Metacognitive Therapy for Depression and Generalized Anxiety Disorder in Primary Health Care, Feasibility of a Blended Mediated Treatment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability, is bMCT an acceptable treatment for primary care patients with depression or GAD?
研究概览
简要总结
The goal of this clinical trial is to investigate a new format of metacognitive therapy (MCT) for primary care patients with depression or generalized anxiety disorder (GAD) called blended MCT (bMCT). What is new about bMCT is that it is given both via the internet and through meetings with a therapist. In this study, we first want to investigate if it is feasible to deliver bMCT in primary health care to patients with depression or GAD. Secondly, we want to investigate whether the format of bMCT can provide as good treatment effects as only personally mediated MCT.
The content of both formats of treatment is based on MCT methods for depression and GAD which have shown to be effective in previous research studies. bMCT means to work with the treatment independently via an internet platform and to meet the therapist for therapy sessions up to 6 times during the course of the treatment. Meetings will take place at the primary care center or via video call. As part of the treatment are mediated via the internet, participants need to have access to an Internet-connected computer/electronic device and be able to work with the material about 3 hours per week during the course of the treatment. Standard MCT involves seeing the therapist for 8-12 treatment sessions at the primary care center or via video call.
In the first study, all patients diagnosed with depression or GAD at Liljeholmen primary care center, after giving informed consent, will receive bMCT. In the second study, more primary health care centers will be involved and participants will be randomly allocated to either bMCT or standard MCT.
The active treatment lasts for 8-12 weeks. The treatment is estimated to involve approximately 3 hours of therapy work per week. Participants will be asked to fill in questionnaires before the treatment, weekly during the treatment, immediately after the treatment (post-treatment) and follow-ups at 6 and 12 months after post-treatment. The forms contain questions about your well-being, background and experience of the treatment. Filling in questionnaires is estimated to take 30 minutes on four measurement occasions. Participating also means giving permission for treatment conversations to be audio recorded. The recording is coded so that independent assessors can examine the therapists' competence, and see that the therapists follow the instructions for the current treatment method.
详细描述
Study 1. Feasibility study: Outcome measures of acceptability, feasibility and compliance:
a. What percentage of surveyed patients choose to participate in bMCT? b. What is the dropout rate, given reasons for dropping out? c. How many modules do the patients complete, from 1 to 8? d. patient satisfaction with treatment (Client Satisfaction Questionnaire, CSQ-8, range from 8 low satisfaction to 32 high satisfaction) d. Any reported negative effects of treatment e. Adherence and competence in delivering MCT sessions (MCT-Competence Scale, MCT-CS, 18 items, scale 0-5)
Study1: Experience and Usability, qualitative method:
- How are bMCT and treatment materials experienced by patients and therapists respectively?
- What facilitates and hinders the implementation of bMCT?
Study1: Preliminary clinical effects:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed depressive episode/recurrent depression (ICD code F32., F33.), or generalized anxiety disorder (ICD code F41.1) as primary diagnosis
- •Informed consent
- •Access to the internet
- •Age ≥18 years
- •In the event of psychopharmaceutical medication (e.g. antidepressants), the dosage must have been stable at least 4 years before inclusion
排除标准
- •Other psychiatric condition in need of immediate treatment and/or assessed to be the patient's primary problem (e.g. bipolar disorder, psychosis, alcohol or substance use syndrome or severe eating disorder),
- •Other ongoing psychological treatment
- •Insufficient knowledge of the Swedish language (e.g. that an interpreter is needed during patient visits), cognitive failure or insufficient computer skills to be able to assimilate the text-based digital part of the treatment.
研究组 & 干预措施
Blended metacognitive therapy (bMCT)
Blended metacognitive therapy (bMCT): New about this treatment is that it is given both via the internet and through meetings with a therapist. Participants work with the treatment independently via an internet platform and meet their therapist for therapy sessions up to 6 times during the course of the treatment.
干预措施: Metacognitive therapy, blended format (Behavioral)
结局指标
主要结局
Acceptability, is bMCT an acceptable treatment for primary care patients with depression or GAD?
时间窗: Measurements are delivered at enrollment before treatment, during treatment week 1 to 12, and post-treatment after 12 weeks.
What percentage of surveyed patients choose to participate in bMCT? Measured as percentage of surveyed and eligible patients with a diagnosis of depression or GAD who agree to participate in the treatment study.
Adherence, do the participating patients fulfill the bMCT modules?
时间窗: Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months after post-treatment, and 12 months after post-treatment.
How many modules in the bMCT protocol do the patients complete, from 1 to 8? Measured by number of gathered patient-reported assignments, one for each module out of eight in the SoB-portal.
What is the dropout rate of included patients in bMCT?
时间窗: Measurements are reported during treatment if interrupted and summarized post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).
Dropout rate is measured as percentage of included patients who choose to drop out before the completion of bMCT treatment.
Satisfaction with bMCT treatment
时间窗: Measurements are delivered at post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).
Patient satisfaction with treatment will be measured with the Client Satisfaction Questionnaire, CSQ-8, which ranges from 8 "low satisfaction" to 32 "high satisfaction" with treatment.
Any reported negative effects of bMCT?
时间窗: Measurements are delivered at post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions).
Measured with the Negative Effects Questionnaire, NEQ, 32 items where participating patients report on a Likert scale 0 to 4, thus, a total range of 0 "no reported negative effects" to 128 "maximum reported negative effects".
The therapists' competence in carrying out the bMCT treatment
时间窗: Sessions are audio-recorded during treatment week 1 to 12, assessments of the recordings are carried out post-treatment after 12 weeks up to 6 months post-treatment.
All treatment sessions are audio-recorded. For each therapist three randomly selected recordings are assessed for a total score on the Metacognitive Therapy Competence Scale, MCT-CS, witch includes 18 items and rates competence on a Likert scale that ranges from 0 "not done, not applicable " to 5 "very good level", thus, a total scale ranging from 0 to 90. Assessments are performed by external independent expert assessors with deep knowledge of MCT and prior experience in using the MCT-CS scale.
Patients experience of bMCT, qualitative method
时间窗: Interviews are carried out post-treatment when treatment is finished after 10 weeks up to two months post treatment (treatment range 6 to maximum of 12 treatment sessions).
Individual semi structured interviews are performed with a selection of participating patients post treatment with questions about their experiences of bMCT. Interviews are audio-recorded and transcribed verbatim for qualitative content analysis.
Therapists' experience of carrying out bMCT, qualitative method
时间窗: Focus group discussion with participating therapists is carried out post treatment when all patients in the feasibility study have finished treatment 12 weeks up to 6 months post treatment.
Focus group interview with participating therapists. Semi structured questions and discussions about their experiences of mediating bMCT. Audio-recorded discussions are transcribed and analyzed with qualitative content analysis.
What facilitates the implementation of bMCT? Qualitative method
时间窗: Interviews with patients are carried out post-treatment after 12 weeks up to two months post treatment. Focus group with therapists when all patients in the feasibility study have finished treatment 12 weeks up to 6 months post treatment.
Individual interviews with a selection of participating patients and focus group interview with participating therapists. Semi structured questions about perceived facilitators of bMCT. Audio-recorded discussions are transcribed and analyzed with qualitative content analysis.
What hinders the implementation of bMCT? Qualitative method
时间窗: Interviews with patients are carried out post-treatment, after 12 weeks, and focus group with therapists when all patients in the feasibility study have finished treatment 12 weeks up to 6 months post treatment.
Individual interviews with a selection of participating patients and focus group interview with participating therapists. Semi structured questions about perceived hindering factors of bMCT. Audio-recorded discussions are transcribed and analyzed with qualitative content analysis.
次要结局
- Preliminary clinical effects of bMCT, change in depressive symptoms(Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.)
- Preliminary clinical effects of bMCT, change in symptoms of generalized anxiety disorder (GAD)(Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.)
- Preliminary clinical effects of bMCT, change in quality of life(Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.)
- Preliminary clinical effects of bMCT, change in functional level(Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.)
- Preliminary clinical effects of bMCT, self-assessed ability to work(Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.)
- Preliminary clinical effects of bMCT, change in symptoms of insomnia(Measurements are delivered at enrollment pre-treatment, post-treatment when treatment is finished after 10 weeks (treatment range 6 to maximum of 12 treatment sessions), six months efter post-treatment, and 12 months after post-treatment.)