Understanding the Person, Exploring Change Across Psychotherapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Generalized Anxiety Disorder-7 (GAD-7) questionnaire score
研究概览
简要总结
Identifying predictors and understanding mechanisms of change will inform referral to psychotherapy, triage and right-siting by helping clinicians to understand how their patients are likely to benefit from clinical interventions. This study will be the first of its kind conducted in an Asian hospital setting to identify the predictors of response to individual, group and internet-delivered CBT for the treatment of depressed and anxious patients in the Institute of Mental Health (IMH), Singapore. With increasing challenges with hospital workload, there is an increasing emphasis on group and online interventions. Understanding of the factors that may predict outcome from these therapies can improve right-siting by identifying who will get better without therapy or who may not benefit from a given form of therapy and guide personalisation of care. An important biological predictor of outcome is likely to be genetic risk as it has been demonstrated that patients with greater melancholia and a family history may not be sufficiently treated with brief courses of therapy. Identifying psychological factors underlying psychological distress and determining the extent to which these factors are addressed by these interventions will help to improve and individualise existing psychotherapy and motivate new psychotherapeutic interventions.
详细描述
All IMH outpatients who have been referred for psychotherapy will be invited to take part in this research. Participants will be recruited from triage, outpatient clinics, emergency services and referrals from therapists. In specific, participants under the iCBT and group CBT (for e.g. PsychUp) treatment arms will be recruited from the Psychology Department from triage and those under individual therapy will be recruited from the Psychotherapy Department.
After indicating interest to participate in the study, potential patients will be contacted to explain the purpose of the study and its procedures, obtain informed consent to take part in the study as well as brief them on how to log on and access and complete questionnaires.
Participants will be placed into the study arms (i.e. iCBT, group CBT or individual therapy) based on the intervention program each has been allocated to. Some participants will also form a Delayed Waitlist group. Other participants will form the Treatment as Usual (TAU) group. Participants in the Waitlist group will be recruited from those referred for psychotherapy and who are not assigned to either group or iCBT and not planned for psychotherapy at IMH for 8 weeks or more from the point of consent. Participants in the Treatment as Usual (TAU) group are individuals who are not assigned to psychotherapy at IMH. They will be recruited from outpatient services and emergency services at IMH.
The Waitlist and Treatment as Usual Groups will serve as the control groups.
For all groups, psychiatric and medical history, pharmacological and other non-psychological interventions will first be obtained at baseline in order to control for other treatment effects. Such medical records would be accessed via c-Doc; data will be obtained from information management and the IMH diagnostics. SAP data at IMH, including demographic data, postal code, diagnosis, race, clinician names (but not limited to), will be collected for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients:
- •18-99 years old;
- •have current or past symptoms of anxiety and/or depression;
- •able to communicate and read in English;
- •able to provide informed consent.
- •Waitlist arm:
- •- Referred for psychotherapy but given a waiting time of 8 weeks or more to the first visit or not assigned to therapy at IMH.
- •Treatment as usual:
- •- Not assigned to any psychotherapeutic interventions.
- •iCBT: - Referred for iCBT;
- •- Identified as a 'P2' patient/appropriate for iCBT by triage.
- •Group therapy:
- •- Referred for group therapy;
- •- Identified as a 'P2' patient/appropriate for group therapy by triage.
- •Individual psychotherapy:
- •Referred for individual therapy;
- •Patient and therapist committed to frequent therapy (ideally fortnightly).
- •For therapists:
- •Therapists who will see OR have been assigned to clients in the waitlist arm, iCBT, group therapy (e.g. PsychUp), and individual psychotherapy group.
排除标准
- •1. For patients:
- •current active suicidal intention or plan;
- •cognitively-impaired/are unable to consent/lack capacity to consent.
研究组 & 干预措施
Treatment as Usual (TAU)
Participants in the Treatment as Usual (TAU) group are individuals who are not assigned to psychotherapy at IMH. They will be recruited from outpatient services and emergency services at IMH.
Internet-delivered Cognitive Behavioural Therapy (iCBT)
The iCBT program (clinician follow-up with the therapist and 4 online modules) will be administered for 8 weeks. The four modules: "1) psychoeducation about emotions, including a functional nature of emotions; 2) alteration of antecedent cognitive misappraisals; 3) prevention of emotional avoidance; and 4) modification of emotion-driven [behaviours] (EDBs)", are adapted from The Unified Protocol (UP) for transdiagnostic treatment of emotional disorders. UP is a CBT consisting of four overarching themes- "increasing emotional awareness, facilitating flexibility in appraisals, identifying and preventing [behavioural] and emotional awareness, and situational and interoceptive exposure to emotion cues".
干预措施: Internet-delivered Cognitive Behavioural Therapy (iCBT) (Behavioral)
Group CBT
The group CBT program (for e.g. PsychUp) will be conducted over 8 weeks, with weekly 2-hour sessions. Each group consists of 4-8 patients and are facilitated by two practicing clinical psychologists and one clinical psychologist in training. Sessions are structured such that each session, except the first, begins with a brief review of previous session material and a collaborative review of homework. This is followed by introduction of new material and completion of any in-session exercises, with sessions concluding with homework assignment. Specific treatment content is similarly adapted from UP. Session 1 begins by covering psychoeducation on the CBT model of pathological depression and anxiety and the role of avoidance in maintenance of symptoms. Sessions 2 to 7 covers goal-setting, cognitive reappraisal and development of adaptive emotional coping strategies through situational emotion-focused exposures. Session 8 ends with a discussion on relapse prevention.
干预措施: Group Cognitive Behavioural Therapy (group CBT) (Behavioral)
Delayed Waitlist
Participants in the Waitlist group will be recruited from those referred for psychotherapy and who are not assigned to either group or iCBT and not planned for psychotherapy at IMH for 8 weeks or more from the point of consent.
Individual Therapy
The individual therapy program will differ in orientation according to therapist and session notes will be coded according to the Comparative Psychotherapy Process Scale. Therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.
干预措施: Individual Psychotherapy (Behavioral)
结局指标
主要结局
Change in Generalized Anxiety Disorder-7 (GAD-7) questionnaire score
时间窗: Immediately before each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy, or approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.
Anxiety scale. Total scores range from 0 to 21, with higher scores representing more severe anxiety.
Change in Patient Health Questionnaire-9 (PHQ-9) score
时间窗: Immediately before each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy, or approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.
Depression scale. Total scores range from 0 to 27, with higher scores representing more severe depression.
Change in Outcome Rating Scale (ORS) score
时间窗: Immediately before each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy, or approximately 16 weeks for individual therapy).
Measure assessing general well-being. Total scores range from 0 to 40, with higher scores representing better general well-being.
Change in Work and Social Adjustment Scale (WSAS) score
时间窗: At baseline, at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.
The WSAS is a self-report scale of functional impairment attributable to an identified problem. Total scores range from 0 to 40, with higher scores representing greater functional impairment.
次要结局
- Change in Implicit Association Task (IAT) performance(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Reconstructed Depressive Experiences Questionnaire (RecDEQ) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Feedback Questionnaire(Immediately after each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy; approximately 16 weeks for individual therapy).)
- Change in Self-Referential Encoding Task (SRET) performance(At baseline, at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.)
- Change in Partner Go/No Go Association Task (P-GNAT) performance(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Leiden Index of Depression Sensitivity-Revised Revised(LEIDS-RR) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Dysfunctional Attitudes Scale (DAS-24) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Session Rating Scale (SRS)(Immediately after each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy; approximately 16 weeks for individual therapy).)
- Default rates(During intervention (8 sessions, i.e. over 8 weeks for iCBT and group therapy, or over approximately 16 weeks for individual therapy).)
- Change in Go/No Go Association Task (GNAT) performance(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Letter-number Sequencing Task performance(At baseline, and at post-intervention (immediately after the final and final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Inventory for Depressive Symptomatology (IDS) scores(At baseline (IDS-30), at post-intervention (QIDS-16) (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years (QIDS-16).)
- Change in Generalized Anxiety Disorder-7 (GAD-7) questionnaire score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Positive Mental Health Instrument (PMH) scores(At baseline (PMH-Short), at post-intervention (PMH-Short) (immediately after final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy) and at follow-up every 3 months up to 2 years (PMH-Rapid))
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) scores(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Working Alliance Inventory-Short Revised (WAI-SR)(Immediately after each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy; approximately 16 weeks for individual therapy).)
- Change in Working Alliance Inventory-Short Revised-Clinician (WAI-SR-C) score(Immediately after the first therapy session, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Frequency of Actions and Thoughts Scale (FATS) score(Immediately after each therapy session (i.e. over 8 weeks for iCBT and group therapy, or over approximately 16 weeks for individual therapy), at post-intervention (immediately after final session), and at follow-up every 3 months up to 2 years.)
- Change in Word Fluency Task performance(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Cognitive Style Questionnaire-Very Short Form (CSQ-VSF) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Anxiety Sensitivity Index (ASI) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Person's Relating to Others Questionnaire (PROQ3) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in EuroQol 5-dimension 5-level (EQ-5D-5L) Descriptive System scores(At baseline, and at follow-up every 3 months up to 2 years.)
- Change in modified Clinical Global Impression (self-report) scores(At baseline, at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.)
- Change in Clinical Outcomes in Routine Evaluation-10 (CORE-10) score(Immediately after therapy session for 8 sessions (i.e. over 8 weeks for iCBT and group therapy, and approximately 16 weeks for individual therapy))
- Change in Difficulties in Emotion Regulation Scale Short Form (DERS-SF) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Patient Health Questionnaire-Panic Disorder (PHQ-PD) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Scale scores(At baseline, and at follow-up every 3 months up to 2 years.)
- Change in Psychodynamic Functioning Scale (PFS) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)
- Change in Global Assessment of Functioning (GAF) score(At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).)