The Internet Therapy for Depression Trial

NCT04009135 | Completed

• 1 other identifier: HREB2018.275
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Major Depressive Disorder

Keywords

Chronic non-cancer pain; Major depression; Internet therapies; Cognitive behaviour therapy; Acceptance and commitment therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  Through study completion, up to 2-years

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (6)

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

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

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

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

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

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

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

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

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

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

Study Arms (3)

internet delivered cognitive behavioural therapy (iCBT)

EXPERIMENTAL

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)

online delivered acceptance and commitment therapy (iACT)

EXPERIMENTAL

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)

Attention Control (AC)

PLACEBO COMPARATOR

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)

Interventions

internet delivered cognitive behavioural therapy (iCBT) BEHAVIORAL

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.

internet delivered cognitive behavioural therapy (iCBT)

online delivered acceptance and commitment therapy (iACT) BEHAVIORAL

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.

online delivered acceptance and commitment therapy (iACT)

Attention Control (AC) OTHER

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

Attention Control (AC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in English
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1B3X9, Canada

Location

Related Publications (1)

• 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.

  PMID: 32114466 DERIVED

MeSH Terms

Conditions

Chronic Pain; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Doubly-randomized, patient-preference trial with two active study interventions and one control.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 5, 2019
• Study Start: June 10, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

CA (1)