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Completed

NCT Number: NCT05379244

Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Stockholm, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • night shift work
  • ongoing alcohol or drug abuse that required treatment at a specialised unit

Treatment and study plan

CBT-I

Behavioral

Behavioral intervention based on Cognitive Behavioral Therapy for insomnia, adjusted for psychiatric patients with anxiety disorders, affective disorders and trauma

Primary outcomes

  1. 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)

  2. 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

  3. Number sessions attended by the participants

    Time frame: Post-treatment (6 weeks)

    Average number of sessions attended should be no less than 3

  4. Number of participants dropping out of treatment

    Time frame: Post-treatment (6 weeks)

    Less than half of the patients should drop out of treatment

  5. 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

Secondary outcomes

  1. Insomnia Severity Index

    Time frame: Post-treatment (6 weeks), Three-month follow-up (21 weeks)

    7-item self-reported measure of insomnia severity, 0-28 points, lower is better.

  2. Patient health questionnaire (PHQ-9)

    Time frame: Post-treatment (6 weeks), Three-month follow-up (21 weeks)

    9-item depression inventory, 0-27 points, lower is better

  3. Generalized Anxiety Disorder Assessment (GAD-7)

    Time frame: Post-treatment (6 weeks), Three-month follow-up (21 weeks)

    7-item anxiety inventory, 0-21 points, lower is better

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Better Sleep in Psychiatric Care - Clinical Feasibility and Preliminary Effects of CBT for Insomnia in a Mixed Psychiatric Sample at an Outpatient Clinic

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 18, 2022
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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