Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall purpose with this investigation is to further our knowledge about cognitive behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and moderators. The first aim that will be addressed is to explore the efficacy of the CBT components with a dismantling-treatment strategy. Two active CBT interventions, intended to define its components - cognitive therapy and behavior therapy - will be compared with one another as well as with a waitlist condition on a broad range of outcomes at five to nine assessment points depending on the measures. The design will thus enable us to examine what CBT component or components are necessary, sufficient and facilitative of therapeutic change. The second aim that will be explored is to investigate what processes occur in CBT that may contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed, napping, bedtime variability, and rise time variability. The hypothesis is that cognitive processes will mediate cognitive therapy outcomes, and that behavioral factors will have a mediating role for behavior therapy improvements. The third aim that will be addressed is to examine what patient characteristics does CBT depend on to be effective with a treatment-moderator strategy. To investigate moderators for CBT, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical co-morbidity, behavioral and cognitive processes used as mediators will also be employed as moderators.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavior Therapy | Experimental |
| |
| Cognitive Therapy | Experimental |
| |
| Waitlist | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Therapy | Behavioral | Cognitive Therapy involves challenging negative automatic thoughts about sleep and the use of behavioral experiments to challenge and test five cognitive processes (i.e., worry, dysfunctional thoughts, monitoring, safety behaviours, misperception) proposed to perpetuate insomnia. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on the insomnia severity index (ISI). | Pretreatment (week 0), during treatment (i.e., at week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on the Work and Social Adjustment Scale (WSAS). | Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment. | |
| Changes in sleep onset latency (SOL). | Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10). |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility Expectancy Questionnaire (CEQ ). | During the first treatment module. | |
| Client Satisfaction Questionnaire (CSQ-8). | Post-treatment (week 10). | |
| Activity and adherence with treatment protocol (self developed questionnaire assessing treatment activity and adherence relating to text, homework and therapist support). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Markus Jansson Fröjmark, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholm University | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36074617 | Derived | Sunnhed R, Hesser H, Andersson G, Carlbring P, Lindner P, Harvey AG, Jansson-Frojmark M. Mediators of cognitive therapy and behavior therapy for insomnia disorder: A test of the processes in the cognitive model. J Consult Clin Psychol. 2022 Sep;90(9):696-708. doi: 10.1037/ccp0000756. Epub 2022 Sep 8. | |
| 33630618 | Derived |
| Label | URL |
|---|---|
| Comparative Efficacy of Behavior Therapy, Cognitive Therapy, and Cognitive Behavior Therapy for Chronic Insomnia: A Randomized Controlled Trial | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D017008 | Negotiating |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Behavior Therapy | Behavioral | Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles. |
|
| Waitlist. | Behavioral | The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups. |
|
| Changes in wake time after sleep onset (WASO). | Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10). |
| Changes in early morning awakenings (EMA). | Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10). |
| Changes in total sleep time (TST). | Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10). |
| Changes in Hospital Anxiety and Depression Scale (HADS) | Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment. |
| Changes in nighttime symptoms, by using item 1 - 3 from the primary outcome measure. | Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment. |
| Changes in impairment, by using item 5 and 6 from the primary outcome measure. | Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment. |
| Changes in distress, by using item 4 and 7 from the primary outcome measure. | Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment. |
| Changes in Brunnsviken Brief Quality of life index (BBQ) | Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment. |
| Post-treatment (week 10). |
| Sick-leave and other concomitant treatment (self developed questionnaire). | Post-treatment (week 10). |
| Adverse events (questionnaire from a previous similar study). | Post-treatment (week 10). |
| Changes in physical activity (self developed questionnaire). | Pretreatment (week 0) and post-treatment (week 10). |
| Changes in Ford Insomnia Response To Stress Test (FIRST). | Pretreatment (week 0) and post-treatment (week 10) for the waitlist. |
| Changes in Daytime Insomnia Symptom Response Scale (DISRS) | Pretreatment (week 0) and post-treatment (week 10) for the waitlist. |
| Montgomery Åsberg Depression Rating Scale (MADRS). | Pretreatment (week 0). |
| Changes in suicide risk (Item 9 from the MADRS). | Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment. |
| Blanken TF, Jansson-Frojmark M, Sunnhed R, Lancee J. Symptom-specific effects of cognitive therapy and behavior therapy for insomnia: A network intervention analysis. J Consult Clin Psychol. 2021 Apr;89(4):364-370. doi: 10.1037/ccp0000625. Epub 2021 Feb 25. |
| 31608389 | Derived | Sunnhed R, Hesser H, Andersson G, Carlbring P, Morin CM, Harvey AG, Jansson-Frojmark M. Comparing internet-delivered cognitive therapy and behavior therapy with telephone support for insomnia disorder: a randomized controlled trial. Sleep. 2020 Feb 13;43(2):zsz245. doi: 10.1093/sleep/zsz245. |
| D001523 |
| Mental Disorders |
| D003142 | Communication |
| D001519 | Behavior |
| D006298 | Health Services Administration |