Clinical trial NCT04106713: Understanding the Person, Exploring Change Across Psychotherapies
Official title: Understanding the Person, Exploring Change Across Psychotherapies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety Disorders
Keywords: Psychotherapy
Cognitive behavioural therapy
Group psychotherapy
Internet-based psychotherapy
Lead sponsor: Institute of Mental Health, Singapore
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

For the psychotherapy arms (iCBT, group CBT, and individual therapy), assessments will be conducted from baseline across the course of participants' psychotherapy interventions as well as into follow-up. A baseline battery will be completed before the start of therapy. The baseline battery includes vulnerability measures, around half of which will serve as the independent variables and the other half will be used to assess outcome, during their first visit (i.e. triage). This series of baseline measures will take approximately 50 min to complete. For iCBT, group CBT and individual therapy, there will be study visits after each session of therapy, whereby participants will be asked to complete a series of additional measures. The series of weekly measures will take approximately 15 min to complete. Any measures that the therapists use regularly when sending out the measures will be left out and the therapist can request for the outcomes to be either emailed or uploaded on C-doc for their reference. After the last session, participants would complete a post-intervention battery besides the post-session measures. The series of post-intervention measures, to be completed above the weekly measures on the last therapy session, will take approximately 45 min to complete.

Mechanisms of change: Process-outcome in Individual Therapy In 30 clients undergoing frequent individual therapy (ideally once a fortnight or more), in addition to the quantitative measurement of outcome, consent will be taken to allow audio with or without video recording of their sessions. Their therapist will also provide consent for recording of sessions. Sessions will be recorded by their therapist. Sessions will be subsequently transcribed and coded with scales to assess alliance-building, interventions, and emotional work. Initial coding will use the comparative psychotherapy process scale, the facilitative interpersonal scale, and the emotional arousal scale according to a coding manual by trained raters.

For every 3 months for two years (if consented to), participants may complete the follow-up measures. For iCBT and group CBT, therapy sessions would take place weekly for 8 weeks. For individual therapy, therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.

Buccal swabs will be obtained from consenting participants at baseline and post-therapy to conduct genome-wide association scanning to construct polygenic risk scores for prediction of response to therapy and assess epigenetics as a vulnerability factor pre-post therapy.

Timeline and list of measures for waitlist and group TAU (refer to appendix): For waitlist/TAU, assessments will be completed at Week 0, Week 4, Week 8 and for follow-ups (see attached Gantt chart).

Participants in the waitlist/ TAU groups will not undergo buccal swabs.

Participants in the waitlist arm would be individuals who have been referred for psychotherapy but would not be undergoing therapy for at least 8 weeks from the point of recruitment into this study, and hence will serve as the control group. It is highly likely that a considerable proportion of participants in the waitlist group would eventually undergo therapy within the period of study follow up (up to 2 years). In this case, the data collected from such participants from before they begin therapy would first be retained, and such participants would also subsequently be recruited into the psychotherapy arm of the study, where they would complete all procedures of the study.

In the event that TAU participants are referred for psychotherapy over the duration of the study, the data collected from such participants from before they begin therapy would first be retained, and also subsequently recruit them into the psychotherapy arm of the study.

Baseline and post-intervention measures will be completed online.

For post-session/ follow-up measures online, Pragmatic Tracker, an official online platform used by the Institute of Mental Health for administering scales to therapy patients, will be utilized. Any measures that the therapists use regularly will be left out when sending out the measures and the therapist can request for the outcomes to be either emailed or uploaded on Cdoc for their reference.

For all groups, psychiatric and medical history, pharmacological and other non-psychological interventions will first be verified during follow-up 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.

Like the therapists, the triage psychologists will also be given a background information form during triage review that probes their experience as a triage officer and general client expectations (Therapist/Triage Officer Background Information Form). It is hypothesized that such evaluations by the triage psychologists may affect treatment outcome. For TAU and Waitlist, the patient's clinician will assist in completing the GAF.

Incidental findings are not anticipated for any patients from this study. Only DNA will be extracted after the collection of the buccal swabs, which would not reveal any incidental findings of potential health and reproductive importance. However, the possibility that a genetic test will be developed in the future that can use the collected data and predict the development of a disease in later life with certainty, and which becomes apparent from the study's analyses, cannot be excluded. This is considered to be unlikely as the study only looks at common genetic variants in this study. The study informs participants of the potential to uncover incidental findings in future research in the ICF, and provide for re-identification of participants in such cases.

There will not be any incidental findings for the therapists as there will not be any biological/clinical tests that the therapists themselves will complete that may reveal potential health or reproductive importance.

Hard copies or soft copies of scales may be administered at all time points or may be administered over the phone, depending on the preference on the participants and licensing permissions. Scales will be made available for completion online wherever possible, except for scales such the Anxiety Sensitivity Index (only allowed to be administered on paper) and EQ5D-L5 (on phone/ paper). Online modes of administration include Pragmatic Tracker, REDCAP and QuestionPro. QuestionPro and REDCAP are research platforms also used by IMH/SICS and have the function of scheduling surveys at several time points.

Eligibility criteria: Inclusion Criteria:

1. For patients:

   1. 18-99 years old;
   2. have current or past symptoms of anxiety and/or depression;
   3. able to communicate and read in English;
   4. able to provide informed consent.
   5. 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.
   6. Treatment as usual:

      - Not assigned to any psychotherapeutic interventions.
   7. iCBT: - Referred for iCBT;

      - Identified as a 'P2' patient/appropriate for iCBT by triage.
   8. Group therapy:

      - Referred for group therapy;

      - Identified as a 'P2' patient/appropriate for group therapy by triage.
   9. Individual psychotherapy:

      * Referred for individual therapy;
      * Patient and therapist committed to frequent therapy (ideally fortnightly).
2. For therapists:

   1. Therapists who will see OR have been assigned to clients in the waitlist arm, iCBT, group therapy (e.g. PsychUp), and individual psychotherapy group.

Exclusion Criteria:

1. For patients:

1. current active suicidal intention or plan;
2. cognitively-impaired/are unable to consent/lack capacity to consent.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: 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.
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) questionnaire score
timeFrame: 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.
measure: Change in Outcome Rating Scale (ORS) score
timeFrame: 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: Change in Work and Social Adjustment Scale (WSAS) score
timeFrame: 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.
Secondary outcomes:
measure: Change in Self-Referential Encoding Task (SRET) performance
timeFrame: 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.
measure: Change in Implicit Association Task (IAT) performance
timeFrame: 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).
measure: Change in Partner Go/No Go Association Task (P-GNAT) performance
timeFrame: 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).
measure: Change in Go/No Go Association Task (GNAT) performance
timeFrame: 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).
measure: Change in Letter-number Sequencing Task performance
timeFrame: 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).
measure: Change in Word Fluency Task performance
timeFrame: 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).
measure: Change in Cognitive Style Questionnaire-Very Short Form (CSQ-VSF) score
timeFrame: 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).
measure: Change in Leiden Index of Depression Sensitivity-Revised Revised(LEIDS-RR) score
timeFrame: 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).
measure: Change in Reconstructed Depressive Experiences Questionnaire (RecDEQ) score
timeFrame: 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).
measure: Change in Dysfunctional Attitudes Scale (DAS-24) score
timeFrame: 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).
measure: Change in Anxiety Sensitivity Index (ASI) score
timeFrame: 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).
measure: Change in Person's Relating to Others Questionnaire (PROQ3) score
timeFrame: 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).
measure: Change in Difficulties in Emotion Regulation Scale Short Form (DERS-SF) score
timeFrame: 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).
measure: Change in Inventory for Depressive Symptomatology (IDS) scores
timeFrame: 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).
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) questionnaire score
timeFrame: 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).
measure: Change in Patient Health Questionnaire-Panic Disorder (PHQ-PD) score
timeFrame: 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).
measure: Change in Positive Mental Health Instrument (PMH) scores
timeFrame: 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)
measure: Change in EuroQol 5-dimension 5-level (EQ-5D-5L) Descriptive System scores
timeFrame: At baseline, and at follow-up every 3 months up to 2 years.
measure: Change in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Scale scores
timeFrame: At baseline, and at follow-up every 3 months up to 2 years.
measure: Change in modified Clinical Global Impression (self-report) scores
timeFrame: 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.
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) scores
timeFrame: 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).
measure: Change in Frequency of Actions and Thoughts Scale (FATS) score
timeFrame: 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.
measure: Change in Clinical Outcomes in Routine Evaluation-10 (CORE-10) score
timeFrame: Immediately after therapy session for 8 sessions (i.e. over 8 weeks for iCBT and group therapy, and approximately 16 weeks for individual therapy)
measure: Change in Working Alliance Inventory-Short Revised (WAI-SR)
timeFrame: Immediately after each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy; approximately 16 weeks for individual therapy).
measure: Feedback Questionnaire
timeFrame: Immediately after each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy; approximately 16 weeks for individual therapy).
measure: Session Rating Scale (SRS)
timeFrame: Immediately after each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy; approximately 16 weeks for individual therapy).
measure: Default rates
timeFrame: During intervention (8 sessions, i.e. over 8 weeks for iCBT and group therapy, or over approximately 16 weeks for individual therapy).
measure: Change in Psychodynamic Functioning Scale (PFS) score
timeFrame: 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).
measure: Change in Global Assessment of Functioning (GAF) score
timeFrame: 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).
measure: Change in Working Alliance Inventory-Short Revised-Clinician (WAI-SR-C) score
timeFrame: 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).
Other outcomes:
measure: Personality Inventory for DSM-5-Brief Form (PID-5-BF)
timeFrame: At baseline.
measure: Eysenck Personality Questionnaire-Revised Short Form Neuroticism Scale (EPQ-R-S-N)
timeFrame: At baseline.
measure: Life Experiences Checklist (LEC)
timeFrame: At baseline, and at follow-up every 3 months up to 2 years.
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: At baseline.
measure: Experiences in Close Relationships Questionnaire-12 (ECR-12)
timeFrame: At baseline.
measure: Adult Rejection Sensitivity Questionnaire (A-RSQ)
timeFrame: At baseline.
measure: Comparative Psychotherapy Process Scale (CPPS)
timeFrame: 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).
measure: Client Task Specific Change Measure Revised (CTSCM-R)
timeFrame: 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).
measure: Cooper-Norcross Inventory of Preferences (CNIP)
timeFrame: At baseline.
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: At baseline.
measure: Client Motivation for Therapy Scale (CMOTS)
timeFrame: At baseline.
measure: Readiness for Psychotherapy Index (RPI)
timeFrame: At baseline.
measure: Medication Adherence Rating Scale (MARS)
timeFrame: At baseline.
measure: Sociodemographics (self-report)
timeFrame: At baseline.
measure: Psychiatric history (self-report)
timeFrame: At baseline.
measure: Treatment history/current treatment interventions
timeFrame: At baseline, and at follow-up every 3 months up to 2 years.
Locations:
city: Singapore
country: Singapore
facility: Institute of Mental Health, Singapore
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Geoffrey CY Tan
role: PRINCIPAL_INVESTIGATOR
References: