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Completed

NCT Number: NCT03015636

Better Sleep in Psychiatric Care - ADHD.

Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with ADHD is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the ADHD itself and to the use of ADHD medication. In a previous pilot study, the investigators developed a version of CBT-i that would target sleep problems in this population. The basis was CBT-i, but with more emphasis on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication), techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep disturbing habits (e.g. not winding down before bed time), that are also common in patients with ADHD. This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and symptoms of ADHD in patients at the ADHD-clinics, Northern Stockholm Psychiatry, Sweden.

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Key information

Conditions

Sleep Problem ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Parasomnias Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of ADHD, Northern Stockholm Psychiatry

Stockholm, 113 21, 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 the ADHD-clinics Northern Stockholm Psychiatry
  • Experiencing sleep problems (subjective report)

Exclusion criteria

  • None

Treatment and study plan

Adjusted CBT-i for ADHD

Behavioral

This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the adult ADHD population. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population. Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs.

Treatment as Usual

Other

Usual care at the ADHD-clinic. This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: Changes from base-line to 10 weeks and 3 months

    7-item, self-rated questionnaire measuring change in insomnia severity.

Secondary outcomes

  1. Actigraphy

    Time frame: Continuously from treatment start (week 1) to the last week of treatment (week 10)

    An actigraph is placed on the participant's arm for one week. It measures participants' activity in the form of movements. It can be used for acquiring data on sleep and daytime activity, including calculated sleep latency, total sleep time, sleep efficiency, wake after sleep onset, variability in sleep timing and daytime activity.

  2. Sleep diary

    Time frame: Changes from base-line to 10 weeks and 3 months

    Daily self-ratings on a number of sleep parameters, resulting in several measures including sleep latency, wake after sleep onset, total sleep time, sleep efficiency, subjective sleep quality and variability in sleep timing

Other outcomes

  1. Brunnsviken brief quality of life scale

    Time frame: Changes from base-line to 10 weeks and 3 months

    12-items self-rating questionnaire measuring quality of life.

  2. Adult ADHD Self-Report Scale

    Time frame: Changes from base-line to 10 weeks and 3 months

    18-items self-report questionnaire measuring ADHD-symptoms.

  3. Dysfunctional Beliefs and Attitudes about Sleep

    Time frame: Changes from base-line to 10 weeks and 3 months

    10-items self-rating questionnaire measuring sleep related cognitions.

  4. Sleep Problems Acceptance Questionnaire

    Time frame: Changes from base-line to 10 weeks and 3 months

    8-items self-rating questionnaire measuring acceptance of sleep problems.

  5. Sleep habits and behaviors

    Time frame: Changes from base-line to 10 weeks and 3 months

    Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the current project and consists of two parts. The first part includes 16 statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7). The other part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning".

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Department of ADHD, Northern Stockholm Psychiatry

Registry information

Official study title

Better Sleep in Psychiatric Care - ADHD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Attention Deficit Hyperactivity Disorder.

Acronym: BSIP-ADHD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2017
Registry last updated
Oct 23, 2019

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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