Anxiety, Mental Depression, Mental Disorder, Mental Health Issue, Mental Stress, Rumination - Thoughts
Conditions
Brief summary
The goal of this clinical trial is to compare the effect and time consumption of the Swedish translation of the protocol for RNT-ACT with the internet administrated self-help treatment with therapist support (iCBT) for patients seeking medical care for depression, anxiety or stress at their primary care unit. The trial consists of a feasibility study and a randomized controlled trial with 3- and 12-month follow ups.
Detailed description
The main question it aims to answer are: Is the Swedish translation of a psychological treatment protocol targeting Repetitive Negative Thinking (RNT) based on Acceptance and Commitment therapy (ACT), RNT-ACT, an effective treatment in Swedish primary care for the treatment of people with a high proportion of negative repetitive thoughts, who meet diagnostic criteria for depression and/or anxiety? The question is planned to be elaborated into the following parts: A feasibility study in which the material and the system are tested at a single care center. A randomized controlled trial conducted at several health centers where the comparison group is patients who are actualized for traditional psychological treatment in the form of iCBT for either anxiety or depression programs and where they are offered the second treatment arm after 3- and 12-month follow-ups. A follow-up study where time consumption and patient satisfaction are evaluated in both branches. Participants will be given either RNT-ACT or iCBT as treatment. The group who are given RNT-ACT will receive 2\*60 minutes of therapy along with mindfulness files to listen to daily between sessions. The group who are given iCBT will receive internet-based Cognitive Behavioral Therapy, one of the forms of delivering Cognitive behavioral therapy that is implemented in Region Skåne and can thus be seen as treatment as usual. Patients will access the treatment through a secure website and communicate with their therapist by text when needed. Researchers will compare the RNT-ACT and iCBT groups to see if there are differences in depressive, anxiety- and stress- related symptoms, rumination, psychological flexibility, client satisfaction and therapist-rated time consumption. In the feasibility study researchers will also evaluate drop-out and recruitment rate.
Interventions
BEHAVIORALRNT-ACT Protocol
Swedish Translation of the 2\*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.
BEHAVIORALiCBT Treatment
Internet-based Cognitive Behavioral Therapy as mandatory routine care in Swedish Primary care and therefore considered Treatment as usual.
Sponsors
Lund University
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients are made aware of the study through information material at the primary care unit in the waiting room and on the therapists door. There they can notify the contact person about their interest. Letter with information about the study will be sent out to the interested patient. If the patient chooses to participate by answering positively on the information letter, they will be contacted by telephone by a psychologist at the respective primary care unit for the opportunity to ask questions and to book an appointment for a baseline measurement at the unit. After the baseline measurement the patient is randomly assigned to one of the treatment arms. Measurements with all self-assessment scales are carried out at week 0, at the end of treatment and 3 months after the end of treatment. The participants are then offered the opportunity for a follow-up 12 months after completion of treatment using the same scales as the 3-month follow-up.
Intervention model description
After assessment the participant receives either the RNT-ACT arm or the iCBT arm. When the treatment is finished, the patient is called to an evaluation visit. If the person still needs care, we are faced with two choices. Either the patient is offered usual care and is thus removed from the three-month follow-up.Or it will wait for three-month follow up.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* DASS-21 \>25 * Ability to communicate in Swedish orally and in writing
Exclusion criteria
* Routine blood tests are carried out including blood count, thyroid hormone, liver status and fluid balance in order to be able to differentially diagnose any physical illness. In addition to physical illness are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DASS-21 | From assessment to 3 month follow up. | Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63 with high values associated with more Depression/Anxiety/Stress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | one month. | How many patients were recruited on average for one month in the primary care unit responsible for the feasibility study. |
| CSQ-8 | From assessment to 3 month follow up. | Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction. |
| Self registered time consumption | Up to three months. | Self-registered time consumption for therapists. |
| WAI | From assessment to 3 month follow up. | Working Alliance Inventory (WAI). Min 7, Max 84 with higher values indicating better working alliance. |
| Drop Out rate | Up to three months. | Percentage of patients who for any reason fails to continue in the trial until the end of intervention. |
| BSRI | From assessment to 3 month follow up. | Brief State Rumination Inventory (BSRI). Min 0, Max 80. A higher value indicates higher degree of ongoing ruminative cognitive responses. |
| SAAQ | From assessment to 3 month follow up. | Swedish Acceptance and Action Questionnaire (SAAQ). Min 6, Max 42. A higher value indicates lower psychological flexibility which indicates a worse value. |
| AFQ-Y8 | From assessment to 3 month follow up. | Avoidance and Fusion Questionnaire for Youth (AFQ-Y8). Min 0, Max 32. A higher value indicates lower psychological flexibility which indicates a worse value. |
| CFQ-7 | From assessment to 3 month follow up. | Cognitive Fusion Questionnaire - 7 items (CFQ-7). Min 1, Max 49. A higher value indicates higher cognitive fusion which indicates a worse value. |
| RRS-BR | From assessment to 3 month follow up. | Ruminative Responses Scale - Brooding and Reflection (RRS-BR). Min 5, Max 20. A higher value indicates a higher extent of ruminative response style and self-reflection. |
Countries
Sweden
Outcome results
None listed