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出境医 / 临床实验 / The Internet Therapy for Depression Trial (INTEREST)

The Internet Therapy for Depression Trial (INTEREST)

Study Description
Brief Summary:
The objective of this trial is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) interventions tailored towards the treatment of depression and chronic pain using a doubly-randomized, attention-controlled, non-blinded, patient-preference design.

Condition or disease Intervention/treatment Phase
Chronic Pain Major Depressive Disorder Behavioral: internet delivered cognitive behavioural therapy (iCBT) Behavioral: online delivered acceptance and commitment therapy (iACT) Other: Attention Control (AC) Not Applicable

Detailed Description:
The primary objective is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) on depressed mood among individuals with chronic pain relative to attention control (AC). The secondary objectives are to evaluate the efficacy of iCBT and iACT on clinically relevant outcomes endorsed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). Adults with chronic non-cancer pain and major depression will be randomized to receive iACT, iCBT, or AC. The interventions comprise 7 weekly online modules available through Therapist Assisted Online (TAO). Patients will be contacted weekly by a member of the study team who will be acting as their personalized "online therapy coach."
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Doubly-randomized, patient-preference trial with two active study interventions and one control.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: A research assistant not affiliated with the study will use Research Randomizer (http://www.randomizer.org/) to generate lists of randomly sequenced numbers to allocate patients to trial arm. To reduce biases and expectation effects, the research assistant will not be aware of what condition the patients are allocated when conducting baseline assessments and a research assistant not affiliated with the research will complete outcome assessments without being aware of allocation. Interventionists will be aware of which group patients are allocated to, as will patients.
Primary Purpose: Treatment
Official Title: The Internet Therapy for Depression Trial (INTEREST): A Doubly-randomized, Patient-preference, Controlled Feasibility Trial Comparing iACT, iCBT, and Attention Control
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: internet delivered cognitive behavioural therapy (iCBT)
The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) thoughts and feelings; 3) understanding stress and relaxation; 4) unhealthy and healthy thoughts; 5) layers of thinking; 6) core beliefs; and 7) relationship, lifestyle, problem solving, and relapse prevention. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
 Behavioral: internet delivered cognitive behavioural therapy (iCBT)
The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) thoughts and feelings; 3) understanding stress and relaxation; 4) unhealthy and healthy thoughts; 5) layers of thinking; 6) core beliefs; and 7) relationship, lifestyle, problem solving, and relapse prevention. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
Experimental: online delivered acceptance and commitment therapy (iACT)
The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) introduction to ACT; 3) cognitive fusion and defusion; 4) thinking mind versus observing mind & acceptance; 5) mindfulness; 6) values; and 7) taking action. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
 Behavioral: online delivered acceptance and commitment therapy (iACT)
The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) introduction to ACT; 3) cognitive fusion and defusion; 4) thinking mind versus observing mind & acceptance; 5) mindfulness; 6) values; and 7) taking action. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
Placebo Comparator: Attention Control (AC)
Patients in the control condition will be given access online psychoeducation about depression and chronic pain. They will be provided weekly phone calls to query symptoms and well-being.
 Other: Attention Control (AC)
1-module of psychoeducation about chronic pain and major depression. Weekly contact to complete measures of symptomatology and well-being.
Outcome Measures
Primary Outcome Measures :
  1. Screening and Consent Rates [ Time Frame: Through study completion, up to 2-years ]
    The number of patients with CNCP and suspected major depression who are referred for screening will be recorded. Eligibility rate will be calculated as the number of patients who meet full inclusion criteria divided by the number of patients referred for screening. Number of patients declining referral for screening and reasons for exclusion will be documented. Consent rate will be calculated by dividing the number of patients who consent to undergoing randomization by the number who met full inclusion criteria.

  2. Change in symptoms of depression measured using the Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: Change from baseline to end of treatment (i.e., week 8). ]
    Change in symptoms of depression as measured using the PHQ-9 from baseline to post-intervention. Scores range from 0-27 with higher scores reflecting greater symptoms of depressed mood.

  3. Adherence to intervention measured as frequency of visits to online modules. [ Time Frame: End of treatment (i.e., week 8) ]
    Intervention adherence will be measured using data recorded by Therapist Assisted Online (TAO) program and include: 1) frequency of visits to TAO modules throughout weeks 1 to 8.

  4. Perceived acceptability of treatment measured using qualitative interviews [ Time Frame: Completion of the intervention (i.e., week 8) ]
    Acceptability data will be collected using semi-structured interviews with patients. Open ended questions will be asked to ascertain the following: 1) acceptability of the delivered intervention; 2) perceived value, benefits, harms and unintended consequences of the delivered intervention; 3) perceived need for refinement of the delivered intervention.


Secondary Outcome Measures :
  1. Change in physical function measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI-SF) [ Time Frame: Baseline, 4-weeks, and post-intervention (i.e., week 8) ]
    Change in pain interference between baseline and post-intervention will be measured using the Brief Pain Inventory - Short Form (BPI-SF). Pain interference is measured s the average degree to which pain impacts seven daily activities (e.g., activity, work, sleep). Scores range from 0 to 10 with higher scores reflecting greater pain-related interference.

  2. Change in emotion function measured using the Depression, Anxiety Stress Scale - 21 (DASS-21). [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in depression, anxiety and stress between baseline and post-intervention measured using the Depression, Anxiety Stress Scale - 21 (DASS-21). The DASS is a 21-item Likert scale with questions ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The 21 questions are divided into three scales, each comprising of 7 questions: depression, anxiety, and stress. Scores for each subscale range between 0 and 21 with higher scores reflecting greater levels of depression, anxiety, and stress.

  3. Change in pain severity will be measured using the pain severity composite scale of the Brief Pain Inventory - Short Form (BPI-SF) [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in pain severity between baseline and post-intervention will be measured using the pain severity composite of the Brief Pain Inventory - Short Form (BPI-SF). Pain severity is measured using the average rating of pain made across the previous 24-hour period (e.g., average pain, worst pain, least pain). Scores range from 0 to 10 with higher scores reflecting greater pain severity.

  4. Change in psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI). [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in psychological flexibility between baseline and post-intervention measured using the Multidimensional Psychological Flexibility Inventory (MPFI). The MPFI is a 60-item scale measuring 6 dimensions of psychological flexibility and 6 dimensions of psychological inflexibility as posited by the Hexaflex model. Each item is rated on a 6-point scale ranging from 1 (never or never true) to 6 (always or always true). Measures of psychological flexibility and inflexibility are calculated as the average score across the subscales representing each dimension. Scores range from 1 to 6 with higher scores representing higher levels of the dimensions being assessed.

  5. Mediators of change for cognitive behavioural therapy measured using change in the cognitive behavioural therapy skills questionnaire. [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in cognitive behavioural therapy (CBT) skill utilization among patients allocated to the CBT group will be measured among patients assigned to the CBT group using the CBT skills questionnaire. The CBT skills questionnaire is a 16-item self-report measure that assesses the client's frequency and performance of CBT utilization. It is a 5-point Likert scale ranging from 1 ("I don't do this") to 5 ("I always do this"). Higher scores reflect greater utilization of CBT skills.

  6. Mediators of change for acceptance and commitment therapy measured using change in the acceptance and action questionnaire. [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in acceptance of chronic pain will be measured among patients assigned to the acceptance and commitment therapy (ACT) group using the Acceptance and Action Questionnaire (AAQ-II). The AAQ-II is a 7-item self-report measure. Patients rate how true statements are to them on a scale of 1 (never true) to 7 (always true). Score ranges from 7-49, with higher scores reflecting less acceptance and commitment.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fluent in English
  • 18 years of age or older
  • have a primary diagnosis of chronic non-cancer pain.
  • meet DSM-5 criteria for a diagnosis of major depressive disorder
  • have access to the internet, email, and telephone
  • can commit to the demands and timelines of the trial.
  • Given high comorbidity in this population, patients with sleep disturbance or comorbid anxiety will also be eligible to participate.

Exclusion Criteria:

  • diagnosis of cognitive impairment (e.g., dementia)
  • active suicidal ideation
  • severe psychopathology (e.g., schizophrenia)
  • unable to sign a safety contract for the duration of the trial
  • concurrent participation in psychotherapy.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Josh Rash, PhD 1 + 709-864-7687 jarash@mun.ca

Locations
Layout table for location information
Canada, Newfoundland and Labrador
Memorial University of Newfoundland Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B3X9
Contact: Josh Rash, PhD    1+709-864-7687    jarash@mun.ca   
Sponsors and Collaborators
Memorial University of Newfoundland
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Screening and Consent Rates [ Time Frame: Through study completion, up to 2-years ]
    The number of patients with CNCP and suspected major depression who are referred for screening will be recorded. Eligibility rate will be calculated as the number of patients who meet full inclusion criteria divided by the number of patients referred for screening. Number of patients declining referral for screening and reasons for exclusion will be documented. Consent rate will be calculated by dividing the number of patients who consent to undergoing randomization by the number who met full inclusion criteria.
  • Change in symptoms of depression measured using the Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: Change from baseline to end of treatment (i.e., week 8). ]
    Change in symptoms of depression as measured using the PHQ-9 from baseline to post-intervention. Scores range from 0-27 with higher scores reflecting greater symptoms of depressed mood.
  • Adherence to intervention measured as frequency of visits to online modules. [ Time Frame: End of treatment (i.e., week 8) ]
    Intervention adherence will be measured using data recorded by Therapist Assisted Online (TAO) program and include: 1) frequency of visits to TAO modules throughout weeks 1 to 8.
  • Perceived acceptability of treatment measured using qualitative interviews [ Time Frame: Completion of the intervention (i.e., week 8) ]
    Acceptability data will be collected using semi-structured interviews with patients. Open ended questions will be asked to ascertain the following: 1) acceptability of the delivered intervention; 2) perceived value, benefits, harms and unintended consequences of the delivered intervention; 3) perceived need for refinement of the delivered intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Change in physical function measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI-SF) [ Time Frame: Baseline, 4-weeks, and post-intervention (i.e., week 8) ]
    Change in pain interference between baseline and post-intervention will be measured using the Brief Pain Inventory - Short Form (BPI-SF). Pain interference is measured s the average degree to which pain impacts seven daily activities (e.g., activity, work, sleep). Scores range from 0 to 10 with higher scores reflecting greater pain-related interference.
  • Change in emotion function measured using the Depression, Anxiety Stress Scale - 21 (DASS-21). [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in depression, anxiety and stress between baseline and post-intervention measured using the Depression, Anxiety Stress Scale - 21 (DASS-21). The DASS is a 21-item Likert scale with questions ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The 21 questions are divided into three scales, each comprising of 7 questions: depression, anxiety, and stress. Scores for each subscale range between 0 and 21 with higher scores reflecting greater levels of depression, anxiety, and stress.
  • Change in pain severity will be measured using the pain severity composite scale of the Brief Pain Inventory - Short Form (BPI-SF) [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in pain severity between baseline and post-intervention will be measured using the pain severity composite of the Brief Pain Inventory - Short Form (BPI-SF). Pain severity is measured using the average rating of pain made across the previous 24-hour period (e.g., average pain, worst pain, least pain). Scores range from 0 to 10 with higher scores reflecting greater pain severity.
  • Change in psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI). [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in psychological flexibility between baseline and post-intervention measured using the Multidimensional Psychological Flexibility Inventory (MPFI). The MPFI is a 60-item scale measuring 6 dimensions of psychological flexibility and 6 dimensions of psychological inflexibility as posited by the Hexaflex model. Each item is rated on a 6-point scale ranging from 1 (never or never true) to 6 (always or always true). Measures of psychological flexibility and inflexibility are calculated as the average score across the subscales representing each dimension. Scores range from 1 to 6 with higher scores representing higher levels of the dimensions being assessed.
  • Mediators of change for cognitive behavioural therapy measured using change in the cognitive behavioural therapy skills questionnaire. [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in cognitive behavioural therapy (CBT) skill utilization among patients allocated to the CBT group will be measured among patients assigned to the CBT group using the CBT skills questionnaire. The CBT skills questionnaire is a 16-item self-report measure that assesses the client's frequency and performance of CBT utilization. It is a 5-point Likert scale ranging from 1 ("I don't do this") to 5 ("I always do this"). Higher scores reflect greater utilization of CBT skills.
  • Mediators of change for acceptance and commitment therapy measured using change in the acceptance and action questionnaire. [ Time Frame: Baseline and through study completion, an average of 8-weeks. ]
    Change in acceptance of chronic pain will be measured among patients assigned to the acceptance and commitment therapy (ACT) group using the Acceptance and Action Questionnaire (AAQ-II). The AAQ-II is a 7-item self-report measure. Patients rate how true statements are to them on a scale of 1 (never true) to 7 (always true). Score ranges from 7-49, with higher scores reflecting less acceptance and commitment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Internet Therapy for Depression Trial
Official Title  ICMJE The Internet Therapy for Depression Trial (INTEREST): A Doubly-randomized, Patient-preference, Controlled Feasibility Trial Comparing iACT, iCBT, and Attention Control
Brief Summary The objective of this trial is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) interventions tailored towards the treatment of depression and chronic pain using a doubly-randomized, attention-controlled, non-blinded, patient-preference design.
Detailed Description The primary objective is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) on depressed mood among individuals with chronic pain relative to attention control (AC). The secondary objectives are to evaluate the efficacy of iCBT and iACT on clinically relevant outcomes endorsed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). Adults with chronic non-cancer pain and major depression will be randomized to receive iACT, iCBT, or AC. The interventions comprise 7 weekly online modules available through Therapist Assisted Online (TAO). Patients will be contacted weekly by a member of the study team who will be acting as their personalized "online therapy coach."
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Doubly-randomized, patient-preference trial with two active study interventions and one control.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
A research assistant not affiliated with the study will use Research Randomizer (http://www.randomizer.org/) to generate lists of randomly sequenced numbers to allocate patients to trial arm. To reduce biases and expectation effects, the research assistant will not be aware of what condition the patients are allocated when conducting baseline assessments and a research assistant not affiliated with the research will complete outcome assessments without being aware of allocation. Interventionists will be aware of which group patients are allocated to, as will patients.
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pain
  • Major Depressive Disorder
Intervention  ICMJE
  • Behavioral: internet delivered cognitive behavioural therapy (iCBT)
    The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) thoughts and feelings; 3) understanding stress and relaxation; 4) unhealthy and healthy thoughts; 5) layers of thinking; 6) core beliefs; and 7) relationship, lifestyle, problem solving, and relapse prevention. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
  • Behavioral: online delivered acceptance and commitment therapy (iACT)
    The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) introduction to ACT; 3) cognitive fusion and defusion; 4) thinking mind versus observing mind & acceptance; 5) mindfulness; 6) values; and 7) taking action. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
  • Other: Attention Control (AC)
    1-module of psychoeducation about chronic pain and major depression. Weekly contact to complete measures of symptomatology and well-being.
Study Arms  ICMJE
  • Experimental: internet delivered cognitive behavioural therapy (iCBT)
    The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) thoughts and feelings; 3) understanding stress and relaxation; 4) unhealthy and healthy thoughts; 5) layers of thinking; 6) core beliefs; and 7) relationship, lifestyle, problem solving, and relapse prevention. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
    Intervention: Behavioral: internet delivered cognitive behavioural therapy (iCBT)
  • Experimental: online delivered acceptance and commitment therapy (iACT)
    The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) introduction to ACT; 3) cognitive fusion and defusion; 4) thinking mind versus observing mind & acceptance; 5) mindfulness; 6) values; and 7) taking action. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
    Intervention: Behavioral: online delivered acceptance and commitment therapy (iACT)
  • Placebo Comparator: Attention Control (AC)
    Patients in the control condition will be given access online psychoeducation about depression and chronic pain. They will be provided weekly phone calls to query symptoms and well-being.
    Intervention: Other: Attention Control (AC)
Publications * Bell LV, Cornish P, Flusk D, Garland SN, Rash JA. The INternet ThERapy for deprESsion Trial (INTEREST): protocol for a patient-preference, randomised controlled feasibility trial comparing iACT, iCBT and attention control among individuals with comorbid chronic pain and depression. BMJ Open. 2020 Feb 28;10(2):e033350. doi: 10.1136/bmjopen-2019-033350.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fluent in English
  • 18 years of age or older
  • have a primary diagnosis of chronic non-cancer pain.
  • meet DSM-5 criteria for a diagnosis of major depressive disorder
  • have access to the internet, email, and telephone
  • can commit to the demands and timelines of the trial.
  • Given high comorbidity in this population, patients with sleep disturbance or comorbid anxiety will also be eligible to participate.

Exclusion Criteria:

  • diagnosis of cognitive impairment (e.g., dementia)
  • active suicidal ideation
  • severe psychopathology (e.g., schizophrenia)
  • unable to sign a safety contract for the duration of the trial
  • concurrent participation in psychotherapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Josh Rash, PhD 1 + 709-864-7687 jarash@mun.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009135
Other Study ID Numbers  ICMJE HREB2018.275
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Joshua Rash, Memorial University of Newfoundland
Study Sponsor  ICMJE Memorial University of Newfoundland
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Memorial University of Newfoundland
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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