Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001614280
Ethics application status
Approved
Date submitted
8/07/2018
Date registered
28/09/2018
Date last updated
28/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a group cognitive behavioral therapy with focus on worry and rumination lead to reduced comorbid mental health problems such as anxiety, depression and sleep problems for primary care patients?
Scientific title
Problems rarely comes alone - A randomized controlled trial of the effects from a transdiagnostic group cognitive behavioral therapy for primary care patients with excessive worry and rumination combined with elevated symptoms of anxiety, depression and/or insomnia, on excessive worry and rumination and symptoms of anxiety, depression and insomnia.
Secondary ID [1] 295322 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RESPIT (Rumination Emotions Sleep Primary care Intervention Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 308516 0
Anxiety disorders 308517 0
Insomnia 308518 0
Condition category
Condition code
Mental Health 307486 307486 0 0
Anxiety
Mental Health 307487 307487 0 0
Depression
Mental Health 307488 307488 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rumination focused Cognitive Behavioral Therapy (RFCBT) is based on general CBT principles: for example psychoeducation (viewing emotional regulation strategies such worry and rumination as mental habits automatically triggered in stressful situations and detained by negative reinforcement), functional analysis, behavioral activation, behavioral experiments, homework and relapse prevention. In this study, RFCBT consists of eight sessions in a group setting over 8 weeks (90 minutes per session: in total 8 x 90 min = 720 min therapy) where participants work with functional management strategies as opposed to repetitive negative thinking such as shifting from abstract to specific thinking, partly with visual imagery techniques. In stressful situations, participants are advised to try shifting the abstract thinking style associated with worrying to a more concrete style (e.g. "what do I need to do and how do I do it?" as opposed to "why am I such a looser?" or "are things ever going to get better?" . Mindfulness and self compassion strategies are also being used as as alternatives to worry and rumination. The use of dysfunctional emotional regulation strategies such as worry and rumination have been shown to be transdiagnostic maintaining factors in a variety of psychological problems. Therefore, the theoretical idea behind RFCBT is if we impact the automatic use of these emotional regulation strategies in stressful situations and events (stressors) and instead exercise an extended repertoire of more functional emotional regulation strategies, a wide range of mental problems will be improved. The strategies practiced in treatment can broadly be described as shifting from avoidance to engaged behaviors such as in behavioral experiments or in behavioral activation. Visualizing concrete activities and shifting from abstract to concrete thinking are specific techniques used in this study aiming to target worry and rumination. The therapy groups will consist of up to 10 participants (minimum of 6) and be administrated by two therapists per groups: one registered clinical psychologist and a student from the master of clinical psychology program. Attendance will be taken. Participant diaries will not be used. Homework is an integral part of this treatment and will take about 45 min to complete per week, spread over the week. The homework done each week are simply an extension of the theory and practice provided in session and consists of tasks such as worry diary, setting goals, functional analysis, if - then plans, shifting thinking style, presence in activities, visualizing concrete activities, self compassion, identifying and acting according to values, relating to and learning from experience and finally relapse prevention. A typical therapy sessions involves a review of last week's homework, a short lecture with new theoretical content (treatment rationale for different techniques), workshop exercises individually and in small groups (overseen by therapists), group discussions about the treatment content and the participants' experiences, and lastly new home work assignments.
Intervention code [1] 301647 0
Behaviour
Intervention code [2] 301679 0
Rehabilitation
Intervention code [3] 301680 0
Treatment: Other
Comparator / control treatment
No treatment (Wait list control group), which will receive their treatment six months after the intervention concludes for the intervention groups.
Control group
Active

Outcomes
Primary outcome [1] 306462 0
Anxiety via the Overall Anxiety Severity and Impairment Scale (OASIS: Norman, Cissell, Means-Christensen., & Stein, 2006)
Timepoint [1] 306462 0
Pre-, mid- (4 weeks), post-treatment (8 weeks) and follow up (6 month)
Primary outcome [2] 306953 0
Depressive symptoms via the Montgomery Åsberg Depression Rating Scale (MADRS-S; Svanborg & Åsberg, 1994)
Timepoint [2] 306953 0
Pre-, mid- (4 weeks), post-treatment (8 weeks) and follow up (6 month)
Primary outcome [3] 306954 0
Insomnia issues via The Insomnia Severity Index (ISI; Bastien, Vallieres, & Morin, 2001) and sleep diary
Timepoint [3] 306954 0
Pre-, mid- (4 weeks), post-treatment (8 weeks) and follow up (6 month)
Secondary outcome [1] 348622 0
Life quality via the Brunnsviken Brief Quality of Life Scale (BBQ; Lindner et al., 2016).
Timepoint [1] 348622 0
Pre-, mid- (4 weeks), post-treatment and follow up after 6 month
Secondary outcome [2] 350216 0
General worrying the Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990)
Timepoint [2] 350216 0
Pre-, mid- (4 weeks), post-treatment and follow up after 6 month
Secondary outcome [3] 350217 0
Sleep specific worrying via the Anxiety and Preoccupation about Sleep Questionnaire (APSQ: Jansson-Fröjmark, Harvey, Lundh, Norell-Clarke, & Linton, 2011)
Timepoint [3] 350217 0
Pre-, mid- (4 weeks), post-treatment and follow up after 6 month
Secondary outcome [4] 350218 0
Repetitive negative thinking (which include both worry and rumination) via the Perseverative Thinking Questionnaire (PTQ; Ehring, Zetsche, Weidacker, Wahl, Schönfeld, & Ehlers, 2011).
Timepoint [4] 350218 0
Pre-, mid- (4 weeks), post-treatment and follow up after 6 month
Secondary outcome [5] 350219 0
Side effects will be measured via Negative Effects Questionnaire (NEQ-20; Rozental, Kottorp, Boettcher, Andersson, & Carlbring, 2016).
Timepoint [5] 350219 0
Post-treatment only.

Eligibility
Key inclusion criteria
1. Elevated levels (over 45) of worry via Penn State Worry Questionnaire (PSWQ; Meyer, Miller,
Metzger, & Borkovec, 1990)
2. At least 18 years old
3. If receiving pharmacological treatment for anxiety, depression and/or sleeping disorders the dose must have been stable for at least two months.
4. Symptoms on a clinical level, i.e. meets diagnostic criteria, within at least two areas out of the following: anxiety, depression or insomnia; The problems have persisted for at least 3 months; The person is interested in particpating in group therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Undergoes other concurrent psychological treatment,
2. Current problems that make participation inappropriate, for example ongoing manic or psychotic episodes that require another treatment focus.
3. Personality characteristics that are incompatible with group therapy, such as hostile or extremely shy personality traits.
4. Suicidal tendencies as measured by Question 9 from the Montgomery Åsberg Depression Rating Scale (MADRS-S ; Svanborg & Åsberg, 1994; 4 or above) and from the clinical interview with the MINI (Sheehan, D. V., Lecrubier, Y., Sheehan, K. H., Amorim, P., Janavs, J., Weiller, E., … Dunbar, G. C; 1998)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Block randomization with blocks of 18 participants (9 to intervention and 9 to waiting list control). The randomization and the intervention start as soon as enough participants for one block have been recruited. Thereafter, the recruitment and the randomization continues until 4 blocks are completed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed effect model approach (based on regression analysis). Both within-group and bewteen-group effects will be investigated. Furthermore, interaction effects will be investigated.

Mediators (worrying and rumination) will be investigated with regression based mediation analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2018
Actual
Date of last participant enrolment
Anticipated
31/05/2019
Actual
Date of last data collection
Anticipated
31/05/2020
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 10588 0
Sweden
State/province [1] 10588 0
Värmland

Funding & Sponsors
Funding source category [1] 299911 0
Government body
Name [1] 299911 0
Värmland County Council
Country [1] 299911 0
Sweden
Funding source category [2] 299914 0
University
Name [2] 299914 0
Karlstad University
Country [2] 299914 0
Sweden
Primary sponsor type
University
Name
Karlstad University
Address
Karlstad University
Department of Social and Psychological Studies
651 88 Karlstad
Country
Sweden
Secondary sponsor category [1] 299279 0
Government body
Name [1] 299279 0
Landstinget i Värmland
Address [1] 299279 0
Rosenborgsgatan 50
651 82 Karlstad
Country [1] 299279 0
Sweden
Other collaborator category [1] 280210 0
University
Name [1] 280210 0
Örebro university
Address [1] 280210 0
SCHOOL OF LAW, PSYCHOLOGY AND SOCIAL WORK
Örebro University SE-701 82 Örebro
Country [1] 280210 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300780 0
Regional Ethical Review Board in Uppsala (Sweden)
Ethics committee address [1] 300780 0
Box 1964
751 49 Uppsala
Sweden
Ethics committee country [1] 300780 0
Sweden
Date submitted for ethics approval [1] 300780 0
23/04/2018
Approval date [1] 300780 0
07/06/2018
Ethics approval number [1] 300780 0
Dnr 2018-197

Summary
Brief summary
This study intends to investigate how people with comorbidity between anxiety, depression and insomnia respond to a rumination focused transdiagnostic psychological treatment based on Cognitive Behavioral Therapy (CBT). Anxiety, depression and sleep problems have increased in Sweden in recent decades and comorbidity between these difficulties are common. People with comorbid difficulties often have more severe symptoms and lower ability to function in everyday life. Comorbidity has also been shown to be a risk factor for long-term sick leave. The general purpose of this study is to investigate if a new transdiagnostic treatment is effective for comorbid disorders.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84798 0
Prof Maria Tillfors
Address 84798 0
Karlstad University
Department of Social and Psychological Studies
651 88 Karlstad
Country 84798 0
Sweden
Phone 84798 0
+46 54-7002189
Fax 84798 0
Email 84798 0
maria.tillfors@kau.se
Contact person for public queries
Name 84799 0
Prof Maria Tillfors
Address 84799 0
Karlstad University
Department of Social and Psychological Studies
651 88 Karlstad
Country 84799 0
Sweden
Phone 84799 0
+46 54-7002189
Fax 84799 0
Email 84799 0
maria.tillfors@kau.se
Contact person for scientific queries
Name 84800 0
Prof Maria Tillfors
Address 84800 0
Karlstad University
Department of Social and Psychological Studies
651 88 Karlstad
Country 84800 0
Sweden
Phone 84800 0
+46 54-7002189
Fax 84800 0
Email 84800 0
maria.tillfors@kau.se

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23656Ethical approval  daniel.wallsten@kau.se
23657Informed consent form  daniel.wallsten@kau.se
23658Study protocol  daniel.wallsten@kau.se

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.