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Chronic PainINTERESTNCT04009135

The Internet Therapy for Depression Trial

A study testing internet delivered cognitive behavioural therapy (iCBT) and online delivered acceptance and commitment therapy (iACT) in people with Chronic Pain and Major Depressive Disorder, run by Memorial University of Newfoundland at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Pain, Major Depressive Disorder
What is being tested?
internet delivered cognitive behavioural therapy (iCBT) and online delivered acceptance and commitment therapy (iACT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteCanada
Study dates
10 Jun 2019to 1 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Memorial University of Newfoundland

    St. John's, Newfoundland and Labrador, A1B3X9

Other trials in Canada

About this study

Official title: The Internet Therapy for Depression Trial (INTEREST): A Doubly-randomized, Patient-preference, Controlled Feasibility Trial Comparing iACT, iCBT, and Attention Control

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.

Read the 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."

Being tested
internet delivered cognitive behavioural therapy (iCBT), online delivered acceptance and commitment therapy (iACT), Attention Control (AC)
Keywords
Chronic non-cancer pain, Major depression, Internet therapies, Cognitive behaviour therapy, Acceptance and commitment therapy
Medical subject headings
Chronic Pain, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • internet delivered cognitive behavioural therapy (iCBT)Behavioural

    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.

  • online delivered acceptance and commitment therapy (iACT)Behavioural

    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.

  • Attention Control (AC)Other

    1-module of psychoeducation about chronic pain and major depression. Weekly contact to complete measures of symptomatology and well-being.

Study groups in NCT04009135
Study groupRoleWhat they receive
internet delivered cognitive behavioural therapy (iCBT)ExperimentalThe 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.
Receives: Behavioral: internet delivered cognitive behavioural therapy (iCBT)
online delivered acceptance and commitment therapy (iACT)ExperimentalThe 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.
Receives: Behavioral: online delivered acceptance and commitment therapy (iACT)
Attention Control (AC)Placebo comparatorPatients 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.
Receives: Other: Attention Control (AC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Screening and Consent Rates

    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.

    Measured: Through study completion, up to 2-years

  2. Change in symptoms of depression measured using the Patient Health Questionnaire - 9 (PHQ-9)

    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.

    Measured: Change from baseline to end of treatment (i.e., week 8).

  3. Adherence to intervention measured as frequency of visits to online modules.

    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.

    Measured: End of treatment (i.e., week 8)

  4. Perceived acceptability of treatment measured using qualitative interviews

    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.

    Measured: Completion of the intervention (i.e., week 8)

Secondary outcomes (6)

  1. Change in physical function measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI-SF)

    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.

    Measured: Baseline, 4-weeks, and post-intervention (i.e., week 8)

  2. Change in emotion function measured using the Depression, Anxiety Stress Scale - 21 (DASS-21).

    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.

    Measured: Baseline and through study completion, an average of 8-weeks.

  3. Change in pain severity will be measured using the pain severity composite scale of the Brief Pain Inventory - Short Form (BPI-SF)

    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.

    Measured: Baseline and through study completion, an average of 8-weeks.

  4. Change in psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI).

    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.

    Measured: Baseline and through study completion, an average of 8-weeks.

  5. Mediators of change for cognitive behavioural therapy measured using change in the cognitive behavioural therapy skills questionnaire.

    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.

    Measured: Baseline and through study completion, an average of 8-weeks.

  6. Mediators of change for acceptance and commitment therapy measured using change in the acceptance and action questionnaire.

    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.

    Measured: Baseline and through study completion, an average of 8-weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start10 Jun 2019
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Doubly-randomized, patient-preference trial with two active study interventions and one control.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009135
Sponsor's protocol ID
HREB2018.275
Acronym
INTEREST
Status last verified
Sep 2021
First submitted
17 Jun 2019
Last updated
16 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 32114466

Questions about this trial

What is this clinical trial studying?

A study testing internet delivered cognitive behavioural therapy (iCBT) and online delivered acceptance and commitment therapy (iACT) in people with Chronic Pain and Major Depressive Disorder, run by Memorial University of Newfoundland at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Screening and Consent Rates (time frame: Through study completion, up to 2-years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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