the manual but can be shortened or extended to fit the patients admission time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (1 listed)
- Other ongoing intensive psychotherapy (e.g. in outpatient care that continues during the psychiatric inpatient care stay).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Psychological manualized treatment with CBT and ACTThe 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. | Behavioural | Psychological manualized treatment with CBT and ACT |
| Treatment as usualThis treatment as usual can consist of medication, brief talks, leisure activity on the wards. | Other | Treament as usual |
Primary outcome
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.
5 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Change from pre intervention to post intervention at treatment end, up to four weeks.
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.
Patient Health Questionnaire (PHQ-9)
Time frame: Change from pre intervention to post intervention at treatment end, up to four weeks.
Patient Satisfaction (https://patientenkat.se/sv/)
Time frame: Change from pre intervention to post intervention at treatment end, up to four weeks.
Experience of the psychological treatment
Time frame: Post treatment, an average of two weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No. IPD for this data set can not be made available on the individual participant level due to consent given by participants during project time since 2020. Although data on group level including measures of variance and details of statistical analysis plan will be shared to researchers on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Reuterskiöld PhD principal investigator
Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Psychological manualized treatment with CBT and ACT and Treatment as usual in people with Anxiety and Depression and Psychiatric Inpatients, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Activation Depression Scale-Short Form (BADS-SF) (time frame: Change from pre intervention to post intervention at treatment end, up to four weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.