Anxiety DisordersNCT05379244
Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study
A study testing CBT-i in people with Anxiety Disorders and Affective Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. In addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Affective Disorders, PTSD
- What is being tested?
- CBT-i
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to 31 Jan 2020
- 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
- Being a patient at a specialist outpatient clinic treating these patient groups
- Insomnia disorder or sleep problems of insomnia type
- Over 10 points on the Insomnia Severity Index (ISI)
- Adequate skills in written and spoken Swedish
- No practical barriers to participate in the group treatment
Who cannot join
- night shift work
- ongoing alcohol or drug abuse that required treatment at a specialised unit
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry
Stockholm, 141 86
About this study
Official title: Better Sleep in Psychiatric Care - Clinical Feasibility and Preliminary Effects of CBT for Insomnia in a Mixed Psychiatric Sample at an Outpatient Clinic
Between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. In addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. According to international guidelines, cognitive behavioral therapy for insomnia (CBT-i) should be used as the first choice for treatment of insomnia. In practice, however, it is very uncommon for psychiatric patients to be offered CBT-i, instead most are treated with sleep medications. There is also a lack of research studies evaluating CBT-i in regular clinical practice.
This pilot study investigated the feasibility of a group treatment with CBT-i at a psychiatric outpatient clinic in Stockholm for patients with depression, bipolar disorder II, anxiety syndrome and PTSD. Changes in symptoms of insomnia, depression, and anxiety after treatment were also investigated.
Read more
Patients with self-perceived sleep problems were offered a six-session group treatment based on CBT-i. The primary outcome was clinical feasibility, defined as: the influx of patients sufficient to start at least one group per semester (at least 8 patients); at least half of included patients participate in the first session; patients participate in at least half of the sessions; less than half of the patients drop out of treatment; group leaders find the treatment manual credible, easy to use and want to continue working with it after the study is completed.
Secondary outcomes were changes in insomnia symptoms, and changes in symptoms of depression and anxiety.
- Conditions
- Anxiety Disorders, Affective Disorders, PTSD, Insomnia Chronic
- Being tested
- CBT-i
- Keywords
- CBT-i
- Medical subject headings
- Anxiety Disorders, Mood Disorders, Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-iBehavioural
Behavioral intervention based on Cognitive Behavioral Therapy for insomnia, adjusted for psychiatric patients with anxiety disorders, affective disorders and trauma
| Study group | Role | What they receive |
|---|---|---|
| CBT-i | Experimental | Cognitive Behavioral Therapy for insomnia adjusted for patients with mixed psychiatric disorders Receives: Behavioral: CBT-i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants registering to participate in the treatment
Influx of patients should be sufficient to start at least one group per semester (at least 8 patients)
Measured: Screening
Number of included participants attending the first treatment session
At least half of included patients should attend the first treatment session
Measured: First session (1 week)
Number sessions attended by the participants
Average number of sessions attended should be no less than 3
Measured: Post-treatment (6 weeks)
Number of participants dropping out of treatment
Less than half of the patients should drop out of treatment
Measured: Post-treatment (6 weeks)
Qualitative measure of group leaders' perception of the manual
Group leaders should find the treatment manual credible and easy to use, and be willing to continue using the treatment manual after the study is completed
Measured: Post-treatment (6 weeks)
Secondary outcomes (3)
Insomnia Severity Index
7-item self-reported measure of insomnia severity, 0-28 points, lower is better.
Measured: Post-treatment (6 weeks), Three-month follow-up (21 weeks)
Patient health questionnaire (PHQ-9)
9-item depression inventory, 0-27 points, lower is better
Measured: Post-treatment (6 weeks), Three-month follow-up (21 weeks)
Generalized Anxiety Disorder Assessment (GAD-7)
7-item anxiety inventory, 0-21 points, lower is better
Measured: Post-treatment (6 weeks), Three-month follow-up (21 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jan 2019
- Primary completion1 Oct 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Pragmatic, within-group pilot study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Susanna Jernelöv, Karolinska Institutet
- Investigators
- Susanna Jernelöv, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379244
- Sponsor's protocol ID
- 2018/80-31/1a
- Status last verified
- Jun 2022
- First submitted
- 10 May 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cassel M, Blom K, Gatzacis J, Renblad P, Kaldo V, Jernelov S. Clinical feasibility of cognitive behavioural therapy for insomnia in a real-world mixed sample at a specialized psychiatric outpatient clinic. BMC Psychiatry. 2022 Sep 9;22(1):600. doi: 10.1186/s12888-022-04231-4.
PubMed 36085009
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Sleep in Psychiatric Care - Clinical Feasibility and Preliminary Effects of CBT for Insomnia in a Mixed Psychiatric Sample at an Outpatient Clinic
- ClinicalTrials.gov ID
- NCT05379244
- Acronym / sponsor ID
- 2018/80-31/1a
- Conditions
- Anxiety Disorders, Affective Disorders, PTSD, Insomnia Chronic
- Keywords
- CBT-i
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 May 2022 (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.
Between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. In addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. According to international guidelines, cognitive behavioral therapy for insomnia (CBT-i) should be used as the first choice for treatment of insomnia. In practice, however, it is very uncommon for psychiatric patients to be offered CBT-i, instead most are treated with sleep medications. There is also a lack of research studies evaluating CBT-i in regular clinical practice.
This pilot study investigated the feasibility of a group treatment with CBT-i at a psychiatric outpatient clinic in Stockholm for patients with depression, bipolar disorder II, anxiety syndrome and PTSD. Changes in symptoms of insomnia, depression, and anxiety after treatment were also investigated.
Patients with self-perceived sleep problems were offered a six-session group treatment based on CBT-i. The primary outcome was clinical feasibility, defined as: the influx of patients sufficient to start at least one group per semester (at least 8 patients); at least half of included patients participate in the first session; patients participate in at least half of the sessions; less than half of the patients drop out of treatment; group leaders find the treatment manual credible, easy to use and want to continue working with it after the study is completed.
Secondary outcomes were changes in insomnia symptoms, and changes in symptoms of depression and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Pragmatic, within-group pilot study
| Arm | Type | Receives |
|---|---|---|
| CBT-i | Experimental | Behavioral: CBT-iCognitive Behavioral Therapy for insomnia adjusted for patients with mixed psychiatric disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being a patient at a specialist outpatient clinic treating these patient groups
- Insomnia disorder or sleep problems of insomnia type
- Over 10 points on the Insomnia Severity Index (ISI)
- Adequate skills in written and spoken Swedish
- No practical barriers to participate in the group treatment
Key exclusion criteria (2 listed)
- night shift work
- ongoing alcohol or drug abuse that required treatment at a specialised unit
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 |
|---|---|---|
| CBT-iBehavioral intervention based on Cognitive Behavioral Therapy for insomnia, adjusted for psychiatric patients with anxiety disorders, affective disorders and trauma | Behavioural | CBT-i |
Primary outcome
Number of participants registering to participate in the treatment
Time frame: Screening
Influx of patients should be sufficient to start at least one group per semester (at least 8 patients)
Number of included participants attending the first treatment session
Time frame: First session (1 week)
At least half of included patients should attend the first treatment session
Number sessions attended by the participants
Time frame: Post-treatment (6 weeks)
Average number of sessions attended should be no less than 3
Number of participants dropping out of treatment
Time frame: Post-treatment (6 weeks)
Less than half of the patients should drop out of treatment
Qualitative measure of group leaders' perception of the manual
Time frame: Post-treatment (6 weeks)
Group leaders should find the treatment manual credible and easy to use, and be willing to continue using the treatment manual after the study is completed
3 secondary outcomes
Insomnia Severity Index
Time frame: Post-treatment (6 weeks), Three-month follow-up (21 weeks)
Patient health questionnaire (PHQ-9)
Time frame: Post-treatment (6 weeks), Three-month follow-up (21 weeks)
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: Post-treatment (6 weeks), Three-month follow-up (21 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 10 Jun 2022.
- Derived from this study: PubMed 36085009Cassel M, Blom K, Gatzacis J, Renblad P, Kaldo V, Jernelov S. Clinical feasibility of cognitive behavioural therapy for insomnia in a real-world mixed sample at a specialized psychiatric outpatient clinic. BMC Psychiatry. 2022 Sep 9;22(1):600. doi: 10.1186/s12888-022-04231-4.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Susanna Jernelöv, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-i in people with Anxiety Disorders and Affective Disorders, run by Karolinska Institutet 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 5 inclusion and 2 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 10 Jun 2022. 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?
Number of participants registering to participate in the treatment (time frame: Screening). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05379244, which also lists 1 linked publication.
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 10 Jun 2022.