Clinical trial NCT05673382: CrisisCope: ICBT for Psychological Symptoms Related to Life Crises.
Official title: CrisisCope: Internet-based CBT Intervention for Distress Related to Life Crises.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Anxiety Symptoms
Keywords: Life crises
Randomized controlled trial
Internet-based cognitive behavioral therapy (ICBT)
Internet intervention
Depression
Anxiety
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2023-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After recruitment finished, participants will be randomized to either intervention condition (treatment group) or control condition (wait-list). Participants in the control condition will receive the same treatment once the treatment group has finished the treatment and outcome measures has been collected from both groups.
Primary purpose: TREATMENT

Brief summary: The aim with this study is to investigate the effects of internet-based cognitive behavioral therapy (ICBT) on psychological symptoms related to one or more life crises. The target group is adults (18 years or older) who have symptoms of depression, anxiety, stress, or other psychological distress related to one or more life crises. The ICBT consists of eight modules during eight weeks with weekly support by a therapist and the treatment group will be compared to a wait-list control condition. Participants will be recruited in Sweden with nationwide recruitment.

Detailed description: The study is a randomized controlled trial about the effects of ICBT aiming to target psychological symptoms related to one or more life crises. Primary outcome measures are depressive symptoms (measured with Beck Depression inventory-II) and anxiety symptoms (measured with Generalized Anxiety Disorder-7). Other outcome measures used will for example be about adaptability, stress symptoms, sleep problems, post traumatic stress symptoms and quality of life.

Because the psychological impact of a life crisis can be diverse, between different people and between different kinds of crises, a transdiagnostic individually tailored treatment will be used that has been tested in several previous trials. This treatment has been adopted to target psychological symptoms related to life crises.

Eligibility criteria: Inclusion Criteria:

* Experience psychological symptoms related to one or more life crises.
* 18 years or older
* Adequate ability to speak, read and write Swedish
* Having access to the internet and a smartphone, computer or other device

Exclusion Criteria:

* Severe psychiatric or somatic issues that makes participation harder or impossible
* Ongoing addiction
* Acute suicidality
* Other ongoing psychological treatment
* Recent (within the past three months) changes in dose of psychotropic medication or planned change during the treatment weeks

Primary outcomes:
measure: Beck Depression Inventory-II
timeFrame: Change between Baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Generalized Anxiety Disorder-7
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary outcomes:
measure: Brief Adjustment Scale-6
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination. Also, every week during the treatment weeks.
measure: Patient Health Questionnaire-9
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Perceived Stress Scale-14
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Insomnia Severity Index
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Alcohol Use Disorder Identification Test
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Impact of Events Scale-Revised
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: InCharge Financial Distress/Financial Well-Being Scale
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Medical Outcome Study Social Support Survey
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Posttraumatic Growths Inventory-Short form
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning, Linköping University
state: Östergötland
Study officials:
affiliation: University Hospital, Linkoeping
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: