Trial Outcomes & Findings for Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression (NCT NCT01681771)

Results Overview

Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score \>10 indicate at least moderate depression.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

9 weeks

Results posted on

2019-06-03

Participant Flow

Recrutiment from medical clinics

No pre-assignment details to report

Participant milestones

Participant milestones
Measure	Cogntive Behaviour Therapy Internet based Cognitive behaviour therapy during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.	Discussion Group Internet moderated discussion group during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional. Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
Overall Study STARTED	25	25
Overall Study COMPLETED	21	23
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cogntive Behaviour Therapy Internet based Cognitive behaviour therapy during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.	Discussion Group Internet moderated discussion group during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional. Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cogntive Behaviour Therapy n=25 Participants Internet based Cognitive behaviour therapy during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.	Discussion Group n=25 Participants Internet moderated discussion group during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional. Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.	Total n=50 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 13.9 • n=5 Participants	62.3 years STANDARD_DEVIATION 11.7 • n=7 Participants	62.9 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 weeks

Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score \>10 indicate at least moderate depression.

Outcome measures

Outcome measures
Measure	Cogntive Behaviour Therapy n=25 Participants Internet based Cognitive behaviour therapy during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.	Discussion Group n=25 Participants Internet moderated discussion group during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional. Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
Depressive Symptoms	8.6 units on a scale Standard Deviation 4.6	9.8 units on a scale Standard Deviation 4.3

Adverse Events

Cognitive Behavoural Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Discussion Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. RN Peter Johansson

Linköping University, Department of social and welfare studies. Linköping University

Phone: +4613313685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place